Author: Blake Adams, VP of Marketing for Florence Healthcare
“Within hours, our clinical operations had to be fully remote. Patients couldn’t come on-site. Our team couldn’t get into the clinic. But we had to keep our studies on track and needed to continue to monitor patient safety,” says Catherine Gregor, Director of Clinical Research Administration for Vanderbilt-Ingram Cancer Center.
While Catherine was referring to a winter storm that shut her state down, the same thing happened worldwide when the COVID-19 pandemic forcibly shut down clinical operations. “Thankfully, we had put technology in place to mitigate COVID, so we were able to wake up this morning and pivot to fully remote operations in an hour,” says Catherine.
This new reality can be heard daily in conversations among study sites, sponsors, and CROs working in the clinical trial research environment. COVID forced the adoption of new technology across industries, but in clinical research, where innovation is historically slow, COVID forced the jump ten years or more before expected.
The adoption of digital research and remote collaboration was imperative to stay on top of operations in an industry solving daunting challenges like cancer. Add to this the requirement for record-breaking delivery of a vaccine, and we suddenly had the perfect setting for rapid digital transformation. The immediate benefit of this pivot to remote connectivity and digital research is evident – mitigating disruptions to clinical operations – but the long-term impact of this shift is now on every clinical operations leader’s mind.
A Digital Shift
In a December 2019 survey to clinical operations leaders, 6% indicated remote site access and monitoring were a top priority. Only 18% said most or all their monitoring visits were remote. Fast forward one year to the December 2020 survey, and 76% of clinical operations leaders said their monitoring visits were mostly or entirely remote, with 83% saying all their monitoring would be done remotely by 2022.
The numbers paint a clear picture: the shift to remote connectivity and digital research during COVID is changing the way we do research. In addition to reducing the impact of disasters like pandemics, snowstorms, and hurricanes, digital research transformation offers enormous advantages across compliance, efficiency, and safety.
“One of the clear early benefits of forcing everyone to a digital environment was the speed of signatures,” said Casey Braddy, Assistant Director of Research Operations at Vanderbilt-Ingram Cancer Center. “We went from weeks to four days or less for an average signature turnaround. What used to take an hour or more per day of a coordinator’s time to track down a PI [Principal Investigator] on our spread-out medical campus now requires three seconds of a mouse click.”
In addition to internal operations changes for sites, the remote connectivity, site access, startup, and monitoring functions for sponsors deliver real impact on study speed and safety. A fully integrated eISF and remote site access platform can help research organizations respond to the changing environment due to COVID-19 and further progress COVID research with the capability to perform remote monitoring where approved by regulatory authorities and ethics committees.
Digital Research Ready: The New Requirement
What does this mean for the industry? The expectation of digital research and remote connectivity will shape how sponsors develop their protocols, what capabilities they require of their CRO partners, and what technology they expect at study sites.
Suji Shetty, Vice President of Maxis Medical, said in a recent podcast, “We are now at a stage where CROs [Contract Research Organizations] will not win sponsor bids without robust digital research and remote site access technology. Sponsors must demand their CROs be able to continue operations when future pandemics and natural disasters strike, and that they take advantage of the clear efficiencies of the technology.”
In today’s landscape, this shift is seen quite clearly. Sponsors and CROs now more commonly seek out digital research-ready study sites before launching new studies. They want to know that sites have a technology infrastructure in place to handle remote startup, monitoring, and source data verification, or they want to know the site is willing to take on new technology.
Though we would have preferred not to experience the COVID pandemic, there are lessons we can glean as an industry to move forward. There is now an expectation among the research sector and the broader population that research should produce breakthrough results in record time. We can only accomplish this through the collaboration of people, processes, and technology.
About the Author
Blake Adams is the VP of Marketing for Florence Healthcare. He joined Florence in 2017 to help research teams advance cures by introducing them to innovative software solutions. He is a passionate storyteller and growth leader who also loves to travel – he’s been to over 30 countries!