Technology Takes the Spotlight in Clinical Trial Operations

“Everyone recognizes the need for change,” says Jim Reilly, vice president for research and development strategy at Veeva Systems. “It’s time to automate, simplify, and digitize information sharing between sites and sponsors.” Today’s methods are still incredibly outmoded, with 40% of sites and sponsors still using paper to share information, he adds.

Based on a recent Veeva survey of more than 500 clinical trial professionals both domestic and international, Reilly is in the decided majority when it comes to expressing a desire for change. The respondents say they need to improve information sharing between study partners to reduce manual processes (75%), improve visibility and oversight (58%), and speed trials (58%).Consistent with the aim to streamline information sharing and speed trials, more than one-third say easier collaboration (44%) and faster collection of site essential documents (42%) are critical to improving study start-up.

The study was conducted in March and April, still relatively early days in terms of COVID-19’s impact on clinical trials, but Reilly joins others in saying the pandemic has been a catalyst that will speed the pace of technology adoption. “Anecdotally, we’ve seen it accelerating since we completed the survey,” he says. “I think we’ve reached a tipping point” where there’s no going back to the way trials were conducted pre-pandemic, he adds.

“Innovation often takes a sea change event, which is usually something more positive like a new invention” to spur new ways of doing things, Reilly says.

Virtually all the respondents to Veeva’s most recent annual survey (98%) report the need to unify clinical applications, and 83% say their organizations have, or plan to have, an initiative in place to do so.

According to the Veeva study, standalone, eClinical applications, including electronic data capture (91%), electronic trial master files (eTMF) (78%), and clinical trial management systems (CTMS) (64%), are now utilized by most sponsors and contract research organizations (CROs) as they steadily adopt function-specific technologies to better automate clinical trials.

Sponsors and CROs have made significant progress modernizing major clinical areas such as eTMF to increase visibility into TMF status (62%), improve governance and oversight (52%), and ensure a constant state of inspection readiness (52%). Organizations that use purpose-built CTMS applications report better compliance with standards (58%), greater visibility (52%), and improved governance and oversight (48%) compared to those using other methods to manage study execution.

Author: Michael Causey