Business Intelligence on Biologic and Small Molecule Drugs

Business Continuity and Resiliency Planning for Biomedical and Research Organizations

business continuity planning

By Nanette Moss, S.M., C.I.H., Senior Scientist and Project Executive with Environmental Health & Engineering, Inc.

Table of Contents

What is business continuity planning and why it is important?

business continuity planning

The types of disruptions might include a severe winter storm (e.g., ice or snow), flood, staff shortage, supply-chain interruption, power failure, loss of water, computer or telecommunications downtime, cyber-attack or security emergency (e.g. violence in the workplace). Such disruptions can result in delays in product launches, clinical trials and regulatory reporting, loss of clients, sponsors or collaborators and patient outcomes or potential societal impact due to drug shortages or delayed diagnostic services.

A Business Continuity Plan vs. an Emergency Action Plan

Organizations should have both an Emergency Action Plan (EAP) and a BCP. An EAP addresses short duration emergencies that are usually immediate, site-specific or incident-specific, such as how to: report and respond to fires, evacuate the building, clean up a chemical spill or get medical attention for personnel accidents. The scope of a BCP typically includes the entire organization, applies to all forms of emergencies and has a long-term focus on the continuation of essential operations for protection of not only personnel and property but also research assets (e.g. biological materials and laboratory animals), products, reputation and investments.

Unique Challenges

Biomedical and research organizations face unique challenges in resiliency planning because these facilities often include large specialized equipment, vivariums, insectariums, aquatic animal housing or spaces that require continuous environmental control and monitoring. This makes it impractical or impossible to establish temporary operations at an alternative site during a long-lasting disaster. In addition, laboratories that maintain accreditations or licenses from regulatory agencies or organizations may be required to conduct their operations only in the licensed facility. That means that all possible resources must be devoted to bringing the facility back into operation as quickly as possible during or after a crisis.

Biomedical and research organizations may also have unique vulnerabilities. For example, specialized laboratory equipment may require use of vendor-specific consumable products and certain reagents or rare products may only be available from a single vendor or may have long lead-time constraints. Qualifying back-up vendors and off-site warehousing of these critical supplies can serve to off-set these liabilities. Preserving temperature sensitive materials, common to this industry, must be considered as power disruptions are not uncommon and emergency generators cannot always be relied upon for long-term or large-scale regional disasters. Banking or relocating critical biological materials to a cold storage biorepository can assure that these assets are protected and can be readily retrieved once operations are restored.

Staffing issues also present challenges because specialized training and qualifications are usually required to perform critical functions in a high-technology environment. These employees cannot be easily replaced in the event of a staff shortage due to situations such as epidemics or road closures. Some organizations might consider comprehensive cross-training programs to address these types of staffing interruptions.

Finally, biomedical and research organizations require complex information technology services and support including systems to ensure data security, availability, processing integrity, confidentiality, and privacy. Management systems should be developed to provide data backup, cloud storage, virtual desktop infrastructure and redundancies for internet access and other vital system components.

How To Create a Successful Business Continuity Program

  • Risk Assessment and Business Impact Analysis

The first step to creating a BCP is to conduct a risk assessment and business impact analysis. This is essentially the foundation for a comprehensive BCP. It involves identifying the types of threats that may impact the organization (e.g. hurricane, cyber-attack, supply-chain disruption) and estimating the probability of an occurrence and the severity of the impact. It will help you to develop strategies for preventing serious incidents that could compromise the facility and its operations, as well as to develop mitigation measures to minimize the consequences and severity of incidents that cannot be prevented.

One must then identify your organization’s:

  • Critical functions and operations
  • Vulnerabilities (e.g. single-source suppliers, facility location in flood zone, only one emergency generator, etc.)
  • Resources needed for recovery (e.g. staff, supplies, equipment, facility, utility systems, technology, finances and vital records)

Next, estimate the impact resulting from recovery delays such as loss of revenue, customers, company reputation, products or investments. Develop and implement prevention and mitigation measures to offset the vulnerabilities.

  • Recovery Objectives, Strategies, Tasks and Timeframes

Once the Risk Assessment and Business Impact Analysis is completed, you can now establish recovery objectives, strategies, tasks and timeframes. This may include relocating critical biological materials to a temperature-controlled biorepository, temporarily using a reference laboratory, relocating some operations to an academic core facility, switching production to another company site, using back-up vendors or having staff work remotely. In some situations, it may not be possible or safe for staff to enter the facility or there may be circumstances where staff may be unable or unwilling to come to the worksite (e.g., employees were injured, emotionally affected by the disaster, need to care for family members). If it is possible for staff to work remotely or at temporary alternate locations, it is important to ensure that technology support is available such as VPN access or remote logon capabilities.

  • Communications

An essential component of a BCP includes steps or procedures for internal and external communications. Employees must be notified of the emergency situation and instructed whether to come to work or stay home. These notifications can be accomplished by using mass electronic notification software systems, telephone call trees, group texts and social media platforms. Keeping employees well informed regarding situation developments and providing instructions and expectations is essential to maintain a calm and organized response to disruptions.

Communication with external organizations such as fire departments, police, public health and emergency response units is necessary to obtain critical information regarding the emergency and request assistance if necessary. Other stakeholders may need to be notified such as regulatory agencies, vendors, collaborators and customers. It is advisable to prepare pre-scripted information bulletins, press releases or communication templates in advance and obtain internal approvals with your organization’s legal and public relations departments. Communication within your organization and with external stakeholders is critical to ensure confidence in the organization and to preserve the company’s reputation.

  • A Response and Recovery Management System

Determine in advance of an incident, the roles and responsibilities for those who will participate in the continuity and recovery processes and how the activities will be organized. An example would be the Federal Emergency Management Agency (FEMA) National Incident Management System (NIMS) Incident Command (ICS) – a nationally recognized framework used to designate responsibilities and reporting relationships during a crisis. Adoption of such a system can serve to ensure an organized and efficient response and recovery.

  • Education, Training and Testing

Employees who have a role in the BCP Program should receive education and training to implement, support and maintain the program relative to their level of involvement. Exercises with clearly defined goals such as table-top drills should be conducted at least annually to ensure that the BCP is consistent with your organization’s business continuity and recovery objectives–and that it effectively applies to likely threat scenarios. These exercises are an excellent means of education and training serving to flesh out gaps in the procedures and identify opportunities for improvement.

Exercise objectives may include:

  • Clarifying personnel roles and responsibilities
  • Obtaining participant feedback to improve or modify procedures
  • Improving coordination among internal and external teams or entities
  • Identifying and accessing resources (equipment, supplies, computer technology, personnel) needed for effective response and recovery
  • Maintaining the safety of personnel, property, operations, and the environment

All exercises should end with a debrief meeting to discuss strengths and weaknesses in BCP implementation and then followed up with an update or modification to the BCP as a result of findings from the exercise.

  • Program Maintenance and Process Improvement

The BCP should be reviewed and updated at least annually to keep pace with the growth and evolution of your organization and the continually changing threat environment. Drivers to update or modify your BCP include changes to any of the following conditions:

  • Regulations
  • Hazards and potential impacts
  • Resource availability including critical vendors and suppliers
  • Your organization (such as relocation, merger, expansion) or its operations
  • Funding changes
  • Infrastructure, including the technology environment
  • Economic and geographic stability

Establishing and maintaining a comprehensive BCP will aid biomedical and research organizations in fast and efficient response and recovery when operational disruptions arise – and help minimize the negative impacts to your staff, assets, revenue and professional reputation.

Need More Help with Your BCP?

There are several resources available to assist in developing a BCP including: International Standard ISO 22301: Societal security — Business continuity management systems — Requirements, 2012 and National Fire Protection Association NFPA 1600: Standard on Disaster/Emergency Management and Business Continuity Programs, 2013 Edition.

About the Author

Nanette Moss is a Senior Scientist with Environmental Health & Engineering, Inc. She has a Master’s of Science degree from the Harvard School of Public Health and is a Certified Industrial Hygienist with over 25 years’ experience in life science and healthcare organizations. Nanette provides expert support and guidance for the environmental health and biosafety programs at leading academic research institutions, biotechnology companies and hospitals in Massachusetts. She develops and implements plans and programs for the management of hazardous materials, pharmaceutical waste, laboratory and hospital emergency operations, bloodborne pathogen and infectious disease exposure control, biosafety and occupational health. She has also served on emergency management committees at several area hospitals.

Visit https://www.eheinc.com/ .

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Business continuity in the COVID-19 emergency: A framework of actions undertaken by world-leading companies

Alessandro margherita.

a University of Salento, Campus Ecotekne, Via Monteroni s.n., 73100 Lecce (LE), Italy

Marikka Heikkilä

b Centre for Collaborative Research (CCR), Turku School of Economics, University of Turku, Rehtorinpellonkatu 3, FI-20500 Turku, Finland

The COVID-19 emergency has urged companies to operate in new ways to face supply chain interruptions, shifts in customer demand, and risks to workforce health. The organizational ability to respond to critical contingencies is crucial for business leaders in the perspective of continuing business. In our research, we investigate the actions undertaken by 50 world-leading corporations to respond to the pandemic. Applying content analysis to web pages and social network posts, we extract 77 actions related to 13 sub-areas and integrate these into a five-level framework that encompasses operations, customer, workforce, leadership, and community-related responses. We also describe six illustrative company examples of how the emergency can generate opportunities for creating new value. The study advances the scholarly discussion on the impact of emergencies on business continuity and can help leaders define response strategies and actions in the current challenge.

1. Responding to COVID-19

Since the first months of 2020, the world has experienced an unprecedented health emergency generated by the global diffusion of a novel coronavirus (COVID-19). On March 11, 2020, the World Health Organization (WHO) declared COVID-19 a pandemic and on November 30, 2020, the WHO reported about 62 million confirmed cases and 1.5 million confirmed deaths affecting 220 countries, areas, or territories.

Besides representing extraordinary health and social emergency, the pandemic is also a major threat to companies and the continuity of their business processes. Whereas business continuity represents a strategic organizational capability ( Wong, 2009 ) also associated with resilience ( Parker & Ameen, 2018 ; Sabatino, 2016 ; Sahebjamnia et al., 2015 ; Schätter et al., 2019 ), the literature has specifically discussed the relevance of crisis management for the survival of organizations ( Laufer, 2015 ). A classification effort was also conducted to identify key research themes and trends in crisis management ( Coombs & Laufer, 2018 ) along the different pre-crisis (prevention and preparation), crisis (response), and post-crisis (learning and revision) activities ( Coombs, 2015 ).

The interest in investigating business continuity and a company’s ability to respond to a critical scenario is significantly relevant in the most recent pandemic. The difficult contingency caused by COVID-19 represents an important context to investigate company reactions. The main positioning and research goal of this article is to analyze world-leading organizations and to build a framework of responses realized by those firms to ensure business continuity in the pandemic scenario. Besides analyzing responses aimed to ensure the preservation of current value, we have a secondary focus to discuss how the emergency can generate opportunities for organizations to create new stakeholder value.

After a review of extant approaches on business continuity and organizational resilience in emergency scenarios, we present an in-depth analysis of the responses of the first 50 Fortune Global 500 companies to the COVID-19 emergency as well as a content analysis of web pages and LinkedIn posts of companies dedicated to the pandemic. Then, we discuss how we isolated 77 actions aggregated into a five-level framework that encompasses operations, customers, workforce, leadership, and community-related responses. Finally, we describe six company cases as illustrative examples of organizations attempting to create new business value in the critical scenario.

2. Background

In recent years, there has been fervent academic interest in organizational responses to critical situations. Today, organizations are forced to build resilience against numerous events that threaten the continuity of their business processes ( Sahebjamnia et al., 2018 ). These include natural events (e.g., earthquakes, hurricanes) and man-made factors such as cyberattacks, geopolitical crises and terrorism (e.g., Castillo, 2005 ; Sheffi, 2001 ), corporate crisis (e.g., Yang & Jiang, 2015 ), and market and supply chain crises (e.g., Chopra & Sodhi, 2014 ; Kleindorfer & Germaine, 2005 ; Sáenz et al., 2018 ; Strandvik et al., 2018 ). A significant stream of literature has studied the problem of planning and foresight for emergency preparedness and management ( Turoff et al., 2013 ).

Organizations strive to cope with emergencies and critical events to keep their reputation, be more resilient, and ensure continuity ( Parker & Ameen, 2018 ; Rezaei Soufi et al., 2019 ). The management of business continuity has evolved since the 1970s as a form of crisis management in response to the different risks that threaten an organization. It is a holistic management process that provides a framework for effective response ( Herbane, 2010 ), and business continuity plans have been developed primarily to minimize the effects of unanticipated events on the firm’s ability to meet customer requirements ( Zsidisin et al., 2005 ).

Scholars and practitioners have introduced several methods to assist organizations in improving business continuity (e.g., Botha & von Solms, 2004 ; British Standards Institution, 2006 ; Gibb & Buchanan, 2006 ; ISO, 2012 ; Lindström et al., 2010 ; López & Ishizaka, 2019 ). Activities include risk and impact evaluation, continuity plan/process design, implementation and measurement, testing, and continuous update of measures ( Cerullo & Cerullo, 2004 ; Pitt & Goyal, 2004 ; Speight, 2011 ). The literature emphasizes compliance with continuity standards ( Freestone & Lee, 2008 ; Tammineedi, 2010 ), risk management ( Nosworthy, 2000 ; Schätter et al., 2019 ), and organizational culture ( Alesi, 2008 ; Rapaport & Kirschenbaum, 2008 ). Typically, the focus has been on ensuring the continuity of a specific business domain such as IT infrastructure ( Bajgoric, 2006 ), supply chain ( Benyoucef & Forzley, 2007 ), or outsourcing ( De Luzuriaga, 2009 ).

With a particular focus on supply chain and business continuity, Zsidisin et al. (2005) highlighted the importance of developing business continuity plans by addressing key concepts such as risk, uncertainty, and exposure. The authors examined how and why firms create business continuity plans to manage this risk and highlighted how various isomorphic pressures left firms with similar risk management practices embedded in their supply management practices. Based on the study of companies operating in different environments, the authors found consistency in their approaches to continuity planning and four interrelated tasks (i.e., awareness, prevention, remediation, and knowledge management) that form a framework for effective continuity planning ( Zsidisin et al., 2005 ).

Whereas business continuity is generically aimed to preserve the value that an organization provides with current activities, with business model innovation the organization is deliberately altering the core elements of its model as a way to develop a new-to-business model ( Bucherer et al., 2012 ; Heikkilä et al., 2018 ; Pohle & Chapman, 2006 ). The integration between business continuity and business model was recently advanced by Niemimaa et al. (2019) , who pointed out that while business continuity focuses on preserving current operations, a crisis could also be a source of new value. Recent research also provided methods for companies to evaluate the components of their business model against future uncertainties ( Bouwman et al., 2018 ; Haaker et al., 2017 ).

There has been an increase in scholarly interest in analyzing the strategic decisions and actions undertaken by companies to respond to a crisis is increasing. Whereas the COVID-19 outbreak has generated a large stream of research contributions focusing on different managerial dimensions, a comprehensive study of company responses along several organizational perspectives has not yet been introduced. We focus on these responses in the following sections.

3. Research process

Our study involves conceptual development work based on the analysis of available web-based information about the responses of leading corporations to the COVID-19 outbreak. Content analysis is a method of studying and analyzing communication in a systematic, objective, and quantitative manner to measure variables ( Wimmer & Dominick, 2000 ). The method can be used in social science to examine patterns in communication systematically. One key advantage of using content analysis to analyze social phenomena is its noninvasive nature in contrast to simulating social experiences or collecting survey answers. Practices of content analysis range from systematic observation of texts or artifacts to which assigned labels indicate the presence of interesting, meaningful content.

Different applications of web content analysis are described in the literature. Jose and Lee (2007) used content analysis based on website disclosures to study the environmental reporting of global corporations. Ting et al. (2013) performed an advanced website evaluation to assess the top 100 hotels. Maatota et al. (2019) used content analysis of storytelling elements and brand archetypes of LinkedIn ad campaigns. McCorkindale (2010) reported on the content analysis of the Fortune 50’s Facebook social networking sites, and Parsons (2013) engaged in content analysis of official Facebook pages to assess how companies would use social media to reach consumers. The methods in these studies include a combination of sample design and preparation, source identification, analysis of content and cases, and synopsis of findings. Along with such macro research activities, our research process included three initial steps, illustrated in Figure 1 .

Figure 1

Steps of the research process

Step 1, Sample design and preparation, is dedicated to identifying the population of companies to include in the study. We looked at big corporations since they are extensively affected by the COVID-19 emergency, and they face challenges at both the local level (e.g., progression of the disease in the local communities) and the global level (e.g., impact on international markets and global logistics). The study of response strategies undertaken by these types of companies is thus more able to address a comprehensive view of the multidimensional challenges generated by a pandemic scenario.

We used the 2019 Fortune Global 500 ranking, an annual ranking of the top 500 corporations worldwide as measured by the level of their revenues. We considered the first 50 companies, which represent a well-diversified group of organizations operating in different continents and countries (e.g., China, France, Germany, Russia, Saudi Arabia, the U.K., the U.S.) and in different industries (e.g., automotive, bank and insurance, energy, food distribution, oil, telecommunication, and utilities). Companies include world-leading players such as Allianz, Amazon, Apple, AT&T, Bank of China, Berkshire Hathaway, BP, Daimler, Gazprom, General Electric, Royal Dutch Shell, Saudi Aramco, Samsung Electronics, Toyota, Verizon, and Walmart. The sources used to collect data are twofold. First, we looked at the corporate websites of companies and particularly the pages dedicated to COVID-19 and the actions undertaken by the organizations to face the pandemic. Second, we analyzed the LinkedIn pages of those organizations with a specific focus on the posts providing information on how organizations are responding to the emergency. The output of the first phase was a worksheet with the list of organizations, along with key demographic data (i.e., home country, industry, and revenues) and the web addresses of COVID-related web pages and the LinkedIn page (main profile) of the company.

Step 2, Analysis of responses and actions , focuses on capturing information on the identified companies in terms of responses to the coronavirus emergency. We studied corporate websites and LinkedIn pages to identify messages, statements, and reports on COVID-19 and on how the companies are responding along multiple perspectives. Overall, we analyzed about 300 web pages and 400 LinkedIn posts, and we annotated relevant information for further analysis and classification.

The content search was aided by the fact that practically all the analyzed organizations have set up web pages specifically dedicated to COVID-19. Concerning the LinkedIn pages, the identification of relevant content was more complex as we needed to go through all the posts from February 2020 to the time of the study (mid-April 2020) to identify information related to the outbreak and the vision and responses of the company. The content analysis process was thus not characterized by a bounded or limited sample of key concepts to be searched. More than using a priori coding schema, we conducted a systematic reading of the corporate web sources and social network messages dedicated to the emergency, and we identified three general categories of information.

First, we coded with “scenario” the general information provided by the company about the pandemic and its impact on the industry and market. The extracted content is mostly derived from the reports of the companies of what is happening in the external environment, and this was used to enhance our understanding of the business-related aspects of the coronavirus outbreak. An illustrative (adapted and anonymized) company statement is: “The COVID-19 is rapidly diffusing in most European countries, and it is creating the conditions for a limitation of flows of people and products. This could strongly impact the logistic and dynamics of our industry.”

Second, we extracted the “strategies”: general policies or approaches defined by companies to react to the outbreak. Here, the strategy refers to how the company sees the crisis and what is its position in responding to the crisis, thus providing a relevant interpretation of where the organization stands and what is the vision ahead. An illustrative statement is: “Our company intends to react firmly to the emergency by following all the indications provided by health authorities and keeping to ensure first of all the health of our workers and customers.”

Finally, we identified “initiatives” (i.e., practical activities assumed by the companies along different areas). This content was the most relevant for our study since it is explicitly related to the actions realized by the organization in response to an emergency. Naturally, the information on scenarios and strategies was relevant to better interpret the purpose and scope of those actions, as one organization illustrated with this statement: “We are extending the service period for most of our products and enhancing our contact center to provide the best service possible to our customers.”

We triangulated content gathered from the websites and social network pages by looking at corporate videos and interviews (mostly delivered by top managers), broadcasts, and other sources available on the web. We collected all relevant information into a spreadsheet for further analysis and generated a long list of initiatives (actions) realized by the 50 companies by doing a high-level consolidation of similar items.

Step 3, “Response framework building,” was aimed to obtain an integrative inventory of organizational responses. After careful analysis of extracted data, we aggregated companies’ actions by deriving a taxonomy of common macro-areas that could group similar items: operations management, customer relationship management, human resource management, leadership and change management, and community management. Most of the initiatives were clearly about one of those groups; only in a few cases were initiatives potentially relevant for two or more categories, and in those cases, we selected the most relevant dimension. We also realized a cross-check of the taxonomy with business continuity methods, approaches, and cases found in the literature. We thus obtained a COVID-19 response model, which is described in the next section.

4. Framework of response actions

This study focuses on two key concepts: business continuity (in crisis and emergency scenarios) and value creation (through business model innovation). We looked at how companies attempted to address the critical challenges caused by the pandemic event through minor or significant process changes while also looking at how business models have been adapted to create new value by leveraging the difficult contingencies.

All the 50 organizations analyzed took coordinated actions to face the COVID-19 emergency. We isolated 77 responses related to 13 sub-areas and five areas of organizational activities: (1) operations and value system; (2) customer experience and support; (3) workforce and human capital; (4) leadership and change management; and (5) community and social engagement. The classification was obtained by aggregating the single responses into homogeneous categories (sub-areas) and then identifying more high-level areas able to include those categories. Figure 2 provides a snapshot of the five areas and the 13 sub-areas of actions undertaken by companies in response to the COVID-19 emergency. All the areas are detailed through the description of the sub-areas and the illustration of the specific actions.

Figure 2

A framework of response actions for COVID-19

4.1. Actions related to operations and value system

The first area of responses is related to the effects of COVID-19 on the management of the companies’ operations and value system ( Table 1 ). In particular, responses can be associated with three sub-areas according to their focus. Some actions are addressed to face the shifts in customer demand and the impact on the supply chain, which has brought companies to identify and measure risks, and to envision a possible future. Most companies analyzed were engaged in assessing the overall impact of the crisis on operations, as well as in defining scenarios of demand and sales evolution, also based on the use of advanced analytics and business intelligence systems. Different companies, such as AmerisourceBergen, have monitored inventory levels and customer purchasing behavior to assess any potential impact on the product supply chain.

Sub-areas and actions related to operations and value system

The second sub-area of actions is related to logistic flows, both inflows of resources and materials and outflows of products and services to customers. In this case, company responses are addressed to enhance digital connectivity across the supply chain while ensuring business-critical resources, processes, and services. Also, the inventory/warehousing and order management processes are being re-engineered to optimize routes and to reduce risks. As an illustrative example, Amazon has reported realizing more than 150 process updates to ensure the reduction of risks and enhance the ability to satisfy prioritized needs.

The third sub-area includes actions related to the continuity of manufacturing processes and/or the conversion of the same to address new market needs or to contribute to the community’s fight against the pandemic. Actions included the conversion of production to deliver protective materials and products, the optimization of production capacity, and the reconfiguration of plants to enhance workforce security. In such a view, companies like General Motors have engaged in the production of protection devices (like face masks) and collaborated with partners to provide pulmonary ventilators. Whereas supply chain management generally includes logistics and manufacturing, we separated the three concepts in our framework. Based on the analyzed responses, we needed to isolate actions generically addressed to assess the supply chain impact of the crisis (thus including an ecosystem view) from more specific actions targeted at redesigning logistic and transformation activities, which are mostly related to an internal view of the organization.

4.2. Actions related to customer experience and support

A large number of response actions found in the study address the impact of COVID-19 on the customer experience and the management of the customer life cycle ( Table 2 ). The first sub-area of actions concerns the customers’ buying experience, including the buying process, with a specific focus on touchpoints and physical interaction with the company. Most organizations have reengineered access to shops and facilities and adopted several prevention measures across all customer touchpoints. Digital channels and contact centers have been enhanced, and customer mobility was assessed and reported. Companies like Walmart have taken actions aimed to limit customer access and flows in shops (e.g., one-door entry), implement sanitation and social distancing, and provide sneeze guards in all stores. Companies have also provided payment relief and financial assistance to customers along with other kinds of support services.

Sub-areas and actions related to customer experience and support

Response actions have included the development of new training for customer teams, new forms of customer outreach and communication, and emotional support to customers. For example, AT&T has provided digital parenting solutions for families. The company’s ScreenReady site shares digital parenting tips and resources to help families stay connected, learning, and entertained at home during the coronavirus. Finally, several actions are addressed to respond to the marketing impact of COVID-19. Responses included the redefinition of brand strategies and the design of new purposeful payoffs, logos, and marketing messages. In this regard, Volkswagen and Audi have temporarily modified their well-known logos to communicate the importance of practicing social distancing.

4.3. Actions related to workforce and human capital

The third response area ensures the well-being of the workforce and to reducing the negative effects of the outbreak while creating the conditions for enhancing the human capital of the organization ( Table 3 ). First, actions aim to ensure the safety of workplaces (e.g., offices, shops, facilities) by activating infection prevention measures. Responses include the definition of procedures for workplace hygiene and sanitization, rules for office layout and usage, the launch of employee-dedicated COVID-19 information portals, and the sharing of norms for physical interaction and employee tracking. For example, Hon Hai Precision Industry has used infrared scanning, severe social distancing measures in the workplace, and QR codes for employee tracking.

Sub-areas and actions related to workforce and human capital

Second, responses seek to support employee productivity, although in a smart and remote configuration. Organizations have taken actions to cope with employee infodemic (i.e., an overload of information, both online and offline) and disinformation, and they have defined criteria for workplace rotation, remote access, and competence development. As is the case with many other organizations, Trafigura Group has activated a social-spacing policy, including for office-based employees working from home. Finally, some actions focus on monitoring and managing cases of exposed and infected employees, defining leave and return-to-work procedures, and ensuring health assistance and psychological support. For example, Costco Wholesale has activated premium pay and paid time off for higher-risk employees and ensured the availability of protective masks and symptom screenings for employees and managers.

4.4. Actions related to leadership and change management

The fourth area of responses to face the COVID-19 emergency concerns actions focused on managing the current emergency while preparing the organization for the future ( Table 4 ). First, analyzed actions include the definition of a response plan and a dedicated management team, the creation of an emergency coordination task force, and the undertaking of stress tests to assess the working capital and resource preparedness of the organization. Verizon Communications has gathered purposeful senior crisis leadership and response teams able to face the emergency by identifying proper strategies and actions. Second, responses include the alignment of business leaders in terms of the organization’s strategy against the emergency, the definition of a portfolio of post-emergency actions and value-creation opportunities, and efforts to maintain the trust of people. For example, companies such as Honda Motors have put extra effort into their marketing and social media presence to enhance positive communication and encouragement for customers and the larger community.

Sub-areas and actions related to leadership and change management

4.5. Actions related to community and social engagement

The response area is related to the interaction of the organization with external stakeholders, both to contribute tangibly to fight the pandemic and by sharing knowledge useful to support first responders and the whole community ( Table 5 ). The first sub-area relates to money donations, financial support, and the provision of resources and products (e.g., protection masks, ventilators) to fight the pandemic. Actions include the provision of special discounts and gift programs to responders/helpers, contributions to open innovation initiatives by disclosing knowledge and intellectual property, and support to research entities. For example, BP has provided donations, free fuel, free delivery of food, and convenience goods to customers and partners.

Sub-areas and actions related to community and social engagement

Second, actions are addressed to ensure coordination with agencies and institutions and to share best practices and organizational experience, which can be useful for the community. Initiatives include the sharing of critical information and response tactics with responders, as well as the strengthening of public and private collaborations to define more effective response strategies. For example, Alphabet (the holding company including Google) is strongly engaged in assisting educational institutions with content, tools, and distance learning, and it has planned to launch a national platform to educate the community on coronavirus.

In this section, we have presented a comprehensive inventory of 77 response actions undertaken by 50 big corporations to the COVID-19 emergency, and we have aggregated the actions into a five-level business continuity framework. The next section discusses how the current emergency can also generate opportunities for creating new value.

5. Creating value beyond the crisis

5.1. drivers of value creation.

The literature on company behavior during recessions shows how companies can survive and even profit by modifying their marketing strategy ( Köksal & Özgül, 2007 ), increasing the R&D budget ( Laperche et al., 2011 ), investing in innovation ( Archibugi et al., 2013 ; Paunov, 2012 ), and enhancing their corporate governance ( Villanueva-Villar et al., 2016 ). The business crisis generated by the COVID-19 outbreak has also generated opportunities for organizations to go beyond simple business continuity and the preservation of current value.

A combination of transforming customer and supply chain trends and the necessary redesign of corporate processes has indeed stimulated the redefinition of strategies and actions able to generate new business value. Whereas some of the responses provided by organizations to the COVID-19 are mostly reactions critical for survival (e.g., protection of employee safety), others can be considered more transformational actions. These are aimed at developing new capabilities to respond to the current challenges while looking at the challenges as opportunities for future growth (e.g., digital health assistance and smart working).

We proceeded with a more in-depth analysis of our research data to identify interesting examples of initiatives, processes, or projects where the organizations are creating new value from a medium- and long-term perspective. Whereas new value can be generated by leveraging each element in the response framework ( Figure 2 ), the innovation potential seems to be related especially to three elements: (1) new products/services to address new customer needs; (2) improvement of virtual interaction and integration with customers; and (3) an enhanced image of the corporation as a socially responsible and community-oriented organization. Next, we illustrate these three value-creation avenues by providing six company examples.

Toyota started to face the COVID-19 emergency soon after its president announced the transformation of the company’s business model for the CASE era (Connected, Autonomous, Shared, Electric) and the evolution of the organization toward a mobility company that provides resources and services for a connected city. Whereas the company has decreased its production due to COVID-19, Toyota has maintained employment and increased investment in the R&D of electric cars. It was able to create new customer-related value by introducing new car models to the market and by improving virtual interaction with customers who can explore and make purchases in virtual showrooms via WhatsApp video, Facebook Live, web chat, or phone. The company has adopted a product- and customer-centric view, which looks at the after-emergency in terms of new societal and market needs. Toyota has provided value to the community by full-scale production of medical devices and by offering Japan Taxi models to transport patients with mild symptoms. Also, the company has cooperated in the production of equipment such as makeshift beds for hospitals, disinfectant containers, and simple partition walls for use at medical facilities.

BP has robust business continuity plans in place to make sure that the company can supply energy, fuel, and vital petrochemical feedstocks uninterrupted. In retail sites, BP has increased cleaning procedures and encouraged customers to practice social distancing while also taking precautionary measures such as removing the sale of open food products. BP has also undertaken socially responsible initiatives by supporting governments and partners with donations and free fuel to emergency services vehicles, such as ambulances and helicopters. Working with the U.S. government, leading universities, and high-tech companies, BP’s Center for High-Performance Computing has been used for research on COVID-19. These new collaborations have provided the basis for strategic renewal and a new paradigm of extended collaboration (with countries, cities, and industries) aimed at creating new value.

Amazon has updated 150 processes, from social distancing measures to new efforts like disinfectant spraying and temperature checks. It established a $25 million relief fund for its partners (e.g., delivery drivers) facing financial hardship or quarantine. To address increased customer demand , the company has focused on fast delivery of high-priority items, such as household staples and medical supplies. Amazon has provided the option of unattended delivery and defined a system to prevent price gouging. The company has also addressed the needs of customers and looked at the current situation as an opportunity to create value with new services. To help communities around the world, Amazon has made donations and provided work to 175,000 additional people. Finally, it launched a global initiative with participation from 35 global research institutions, startups, and businesses to accelerate COVID-19 diagnostics, research, and testing.

The change in insurance firm AXA’s business profile due to the pandemic has been notable. The company started providing its customers with apps for video medical consulting and new processes for online incident communication. It has also reached new customer segments. For example, AXA collaborated with the Accor hotel chain, which offered its customers free access to AXA’s medical teleconsultations from hotel rooms. Moreover, AXA has invested heavily in R&D. It provided €5 million for research to develop responses to infectious diseases, and notably to COVID-19, including the building of post-crisis solutions. The company has also supported the COVID-19 task force launched by the Institut Pasteur to develop new diagnostic tools and treatments. AXA supported an open research initiative in which a digital platform brings together engineers, practitioners, and researchers collaborating to design, test, and provide efficient emergency solutions.

The drug wholesale company AmerisourceBergen has increased inventory on items related to COVID-19 treatment and supportive care. The company has business continuity plans that include monitoring inventory levels and customer purchasing behavior for any potential impact on the product supply chain. General Electric, and in particular GE Healthcare, developed a new product, the Venue Go ultrasound system, which includes an artificial intelligence feature, the auto B-lines tool, that highlights and counts B-lines, which may signal COVID-19. The tool provides a lung diagram and generates a lung ultrasound score that helps clinicians to follow the progression of the lung condition in patients as they fight the virus.

6. Discussion

6.1. highlights and contribution.

This study has contributed to the extant business continuity literature by introducing an empirically derived inventory of response actions taken by leading companies during the COVID-19 crisis. The framework includes five dimensions, which are divided further into sub-areas and actions that address operational aspects affected by the outbreak. The dimensions range from internal operations to supply chain management, from human resources and leadership to relations with customers and stakeholders. We also include a community and social engagement perspective, which is not typically considered in the business model literature (e.g., Osterwalder & Pigneur, 2010 ). This finding shows that, at least in exceptional circumstances, the relations between a company and its local community are an important part of the company’s activities and value-creation potential.

Although many articles have depicted company responses to critical emergencies (e.g., Alesi, 2008 ; Castillo, 2005 ), we contributed with a comprehensive and evidence-based analysis of actual responses by large organizations to face the pandemic. Additionally, whereas emergency and business continuity studies have focused on general and crisis-independent activities such as risks and impact evaluation, continuity plan/process design, implementation, and measurement (e.g., Cerullo & Cerullo, 2004 ; Pitt & Goyal, 2004 ; Speight, 2011 ), we identified specific fine-grained actions aimed to ensure the continuity of business operations over a large spectrum of management dimensions.

Finally, the contribution of our study may be found in the integration between business continuity and business model innovation for value creation ( Bouwman et al., 2018 ; Foster & Dye, 2005 ; Haaker et al., 2017 ; Niemimaa et al., 2019 ). All large corporations have acted to ensure the continuity of their current business operations. However, as our illustrative cases show, some companies are also able to create new value by reaching current and new customers via digital channels, redirecting more resources from current operations to R&D activities, or increasing the companies’ social responsibility and involvement with their local communities.

6.2. Managerial insights

Some insights can be derived that could be useful for application in other companies dealing with the consequences of COVID-19 or thinking about improving their response strategies for future (likely although undesired) events. In the area of emergency management and crisis response, key success factors have been discussed in the literature, including adaptability, agility, communication, coordination, leadership, and technology application (e.g., Harrald, 2006 ; Zhou et al., 2017 ). We found these aspects in the investigated companies and their responses to the crisis and used them to formulate four main recommendations.

  • 1. Companies have been urged to develop an immediate reaction to the operational breakdown and the risks of infection within and outside the organization. Successful answers have been based on the implementation of agile business processes (which has involved redesign or adaptation of existing activities) and the use of digital technologies as key enablers.
  • 2. Most organizations have been forced to rely on available crisis management capabilities and financial and technical assets useful to face and overcome the emergency. Successful responses thus have also been based on the existence of technical reserves useful to ensure the sustainability of operations in the transition phase and to support smooth adaptation of the organization to the changing business situation.
  • 3. Organizations have developed a real-time awareness of the impact of the pandemic through advanced data gathering and monitoring capabilities. Successful responses have been based on the adoption of effective business analytics methods and tools that support information-rich communication and leadership.
  • 4. Organizations have been challenged with risks of declining sales due to switching customer needs and demand. Successful responses have included the creation of diversified and modular product/service portfolios and adaptable business models that can support a faster recovery.

7. Concluding remarks

In this study, we investigated the responses of 50 world-leading companies to the COVID-19 emergency, and we integrated the responses into a descriptive framework. To the best of our knowledge, this study is the most extended attempt to build an inventory of real actions undertaken by large companies to deal with a common global emergency.

The research is not without limitations. First, business continuity has been historically associated with medium and large corporations, and our research also focused on big organizations. However, the concepts of business continuity and resilience against emergencies should be extended to small organizations, which face the crisis generated by the pandemic along different and equally significant dimensions. Second, we used data available online (web pages and social network posts), which is the information shared by organizations about their responses to COVID-19. However, such public information is not necessarily able to describe the policies defined and actions undertaken by the companies comprehensively. At the same time, corporate communications messages conveyed through public outlets like websites and social network posts may be biased as possibly self-serving statements, which might not represent the situation with either accuracy or comprehensiveness. Access to real company knowledge and objective analytical reports, where possible, would thus allow researchers to strengthen the model by adding more fine-grained actions implemented by managers.

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Business Continuity Solutions and Challenges in Clinical Research

Business Continuity Solutions and Challenges in Clinical Research

Business continuity solutions provide a sustainable route to strengthening resilience and agility across clinical research and the wider pharmaceutical industry.

In a research landscape where ongoing challenges including critical skills gaps, talent shortages and digitalisation hurdles continue to disrupt timelines, actionable business continuity solutions are in high demand. Read on to discover:

Top business continuity challenges in clinical research

How to assess risk to your clinical programme.

  • Why upskilling strengthens business continuity

1. Talent acquisition and retention

Global research organisations continue to face growing laboratory technician shortages, with the UK alone requiring  an additional 700,000 technicians by 2030 .  For those organisations that do attract talent, retention poses an additional hurdle.  National Technical Development Centre Director, Natalie Kennerly,  suggests that graduates are not always ‘work-ready’ or equipped for the practical processes, and fast-paced problem-solving laboratory environments demand. Meanwhile, insufficient job classifications and an absence of clear career progression are exacerbating difficulties in retaining laboratory technicians. Few organisations are stepping up to combat these issues -  merely 39.6% of employers equip lab techs with continued education options . 

2. Skills shortages

As the wider pharmaceutical industry seeks to digitalise, drug discovery and development research is becoming increasingly high-tech, driving a need for digital skills in the laboratory,  alongside existing skills shortages.  While recent  industry analyses led by the Association of the British Pharmaceutical Industry  indicate some progress in repairing more general skills gaps across biological and chemical science, there are persisting areas of concern.  Priority skill shortages include informatics, computational, mathematical, and statistical skills – all crucial competencies for a holistic digital strategy. 

3. Increased cybersecurity risks

Cybersecurity risks are emerging alongside increases in digitalisation and pose the greatest risk of supply chain disruption across pharma. For laboratory leaders, mitigating the risk of cyberattack disruption will involve prioritising both risk and cost when building supply chain networks. McKinsey’s post-covid sector analysis  includes the following recommendations: • Consider excess capacity in the global network to enable flexibility • Increase the extent of dual sourcing • Diversify partner portfolios • Adopt near-shore or local strategies

4. Headcount restraints

Alongside the complexities of expanding and adapting the workforce to repair skill gaps and strengthen business continuity, headcount restraints often mean increasing workloads, and minimal staff on-site – a combination that can work against employee retention strategies. Alternatively you can collaborate with a scientific services business, such as  Synergy , where the costs of trained scientific and clinical technicians work at your site and fall under OPEX budgets, and not FTE expenditure, enabling laboratories to expand their personnel and maximise the potential of their laboratory’s space and equipment without the same budget concerns, or restrictions.

Agile and resilient business continuity plans start with holistic risk assessments that activate transparency across both research, and supply chains.  These risk assessments provide a nuanced view of where vulnerabilities, and opportunities lie, enabling leaders to both protect, and strengthen resource allocation and management where most relevant. 

Step 1. Identify disruptors

Identify and list the key disruptors most likely to be faced by your organisation across your critical functions and operations. These could include:

  • Cyber-attacks – Is there a clear strategy in place to protect data?
  • Supply chain issues – Are there single sourcing vulnerabilities?
  • Research participant safety – Can you ensure uninterrupted care of research participants or clinical trial patients at investigator sites?
  • Ability to work remotely – Are back-up personnel cross-trained to conduct critical tasks?
  • Monitoring if workers are offsite – Are employees sufficiently trained to conduct offsite monitoring?
  • Data integrity -  Can you assure that any unplanned reactions (e.g, medicinal transfer from clinical trial sites to patients) will be documented, scheduled and performed to standard?

Step 2.  Estimate the probability of occurrence, and the level of impact

Use risk assessment planning tools, such as a probability matrix, to reliably assess how likely disruptors are to occur, and how severe their impact would be on business continuity. Key risks likely to affect clinical laboratories include:

  • Geopolitical risks
  • Human capital and employment risks
  • Economic risks
  • Legal risks
  • Infrastructure risks

Step 3. Develop strategies for prevention

Using your findings, develop personalised strategies for prevention based on your company’s resources, and the potential impact level of occurrence on business continuity.  For those incidents that may be unavoidable, develop a resource of key mitigating measures to minimise consequences and severity of occurrence. These could include seeking additional expertise to supplement existing functions, and bolster resilience, or investing in building them internally. At  Synergy  we support clinical laboratories to expand their teams internally while avoiding employment risks and headcount limitations. This is achieved through our insourced teams receiving payment via OPEX budgets rather than FTE expenditure.

Why upskilling strengthens business continuity 

SRG’s 2022 Global Science Employment Report  reveals that the skills gap is pertinent for STEM business across the world. 64% of UK STEM workers, 67% of European STEM workers, and 71% of US STEM workers are currently experiencing a skills deficit in their workplace.  To be truly successful, business continuity plans should strengthen operating models, and their workforce in tandem, carving new avenues for professional development that align with strategic goals and secure continuity even across times of change. Shifting priorities post-pandemic are driving an increase in hybrid work even in laboratory environments.  SRG’s research  shows that most STEM employees cite a good work life balance as the most important factor for them at work. However, without appropriate frameworks in place, hybrid models of work can be challenging to accommodate in research contexts. Upskilling and cross-training teams can offer laboratory leaders a reliable way to activate more hybrid opportunities, while preserving research continuity and agility. Meanwhile, as digitalisation and automation become more commonplace in research, laboratory leaders should seek to accommodate improved professional development options for workers to both prepare for emerging skills gaps, and repair existing ones. Doing so will enable your research organisation to keep pace with competitors, and preserve continuity through new technological efficiencies, rather than being hindered by them. 

Synergy: providing business continuity solutions for clinical research

At  Synergy , we employ teams of trained scientific professionals who work alongside your staff on-site, providing flexible and agile resource support to repair skills gaps, and power business continuity.  Synergy’s business model empowers research organisations to package routine high value scientific activities into their scope of work with pre-agreed deliverables, and costs. Our technical teams are equipped with continuous lean training and additional managerial training and development, that enables them to complete routine scientific activities with little error. This frees permanent staff within your clinical business to redirect their attention to ROI generating activities including strategy, and complex scientific analysis, while improving their workload and likelihood for retention.

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Business Continuity Planning for Investigative Sites

Posted in Process Improvement

Do you have a business continuity plan?

business continuity plan clinical research

Since March 2020, there has been a worldwide pandemic, fires in California, power outages in Texas and, most recently, war in Ukraine. In the latter case, sponsors will need to adjust the ways clinical trials are run in that region and deal with the impact of protocol deviations and other consequences of the disruption. To address that need, EMA has issued advice to sponsors on managing the impact of war in Ukraine on clinical trials. It can be accessed here:   Advice to sponsors on managing the impact of the war in Ukraine on clinical trials | European Medicines Agency (europa.eu)

Uncertainty about what might happen, whether it is a natural disaster, a pandemic, or a geopolitical event, does not mean you have to be unprepared. To address any kind of significant business disruption, you should have a business continuity plan in place.

In the life sciences industry, we encourage sites to be inspection ready. In the same vein, having a business continuity plan is good business practice. ICH E6 Section 4.12 requires that if a trial is prematurely ended or suspended for any reason , the investigator should assure appropriate therapy and follow up. Conducting a Business Impact Analysis and having a Business Continuity Plan provides assurance to Sponsors, CROs and your study participants that you are prepared to manage any significant disruptions to the business.

Conducting a Business Impact Analysis (BIA)

A BIA provides a systematic approach for analyzing the impact of a disruption on the critical functions of the business, what resources will be required to continue operations, and your recovery time objectives.

Consider what resources will be needed to put contingency arrangements in place. This might include:

  • Ensuring staff have the ability (and equipment) to work from home
  • Contracting with a staffing agency to supply staff if your own staff must quarantine
  • Ensuring all essential staff have external batteries, power banks and cables if power is lost

When doing the impact assessment, it is helpful to think of the impact over time and consider key deliverables, e.g., supply of study medication and collection and reporting of safety and endpoint data. For example, 3 hours, 1 day, 3 days, 1 week, 1 month. In guidance issued by FDA , Sponsors are encouraged to consider flexibility in visit windows along with the use of electronic communications, including social media platforms, and mobile medical professionals such as nurses and phlebotomists, to reduce the burden of trial participation for patients. Similarly, MHRA in their Risk-Adapted Approach to Clinical Trials and Risk Assessments guidance , has encouraged sponsors and clinical service providers to build flexibility into protocols, SOPs, and risk assessments to lessen the impact of a disruption.

Once you have all that information compiled, plan to review it periodically and update it, as necessary. When and if a disruption occurs, that is the information you will use to populate your Business Continuity Plan.

A Business Continuity Plan (BCP)

The purpose of the Business Continuity Plan is threefold:

  • To respond to the disruptive incident, i.e., incident management
  • Maintain delivery of critical activities or services (business continuity)
  • Return to business as usual (recovery and resumption)

All staff, as part of their on-boarding training, should be made aware that in the event of an incident, there is a plan in place to manage incidents and restore business operations as soon as possible. They should be encouraged to keep their personal contact details up to date and, if assigned a role as part of the business recovery process, be trained on their responsibilities.

It is good practice to have a business continuity team identified in the BCP. They should all be alerted once the plan is activated.

The purpose of the incident management phase is to protect the safety of patients and staff, protect vital assets, ensure necessary communication takes place, support business continuity (e.g., conduct study visits via telemedicine), and support the Recovery and Resumption phase.

Actions To Support Business Continuity

Actions to support business continuity include recovery of vital assets and equipment so business can continue, determining key priorities, letting staff know what is required of them, publicizing interim arrangements so clients and study participants know the contingency plans, and keeping an incident log to document decisions made and actions taken and, last but not least, keeping a record of expenditures made.

Depending on the incident, each study protocol and the schedule of procedures should be evaluated, as should the individual participants’ circumstances.

Actions To Support Recovery and Resumption

The purpose of the Recovery and Resumption Phase is to resume normal working practices for the team. Where the impact of the incident is prolonged, normal operations may need to be delivered under new circumstances, e.g., from a different building, remotely or even from a different country. You should conduct a debrief and ‘lessons learned ‘and get the word out that ‘business as usual has resumed’.

The WCG Avoca Quality Consortium (AQC) develops leading practice tools and templates based on subject matter expertise and collaboration including AQC Leadership Advisory Boards (LABs) comprised of AQC Member representatives who advise on and review AQC workstream developments. AQC Members can access a  Business Impact Analysis Template  and a  Business Continuity Plan Template  developed by the Site Quality LAB in response to the pandemic, which can be tailored for any type of disruption.

Learn more about becoming a Member of the AQC to access over 1,000 leading practices and metrics that you can use to help you prepare. Contact Us

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Brigid Flanagan, BA, RN, CCRC, MSB

Senior Consultant

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Emergency Management

Business continuity for clinical practices.

Clinical practices are vital to the health and wellbeing of both the University and the countless individuals that seek treatment and care. Disasters and other emergencies can threaten a health care organization’s ability to maintain operations and provide services. Whether it is a major disaster or a localized incident, patient care can suffer. It is vital that clinical practices be prepared to address the unique needs of their operations regardless of the disaster. A business continuity plan will help minimize and possibly even prevent serious consequences and down time following a disaster or major disruption. Watch the video below for more information about the value of business continuity planning for clinical practices.

Business Continuity Planning Guide

  • Guide to Business Continuity Planning for Clinical Practices

Business Continuity Planning Worksheets

  • Important Contacts
  • Essential Functions + Business Impact Analysis
  • Specialized Supplies
  • Essential Vendors
  • Specialized Equipment
  • Vital Documents
  • Drives, Files, Folders
  • Minimum Site Requirements
  • Alternate Site Information
  • Recovery Planning
  • Mitigation/Follow-Up Actions

Business Continuity Planning: Ensure Your Laboratory is Prepared for a Crisis

business continuity plan clinical research

It is not a matter of if disasters will occur, but when will they occur. According to the Business Continuity Institute – 2019 Horizon Scan Report the top five threats of greatest concern for 2020 are:

  • Cyber-attack or data breach
  • IT and telecom outage
  • Adverse weather or natural disaster
  • Critical infrastructure failure (e.g. power disruption)
  • Reputation incident (e.g. product quality problem or recall)

Other top threats include staff shortages, regulatory changes and supply-chain disruptions.

All institutions are at risk; however, the research and commercial laboratory environment presents unique risk management challenges. Laboratory centered organizations have significant funds invested in research materials, laboratory animals, specialized equipment and environmental controls. Examples of disruptions to research can include loss of biological samples and research animals as a result of power outages or flooding. It is vital that laboratories have an effective business continuity plan for protecting these assets and for minimizing disruption and potential financial loss in the event of a disaster.

What is Business Continuity Planning?

Creating and maintaining a business continuity plan (BCP) helps ensure that an organization has the resources and information needed to deal with emergencies. This goes beyond the scope of an OSHA mandated Emergency Action Plan. The scope of a BCP typically includes the entire organization (including multiple sites), applies to all forms of emergencies and has a long-term focus on the continuation of essential operations for protection of not only personnel and property but also research assets (e.g. biological materials and laboratory animals), products, reputation and investments. Business continuity planning comprises the steps, policies and procedures that are activated once a disaster has occurred. The objective is to ensure that critical services or products are delivered during a disruption and to recover as quickly as possible to minimize downtime and financial loss.

Laboratory Environment Presents Unique Challenges

Research and commercial laboratory organizations face unique challenges in resiliency planning because these facilities often include large specialized equipment, vivariums, insectariums, aquatic animal housing or spaces that require continuous environmental control and monitoring. This makes it impractical or impossible to establish temporary operations at an alternative site during a long-lasting disaster. In addition, laboratories that maintain accreditations or licenses from regulatory agencies or organizations may be required to conduct their operations only in the licensed facility. That means that all possible resources must be devoted to bringing the facility back into operation as quickly as possible during or after a crisis.

In addition, specialized laboratory equipment may require use of vendor-specific consumable products and certain reagents or rare products may only be available from a single vendor or may have long lead-time constraints. Qualifying back-up vendors and off-site warehousing of these critical supplies can serve to off-set these liabilities. Preserving temperature sensitive materials, common to this industry, must be considered as power disruptions are not uncommon and emergency generators cannot always be relied upon for long-term or large-scale regional disasters. Banking or relocating critical biological materials to a cold storage biorepository can assure that these assets are protected and can be readily retrieved once operations are restored.

Staffing issues also present challenges because specialized training and qualifications are usually required to perform critical functions in a high-technology environment. These employees cannot be easily replaced in the event of a staff shortage due to situations such as epidemics and school or road closures. Some organizations might consider comprehensive cross-training programs to address these types of staffing interruptions. Another option is to temporarily relocate willing staff to alternate locations within the organization to conduct their work. This would involve logistical planning for transportation and lodging accommodations.

Finally, laboratory centered organizations require complex information technology services and support including systems to ensure data security, availability, processing integrity, confidentiality and privacy. Management systems should be developed to provide data backup, cloud storage, virtual desktop infrastructure and redundancies for internet access and other vital system components.

Key Steps in Business Continuity Planning

Risk assessment and business impact analysis.

The first step to creating a BCP is to conduct a risk assessment and business impact analysis. This is essentially the foundation for a comprehensive BCP. It involves identifying the types of threats that may impact the organization (e.g., hurricane, cyber-attack, supply-chain disruption) and estimating the probability of an occurrence and the severity of the impact. It will help you to develop strategies for preventing serious incidents that could compromise the facility and its operations, as well as to develop mitigation measures to minimize the consequences and severity of incidents that cannot be prevented.

Questions a laboratory organization must address include:

  • What are our critical functions and operations?
  • What are our essential assets? For example, in vivo animal models, transgenic animals, cell lines, primary tissue, genetically engineered vectors, compound libraries, scientific and/or clinical data.
  • Who are the key personnel and vendors?
  • Where are our vulnerabilities? This could include single-source suppliers, facility location in a flood zone, only one emergency generator, etc.
  • What resources are needed for recovery? For example, staff, supplies, equipment, facility, utility systems, technology, finances and vital records.

Next, estimate the consequences or impact resulting from recovery delays such as loss of revenue, customers, company reputation, products or investments. Develop and implement prevention and mitigation measures to off-set the vulnerabilities.

Involve Key Stakeholders

An important factor to successful business continuity planning is ensuring that you have included all the relevant stakeholders in the planning process and in developing the written business continuity plan. This helps ensure that all research operations are taken into account when developing the business continuity plan. In a research environment this can include personnel such as:

  • Scientific research community
  • Vivarium operations personnel
  • Facility operations personnel
  • Environmental health and safety professionals
  • Human resources
  • Information technology

Communications

  • Purchasing/Procurement

Recovery Objectives, Strategies, Tasks and Timeframes

Once the Risk Assessment and Business Impact Analysis are complete, you can establish and prioritize recovery objectives, strategies, tasks and timeframes. This may include relocating critical biological materials to a temperature-controlled biorepository, temporarily using a reference laboratory, relocating some operations to an academic core facility, switching production to another company site, using back-up vendors or having staff work remotely. In some situations, it may not be possible, or safe, for staff to enter the facility or there may be circumstances where staff may be unable or unwilling to come to the worksite (e.g., employees were injured, emotionally affected by the disaster, need to care for family members). If it is possible for staff to work remotely or at temporary alternate locations, it is important to ensure that technology support is available such as VPN access or remote logon capabilities.

An essential component of a BCP includes steps or procedures for internal and external communications. Employees must be notified of the emergency situation and instructed whether to come to work or stay home. These notifications can be accomplished by using mass electronic notification software systems, telephone call trees, group texts and social media platforms. Keeping employees well informed regarding situation developments and providing instructions and expectations is essential to maintain a calm and organized response to disruptions.

Communication with external organizations such as fire departments, police, public health and emergency response units is necessary to obtain critical information regarding the emergency and request assistance if necessary. Other stakeholders may need to be notified such as regulatory agencies, vendors, collaborators and customers. It is advisable to prepare pre-scripted information bulletins, press releases or communication templates in advance and obtain internal approvals with your organization’s legal and public relations departments. Communication within your organization and with external stakeholders is critical to ensure confidence in the organization and to preserve the company’s reputation.

Document and Organize

Many laboratories depend on specialized equipment and supplies. It is important to develop and maintain lists of equipment, supplies, and vendors so that the information is readily available during a crisis. Consider the needs of specialized environments, such as vivariums and aquaculture facilities. Work out specific steps and procedures such as when to activate the BCP, who will conduct the tasks and in what order; and when to return to normal operations. A recovery checklist is a useful tool to ensure that all systems are re-established and calibrated. Ensure that the following items are addressed:

  • Damaged and contaminated materials, supplies and equipment have been removed
  • All utility systems are operational including water, sanitary sewer, HVAC, gas and electric supply.
  • Equipment is calibrated; running validation samples may be required
  • Environmental control and monitoring, fire suppression, security and hazardous materials systems are restored
  • Par levels of supplies and reagents are replenished
  • IT and telecom systems are operational
  • Insurance assessments and financial impacts have been documented

A Response and Recovery Management System

Determine in advance of an incident, the roles and responsibilities for those who will participate in the continuity and recovery processes and how the activities will be organized. An example would be the Federal Emergency Management Agency (FEMA) National Incident Management System (NIMS) Incident Command (ICS) – a nationally recognized framework used to designate responsibilities and reporting relationships during a crisis. Adoption of such a system can serve to ensure an organized and efficient response and recovery.

Education, Training and Testing of the Plan

Employees who have a role in the BCP Program should receive education and training to implement, support and maintain the program relative to their level of involvement. Business continuity plans are not complete until you can demonstrate that they work. Tabletop exercises using various real-life scenarios (e.g., flood, hurricane) should be conducted at least annually to ensure that the BCP is consistent with your organization’s business continuity and recovery objectives – and that it effectively applies to likely threat scenarios. These exercises are an excellent means of education and training serving to flesh out gaps in the procedures and identify opportunities for improvement. Exercise objectives may include:

  • Clarifying personnel roles and responsibilities
  • Obtaining participant feedback to improve or modify procedures
  • Improving coordination among internal and external teams or entities
  • Identifying and accessing resources (equipment, supplies, computer technology, personnel) needed for effective response and recovery
  • Maintaining the safety of personnel, property, operations and the environment

All exercises should end with a debrief meeting to discuss strengths and weaknesses in BCP implementation including gaps in the BCP. This should be followed by an update or modification to the BCP as a result of findings from the exercise.

Program Maintenance and Process Improvement

The BCP should be reviewed by all relevant stakeholders and updated at least annually to keep pace with the growth and evolution of your organization and the continually changing threat environment. For example, emergency call lists must be updated as personnel responsibilities change in the organization. Drivers to update or modify your BCP include changes to any of the following conditions:

  • Regulations
  • Hazards and potential impacts
  • Resource availability including critical vendors and suppliers
  • Your organization (relocation, merger, expansion) or its operations
  • Infrastructure, including the technology environment
  • Economic and geographic stability

There are a number of resources available to help you get started with developing your BCP including the National Fire Protection Association (NFPA) 1600 Standard on Continuity, Emergency, and Crisis Management, 2012 and the International Organization for Standards (ISO) 22301 Security and resilience — Business continuity management systems — Requirements, 2019.

Turn a Crisis into an Opportunity

Every crisis presents an opportunity to review the effectiveness of the BCP and to determine if modifications are necessary. When the crisis has passed, the Crisis Management Team (usually comprised of key leadership position holders within an organization) should convene to assess its performance and to determine ways in which the institution’s response could be improved. For example, did the planned measures appropriately address the situation and help alleviate disruption to operations? Did personnel understand their role in implementing the measures? Is additional training needed?

Process documentation is key to evaluating the response post-incident, including a narrative of events, emergency response actions, communication efforts, receipts for costs, etc. This documentation should be maintained by an appropriate member of senior management (e.g., operations, research, environmental health and safety).

No institution is immune from the losses that can result from a crisis. Laboratory organizations need to take precautions in order to protect staff and their assets, many of which are unique and irreplaceable. The process does not end with the development of the plan. The plan must continually be reviewed and tested to ensure its effectiveness and to keep up with the ever-changing laboratory environment.

Implementing a comprehensive business continuity program will undoubtedly improve your organization through resiliency – you will be more able to quickly respond to serious disruptions while continuing operations and safeguarding staff, assets and your organization’s professional reputation.

If you need expert guidance and support to help develop – or test – your business continuity plan, contact us today!

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NCURA Online Learning

Primer on business continuity in research administration: planning, implementation, redesign and resumption.

  • Table of Contents

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This publication introduces the concept of business continuity planning (BCP), the importance of and process for developing a BCP, and the implementation of BCPs from the standpoint of different types of research institutions, including Predominantly Undergraduate Institutions (PUIs), mid-size research universities, large-scale research universities, and academic medical centers and research institutes.

Topics include: .

  • Developing a BCP 
  • Key business processes continuation strategies
  • BCP Implementation
  • HR/IT Considerations

(35 pages, PDF, © 2021) 

Exclusively available online. Purchase includes a BCP Template (separate file). Purchase and download the PDFs. Once purchased both PDFs will be available for download for 30 days. To purchase click the “Register” button.

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Andrew Chase Vice President of Research Management and Finance Mass General Brigham Healthcare System

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Louise Griffin Senior Director for Research Administration and Compliance University of New Hampshire

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Kristen Harding Research Compliance Officer, Faculty of Arts and Sciences and School of Engineering Harvard University

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Kris Monahan Director, Sponsored Programs and Research Compliance Providence College

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Jill Mortali Director, Office of Sponsored Projects Dartmouth College

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Ara Tahmassian Chief Research Compliance Officer Harvard University

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How the World’s Leading Vaccine Site Network Decreased Protocol Deviations by Almost 40%

Overview With 9 locations in Texas, California and Louisiana, Benchmark Research is the world’s leading vaccine network. Benchmark has performed over 10,000 studies on over 40,000 subjects and has received numerous awards, including being a five-time recipient of the Best Clinical Trial Site/Network award from the World Vaccine Congress. Challenge Historically, Benchmark used paper charts...

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Ask Me Anything – Hitting the Target with Good Study Design

Mary Brenner, MSN MArch RN, is CRIO’s Study Design Manager and brings deep-rooted expertise as a registered nurse to CRIO’s in-house study design team. In this quick Q&A, Mary shares the benefits of good study design for sponsors and sites, the downstream effects of standardized study designs, and gives tips for designing it on your...

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Key Takeaways from the 2021 SCRS Site Solutions Summit

Reflections on the Summit The 2021 Global Site Solutions Summit, hosted by the Society for Clinical Research Sites, was an amazing event. The first in-person event that our company has attended in 18 months, the Summit provided an opportunity for CRIO to meet new people and reconnect with clients and friends alike. Post-Pandemic Trends, Here...

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Technology Innovation in Clinical Trials is Here to Stay

The staying power of technology after the pandemic  The clinical trials industry has historically been slow to adopt innovation, but 2020 was a catalyst for transformation. Spurred on by the need for business continuity during the pandemic, sites and sponsors worldwide were highly motivated to reconsider business as usual, and many have adopted an array...

business continuity plan clinical research

Business Continuity Plan for Clinical Trial Sites: Why Electronic Source Matters During COVID-19

The impact of COVID-19 on clinical trials has likely become obvious for your site during this phase of the pandemic. Sites are struggling with screening holds, limited staff, an influx of sponsor requests while staff is not on-site, the challenge of retaining enrolled subjects, and more. It is now more important than ever to implement a business...

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Business Continuity Plan - Pandemic

On this page, what is a business continuity plan, is a pandemic plan different than a regular business continuity or resumption plan, how many people will be away from the workplace during a pandemic, what are some effects of a pandemic on a business, how do you set priorities for your plan, what are elements that should be included in a business continuity plan for pandemics, using an office setting as an example, how can the office space accommodate physical distancing requirements, what are other good practices to help reduce the spread of infectious diseases, what should we be aware of for covid-19 symptoms.

A business continuity plan is a document that outlines how an organization will continue to function during and after an emergency or event. It involves planning how your key services or products can continue.

Please remember... each business is unique – the topics listed in this document are general suggestions. You will need to create a specific plan that best suits your business and operational needs.

This document focuses on creating a business plan for infectious diseases such as a pandemic or severe seasonal outbreak that results from a virus or other agent. It is intended for non-health care organizations. Health care organizations, as well as other first response agencies (e.g., police, emergency, first aid, ambulance) will require more rigorous infection control measures, and workforce plans.

Please see the OSH Answers "Emergency Planning" for information on a general emergency response plan.

In some ways, yes.

Traditionally, most business continuity plans focus on what will happen if the building or equipment is damaged. In other scenarios, the plan may assume that people will be able to return to a building after a single event (such as after a storm, or if there is a utility outage).

However, if there is a serious infectious disease outbreak, such as a pandemic, you must plan for the workers being unable to report to work for a period of time. During a pandemic, businesses, social organizations, or schools may be required to close by order of health officials to help slow the spread of the illness. These steps will influence how many people may be available to report to work. Other measures may be enacted by governments or recommended by public health officials, such as physical distancing, hand hygiene, travel restrictions, limits to the number of people who can gather at a single location, alternative, use of non-medical masks, etc.

It is important to plan to have your core business activities to remain operational for several weeks or months with limited staff like working remotely.

Please see the booklet  Business Continuity Plan: Infectious Diseases  for more information.

It is hard to say with certainty. Every pandemic is different. It will depend on the virus's “viral ability” – that is, how easily the virus spreads and how sick people become. Workers may be away from work for various reasons (e.g., illness, caregiving, school closure).

Also note, as stated by the Government of Canada: “The pattern of disease is different in pandemics than in seasonal influenza. Pandemics may arrive outside of the usual influenza season and typically have more than one wave of illness. The total duration of a pandemic is likely to be 12 to 18 months.”

It will be important to make sure your plan will accommodate staff absences for more than a single period of time.

Possible effects on business from a pandemic can include:

  • reduced labour supply, including your regular workers or availability of contractors or temporary workers
  • reduced business or cancelled customer orders
  • interruption in getting supplies or materials (especially if goods are imported by air or land)
  • change in demands (for example: increased internet use, decreased tourism/travel, alternative methods to conduct business such as curbside pick up, or delivery)
  • reductions or restrictions on public meetings or gatherings (including schools, sports, clubs, theatre, community centres, restaurants, religious gatherings, etc.)
  • restrictions on travel (regional, national, or international)
  • reduced availability of health care or home care services
  • reduced availability of child day care services
  • in more severe situations, disruptions in services such as telecommunications, financial/banking, water, electricity, gasoline/fuels, medicine, or the food supply

In general, when creating a business continuity plan, determine what element is critical and how the loss of this element will affect the business.

  • Identify critical processes, operations, and functions.
  • Identify key internal and external dependencies – those things, people, or other business you rely on.
  • Identify what else can affect your business.

When planning for your priorities, examine:

  • Personnel – Identify and train back ups for essential functions, including chain of command (management). Be sure you have consulted with staff, including any applicable union or collective agreements.
  • Equipment – Make sure the available equipment meets the identified needs.
  • Availability of assets – Make sure that facilities, utilities, computers, machinery, or tools also meet your needs (e.g., access to internal systems by staff working from home).
  • Business commitments – Research legal implications for level of service arrangements (e.g., for non-performance or late delivery).
  • Accounting – make sure you can continue your payroll, finances, etc.

Elements of a risk assessment process may also be helpful.

How detailed your plan is will depend on the type of business, how complex your organization is, and its size. Allow your plan to be flexible and proportional to match the level of threat that is occurring at that time. As a pandemic evolves, restrictions may be lifted or tightened, as determined by local public health officials. It may also be the case that certain geographical areas have different levels of measures in place. Your plan should include health, safety, human resources, and management elements.

Options include:

  • Document guidelines for management and business decisions – remember, anyone can get sick.
  • Create a pandemic management team that assigns who will do what tasks, establishes chain of command, coordinates prevention activities, etc.
  • Make decisions about when to stay open, when to close to customers, when to use alternative methods to conduct business, and when to close completely.
  • Assign a person or team, where appropriate, to help assess the health of workers (e.g., if the worker may be coming down with an illness) such as by using screening checklists as provided by public health officials.
  • Cross train workers to make sure essential functions will continue (e.g., payroll, customer service).
  • Provide handwashing facilities and/or alcohol-based hand sanitizers (of at least 60% alcohol).
  • Have a period of time between shifts to clean touch points and surfaces such as tables, door knobs, hand rails, shared telephones and keyboards.
  • Have up-to-date sick leave policies. NOTE: Be aware that doctors may have limited availability to provide sick-leave documentation.
  • Maintain an up-to-date list of your staff and your clients (e.g., telephone trees, call-in numbers, hot lines for information, broadcast e-mails)
  • Develop communication methods to reach all staff, especially if staff are working remotely.
  • Develop methods to conduct your business, including using the internet, cloud-based workspaces, phone, video conferencing, etc.
  • Develop methods that allow workers to use flexible work options, or telework/work remotely.
  • Increase the distance between people (e.g., install a protective barrier for those working with the public, increase the distance between workstations, use larger meeting rooms, limit the number of users in a common area such as a lunch room or washroom).
  • Consider providing transportation for those staff that use public transportation.
  • Consider psychosocial issues (e.g., financial stress, caregiver burnout, occupational stresses, stigma, or social exclusion).
  • Consider postponing or cancelling face-to-face meetings (including internally) as well as unnecessary travel.
  • Create small working groups or "cohorts" (e.g., a factory may keep the same group of people together on the same shifts).
  • Document which workers were present each day to assist public health with contract tracing if a case is discovered.

There are three key areas to consider:

  • the space and equipment an individual uses
  • the common use spaces, such as meeting areas, social areas, lunch rooms, equipment rooms, as well as the paths of travel
  • personal measures, such as hand hygiene and respiratory etiquette

The workplace should evaluate who needs to be in the office, and how they will function in the space. It may not be possible to allow your normal capacity of people in the building and maintain physical distancing at the same time. Additional factors include “congestion points” such as kitchens, lockers, closets, elevators, stairs, washrooms, and emergency exits.

Public Services and Procurement Canada (2020) have developed a " Guidance and practices for the safe return to workplaces in light of the easing restrictions " document. When assessing the workstation layout, be sure to measure for 2 metres distance in all directions, measured from where the individual would sit.

Public Services and Procurement Canada note that "there is no evidence that partitions provide sufficient safety between occupants, and should not be the first line of defence". Maintaining 2 metres physical distance is preferred. When considering additional partitions or other barriers, also determine if the installation will reduce the effectiveness of the ventilation systems.

Staggered seating or re-arrangement of desks may help. Face-to-face seating is discouraged.

Other measures may include:

  • making sure the ventilation system is working appropriately. Increase air refreshment rates, if possible.
  • allowing workers to work at the same desk each day if seating arrangements would normally be flexible
  • asking workers to maintain a tidy desk to assist with cleaning and disinfecting
  • removing extra chairs from meeting rooms to help avoid over crowding
  • using wide tables when individuals are sitting face-to face
  • keeping doors open to assist with air circulation
  • indicating path of travel in hallways, especially if the hall will not allow persons to pass and maintain physical distancing
  • labelling doors as entry or exit only
  • allowing only 1 person in an equipment room or kitchen at a time
  • if allowing the use of microwaves, fridges, etc in the office, providing a method to clean the surfaces after use
  • waiting until the other person has left before approaching a locker or coat closet
  • marking spots outside meeting rooms or washrooms where people should wait before entering
  • allowing time between meetings to allow for the air in the room to refresh

Good health habits are important in preventing the spread of infectious diseases. Steps to take include:

  • maintain physical distancing of 2 metres
  • frequent hand washing with soap and water
  • using alcohol-based hand sanitizers (at least 60% alcohol) when soap and water are not available
  • avoiding close contact with sick people
  • coughing and sneezing into your elbow, or use a tissue (and throw away the tissue immediately)
  • avoiding touching your eyes, nose and mouth
  • using good hygiene practices , such as cleaning and disinfecting surfaces likely to be contaminated and touched by others, or practicing physical (social) distancing (e.g., keeping 2 metres between individuals, using teleconferencing or remote work technology)

In general, people should be encouraged to stay home if they are ill (even if the symptoms are mild), or if they think they are ill . Allow time for complete recovery and a healthy return to work.

When a person is infected with COVID-19, they may have little or no symptoms, and the symptoms they do show can be easily confused with a cold or seasonal flu.

COVID-19 appears to mainly spread from person-to-person when people are in close contact with one another (within about 2 metres or 6 feet) and through respiratory droplets produced when a person coughs or sneezes. These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.

It is possible that it can spread from contact with infected surfaces or objects – when you touch a surface or object that has the virus on it and then touch their own mouth, nose, or eyes.

Note that Government of Canada states that there is evidence which indicates that the virus can be transmitted to others from someone who is infected but not showing symptoms. This transmission includes people who:

  • have not yet developed symptoms (known as pre-symptomatic)
  • never develop symptoms (known as asymptomatic)

Table adapted from: Cold or flu: know the difference / Know the flu facts - Fact sheet, Government of Canada, 2019, and Coronavirus disease (COVID-19): Frequently asked questions (FAQ) , Government of Canada, 2020.

  • Fact sheet last revised: 2020-12-02

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Business Continuity Planning

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Organize a business continuity team and compile a  business continuity plan  to manage a business disruption. Learn more about how to put together and test a business continuity plan with the videos below.

Business Continuity Plan Supporting Resources

  • Business Continuity Plan Situation Manual
  • Business Continuity Plan Test Exercise Planner Instructions
  • Business Continuity Plan Test Facilitator and Evaluator Handbook

Business Continuity Training Videos

The Business Continuity Planning Suite is no longer supported or available for download.

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Business Continuity Training Introduction

An overview of the concepts detailed within this training. Also, included is a humorous, short video that introduces viewers to the concept of business continuity planning and highlights the benefits of having a plan. Two men in an elevator experience a spectrum of disasters from a loss of power, to rain, fire, and a human threat. One man is prepared for each disaster and the other is not.

View on YouTube

Business Continuity Training Part 1: What is Business Continuity Planning?

An explanation of what business continuity planning means and what it entails to create a business continuity plan. This segment also incorporates an interview with a company that has successfully implemented a business continuity plan and includes a discussion about what business continuity planning means to them.

Business Continuity Training Part 2: Why is Business Continuity Planning Important?

An examination of the value a business continuity plan can bring to an organization. This segment also incorporates an interview with a company that has successfully implemented a business continuity plan and includes a discussion about how business continuity planning has been valuable to them.

Business Continuity Training Part 3: What's the Business Continuity Planning Process?

An overview of the business continuity planning process. This segment also incorporates an interview with a company about its process of successfully implementing a business continuity plan.

Business Continuity Training Part 3: Planning Process Step 1

The first of six steps addressed in this Business Continuity Training, which detail the process of building a business continuity plan. This step addresses how organizations should “prepare” to create a business continuity plan.

Business Continuity Training Part 3: Planning Process Step 2

The second of six steps addressed in this Business Continuity Training, which detail the process of building a business continuity plan. This step addresses how organizations should “define” their business continuity plan objectives.

Business Continuity Training Part 3: Planning Process Step 3

The third of six steps addressed in this Business Continuity Training, which detail the process of building a business continuity plan. This step addresses how organizations should “identify” and prioritize potential risks and impacts.

Business Continuity Training Part 3: Planning Process Step 4

The fourth of six steps addressed in this Business Continuity Training, which detail the process of building a business continuity plan. This step addresses how organizations should “develop” business continuity strategies.

Business Continuity Training Part 3: Planning Process Step 5

The fifth of six steps addressed in this Business Continuity Training, which detail the process of building a business continuity plan. This step addresses how organizations should define their “teams” and tasks.

Business Continuity Training Part 3: Planning Process Step 6

The sixth of six steps addressed in this Business Continuity Training, which detail the process of building a business continuity plan. This step addresses how organizations should “test” their business continuity plans. View on YouTube

Last Updated: 12/21/2023

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  • Business Continuity Plan Basics
  • Understanding BCPs
  • Benefits of BCPs
  • How to Create a BCP
  • BCP & Impact Analysis
  • BCP vs. Disaster Recovery Plan

Frequently Asked Questions

  • Business Continuity Plan FAQs

The Bottom Line

What is a business continuity plan (bcp), and how does it work.

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Investopedia / Ryan Oakley

What Is a Business Continuity Plan (BCP)? 

A business continuity plan (BCP) is a system of prevention and recovery from potential threats to a company. The plan ensures that personnel and assets are protected and are able to function quickly in the event of a disaster.

Key Takeaways

  • Business continuity plans (BCPs) are prevention and recovery systems for potential threats, such as natural disasters or cyber-attacks.
  • BCP is designed to protect personnel and assets and make sure they can function quickly when disaster strikes.
  • BCPs should be tested to ensure there are no weaknesses, which can be identified and corrected.

Understanding Business Continuity Plans (BCPs)

BCP involves defining any and all risks that can affect the company's operations, making it an important part of the organization's risk management strategy. Risks may include natural disasters—fire, flood, or weather-related events—and cyber-attacks . Once the risks are identified, the plan should also include:

  • Determining how those risks will affect operations
  • Implementing safeguards and procedures to mitigate the risks
  • Testing procedures to ensure they work
  • Reviewing the process to make sure that it is up to date

BCPs are an important part of any business. Threats and disruptions mean a loss of revenue and higher costs, which leads to a drop in profitability. And businesses can't rely on insurance alone because it doesn't cover all the costs and the customers who move to the competition. It is generally conceived in advance and involves input from key stakeholders and personnel.

Business impact analysis, recovery, organization, and training are all steps corporations need to follow when creating a Business Continuity Plan.

Benefits of a Business Continuity Plan

Businesses are prone to a host of disasters that vary in degree from minor to catastrophic. Business continuity planning is typically meant to help a company continue operating in the event of major disasters such as fires. BCPs are different from a disaster recovery plan, which focuses on the recovery of a company's information technology system after a crisis.

Consider a finance company based in a major city. It may put a BCP in place by taking steps including backing up its computer and client files offsite. If something were to happen to the company's corporate office, its satellite offices would still have access to important information.

An important point to note is that BCP may not be as effective if a large portion of the population is affected, as in the case of a disease outbreak. Nonetheless, BCPs can improve risk management—preventing disruptions from spreading. They can also help mitigate downtime of networks or technology, saving the company money.

How To Create a Business Continuity Plan

There are several steps many companies must follow to develop a solid BCP. They include:

  • Business Impact Analysis : Here, the business will identify functions and related resources that are time-sensitive. (More on this below.)
  • Recovery : In this portion, the business must identify and implement steps to recover critical business functions.
  • Organization : A continuity team must be created. This team will devise a plan to manage the disruption.
  • Training : The continuity team must be trained and tested. Members of the team should also complete exercises that go over the plan and strategies.

Companies may also find it useful to come up with a checklist that includes key details such as emergency contact information, a list of resources the continuity team may need, where backup data and other required information are housed or stored, and other important personnel.

Along with testing the continuity team, the company should also test the BCP itself. It should be tested several times to ensure it can be applied to many different risk scenarios . This will help identify any weaknesses in the plan which can then be corrected.

In order for a business continuity plan to be successful, all employees—even those who aren't on the continuity team—must be aware of the plan.

Business Continuity Impact Analysis

An important part of developing a BCP is a business continuity impact analysis. It identifies the effects of disruption of business functions and processes. It also uses the information to make decisions about recovery priorities and strategies.

FEMA provides an operational and financial impact worksheet to help run a business continuity analysis. The worksheet should be completed by business function and process managers who are well acquainted with the business. These worksheets will summarize the following:

  • The impacts—both financial and operational—that stem from the loss of individual business functions and process
  • Identifying when the loss of a function or process would result in the identified business impacts

Completing the analysis can help companies identify and prioritize the processes that have the most impact on the business's financial and operational functions. The point at which they must be recovered is generally known as the “recovery time objective.”

Business Continuity Plan vs. Disaster Recovery Plan

BCPs and disaster recovery plans are similar in nature, the latter focuses on technology and information technology (IT) infrastructure. BCPs are more encompassing—focusing on the entire organization, such as customer service and supply chain. 

BCPs focus on reducing overall costs or losses, while disaster recovery plans look only at technology downtimes and related costs. Disaster recovery plans tend to involve only IT personnel—which create and manage the policy. However, BCPs tend to have more personnel trained on the potential processes. 

Why Is Business Continuity Plan (BCP) Important?

Businesses are prone to a host of disasters that vary in degree from minor to catastrophic and business continuity plans (BCPs) are an important part of any business. BCP is typically meant to help a company continue operating in the event of threats and disruptions. This could result in a loss of revenue and higher costs, which leads to a drop in profitability. And businesses can't rely on insurance alone because it doesn't cover all the costs and the customers who move to the competition.

What Should a Business Continuity Plan (BCP) Include?

Business continuity plans involve identifying any and all risks that can affect the company's operations. The plan should also determine how those risks will affect operations and implement safeguards and procedures to mitigate the risks. There should also be testing procedures to ensure these safeguards and procedures work. Finally, there should be a review process to make sure that the plan is up to date.

What Is Business Continuity Impact Analysis?

An important part of developing a BCP is a business continuity impact analysis which identifies the effects of disruption of business functions and processes. It also uses the information to make decisions about recovery priorities and strategies.

FEMA provides an operational and financial impact worksheet to help run a business continuity analysis.

These worksheets summarize the impacts—both financial and operational—that stem from the loss of individual business functions and processes. They also identify when the loss of a function or process would result in the identified business impacts.

Business continuity plans (BCPs) are created to help speed up the recovery of an organization filling a threat or disaster. The plan puts in place mechanisms and functions to allow personnel and assets to minimize company downtime. BCPs cover all organizational risks should a disaster happen, such as flood or fire.  

Federal Emergency Management Agency. " Business Process Analysis and Business Impact Analysis User Guide ." Pages 15 - 17.

Ready. “ IT Disaster Recovery Plan .”

Federal Emergency Management Agency. " Business Process Analysis and Business Impact Analysis User Guide ." Pages 15-17.

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