Expert Insights

Expert Insights

Business Continuity for Drug Developers

Business Continuity for Drug Developers
09 July 2020

From patient participation alternatives and accelerated vaccine research to operational and data management challenges, COVID-19 is proving to be a disruptive force in the clinical research space, forcing the industry to scramble to keep up — and to stay ahead.

There are never guarantees about the future but there are ways to prepare to keep trials on track and make them flexible enough to weather outside influences that may come along in the future. Thinking ahead for business continuity sets you up for lasting success with long-term thinking and proactive planning.

Our Mary Mattes, Senior Vice President of global operations, recently led a webinar on Business Continuity for Drug Developers During the COVID-19 Pandemic. She discussed:

  • How to maintain communication pathways in a fast-changing environment
  • Customizing remote monitoring plans to stay nimble
  • Adapting to the evolution of data collection with technology such as eSource and eConsent
  • What to anticipate for the future when COVID-19’s impact recedes

In the webinar, Mattes explored some of the guiding principles that factor into a solid business continuity plan. Protecting patient safety, for example, is always top priority at any time, but deserves specific care and focus during unforeseen events. Trial integrity, regulatory guidance compliance, and flexibility to achieve sponsor milestones also need to be given careful consideration.

But planning a continuity strategy doesn’t need to be an all-at-once proposition; rather, identifying “waves” of responses and rolling out actions in a logical, measured pace will be the difference between floundering and solid business continuity. From the first wave — initiating discussions with sponsors and anticipating disruption of on-site monitoring, to the fifth wave, collecting COVID-19-related information in trials for future reporting and updating study databases to capture affected data — having a segmented plan can reduce risk and help ensure long-term success.

Another critical step is anticipating future waves beyond the last one. Thinking through your reopening strategy, including office locations and traveling monitors, can’t be overlooked. Technologies that the industry has been pushed to adopt during the pandemic, such as eSource and decentralized trials, will play vital roles in the clinical research industry’s continued move forward. The old logic holding many back — such as unclear regulatory support, site skepticism, and budget and time constraints — are no longer acceptable reasons to stay stuck in old ways. When the world reopens, clinical research will be moving forward; those who haven’t established a business continuity plan will undoubtedly be left behind.

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