I was delighted to join several of my Koneksa colleagues in person at the recent 13th Summit for Clinical Ops Executives (SCOPE) conference in Orlando, Florida.
The focus SCOPE has on clinical operations is incredibly valuable, as it creates a forum for discussing complex implementation considerations that aren’t typically covered in depth at either scientific congresses or trade shows. I found this year’s meeting to be a great barometer for the extent to which digital technologies are being adopted—and an encouraging showcase of some of the next steps our industry is taking to start scaling digital medicine in practice. We saw several biopharma organizations present their recent work in this space, including Pfizer, Biogen, Regeneron, and Roche.
I also noticed that sponsors are increasingly paying attention to the 2021 FDA Draft Digital Health Technology guidance. This new FDA guidance is an important document that builds on the agency’s 2009 PRO Guidance in a way that signals its active interest in the development and qualification of new validated digital health technologies. The draft guidance is also representative of a larger, more significant shift, which is that regulators are increasingly engaging with sponsors—even proactively—for conversations about the use of digital biomarkers.
The healthcare industry is seeing increased enthusiasm and momentum from all players for digital clinical trial solutions and the technology and science that make them possible.
SCOPE was filled with fascinating discussions about the future of clinical trials, and Koneksa was able to connect with more teams interested in deploying patient-centric digital biomarker solutions for those trials. If you’re another interested party, contact Koneksa to learn more about our capabilities and how our team can support both clinical research and patient care.