A boat in the middle of a storm.

A life raft for clinical research: How sponsors, CROs, and vendors can buoy sites drowning in DCT technology

By Mary Costello and Brad Hightower, The Association of Clinical Research Professionals (ACRP)

Talk to nearly any clinical research site professional today and you’ll likely hear their mounting struggles adopting and managing new technology. Site staff are treading water as wave after wave of technology complexity crash over their heads. They need a life raft before they drown.

While many professionals working in drug development were fortunate to have the option of working remotely during the height of the pandemic, clinical site staff such as healthcare workers were on the front lines. They were the unsung heroes of COVID-19. The unprecedented speed with which COVID vaccines were developed was thanks to the incredible commitment of clinical site teams worldwide—that, and the sudden adoption of a modern clinical research model called decentralized clinical trials (DCTs).

Hybrid (onsite/offsite) and fully remote DCTs have proven to provide reliable options for trials during unprecedented events like a pandemic lockdown, as well as the potential to solve some of the industry’s most deep-seated problems. For instance, DCT-related technology can add flexibility, expand access, and even improve population representation. However, as with all major innovations, the industry now faces the challenges of implementation at scale—and clinical research sites are shouldering a disproportionate burden.

The most recent Society for Clinical Research Sites (SCRS) annual survey reveals that technology is adding an average of 17.5 hours in training per study per site per month among the nearly 500 respondents—one principal investigator (PI) reported having more than 300 unique passwords and logins.{1} Further, PIs aren’t the only ones facing tech-related overload—Hightower Clinical’s clinical research coordinators (CRCs), for example, often must use eight or more systems for each study assigned. Read more …