Prepare for Tomorrow’s Unexpected Challenges Today to Bolster Clinical Trial Operations

Krissa Packard

Krissa Packard, MS, CRA, ACRP-CP, Research Program Director, Medical College of Wisconsin

While it may sound like a contradiction, there are in fact ways to prepare for the unexpected by drawing on lessons learned under fire in the past. Just ask Krissa Packard, MS, CRA, ACRP-CP, research program director, and Amber Brandolino, MS, CCRC, a clinical research coordinator, both at the Medical College of Wisconsin.

Leveraging tools, templates, and a bit of tenacity, they were able to maintain some clinical trial studies throughout the entire COVID-19 pandemic. “We had some hiccups, but we never came to a complete stop,” Brandolino says.

Packard and Brandolino have developed programs designed to make the next challenge—be it a natural disaster or other unforeseen disruption—more manageable and less scary. It begins with focusing on the work and your team, they say.

“We’re optimistic that with the proper planning you can sustain clinical operations” during even the most trying of times, Packard says. “We’ve learned to leverage technology and be nimbler with hybrid approaches for doing some work remotely when possible,” she adds.

The nature of the unexpected makes it difficult to plan for, they allow, but both agree there are “common denominators” to mitigating future problems when disaster strikes. For example, building in a clear line of communication with your team in advance is critical, Brandolino says. “We’ve just been through a time of forced creativity,” she notes, learning how to operate remotely and how to “conduct clinical research in a different way.”

“Obviously, we wish the pandemic never happened,” Brandolino adds. However, it has left industry in a better position to handle future challenges, she believes. “It’s time to reflect on lessons learned to help us avoid a scramble” next time, she says.

“We are prepared for emergencies in life,” Packard says. “But we aren’t always prepared for them as contract research organizations. We can prepare now for the next unexpected event.”

“We can build a better foundation today to deal with the challenge of tomorrow,” Brandolino says.

Author: Michael Causey