How partnership ensured a successful first digital trial | Read now

Medable delivers eConsent and a two-week study startup for a client’s first-ever digital trials.

For the last twenty years, clinical trials have been steadily digitizing. 

As the EDC and eTMF systems of the early 2000s gave way to the eCOA and eConsent tools of the 2010s, site, and participant experiences throughout clinical research were improved. 

Since our inception in 2015, Medable has conducted over 300+ digital and decentralized trials using eCOA, eConsent, telehealth, and more. However, just as a bell curve shows, adoption rates for new technologies can wildly vary across our industry. While some organizations quickly implement new technologies, others take a more cautious approach. 

Recently, our team had the opportunity to partner with an academic research organization in this situation. 

U.S. Renal Care was running a kidney cancer study in the United States and wanted to use Medable’s electronic informed consent (eConsent), Total Consent, to facilitate the informed consent process. However, this was the first time they’d ever used any technology, and the trial's patient population skewed older, around 65 years of age on average, meaning they may be potentially less comfortable with newer technologies.

To ensure success, Medable employed a partnership approach early, that began by understanding what made USRC unique.  “We clearly understood the client's scope and needs,” stated Nick Fuentes, team leader and Senior Solutions Manager. “With that knowledge, Medable provided tailored recommendations according to their needs.

Together, this team, which included Mihai Viisan, a Solution Design SME, Luka Ajduk, a Product Implementation Lead, and Ted Meyer, the Supply Chain Coordinator, built a trusting working relationship in which Medable led study implementation.

This approach paid off, with Medable completing the full study build, Quality Assurance (QA), and User Acceptance Testing (UAT) processes in just two weeks - an extremely rapid timeline that required the collaboration of sites, sponsors, and study teams.

One key aspect was creating virtual ‘office hours’ to walk the site teams through using Total Consent with patients step-by-step. While Medable provides eLearning training courseware, recognizing this demographic might need hands-on support. The open office hours allowed sites to practice new workflows within the system using mock data to practice real-life scenarios they’d face every day.

Geoffrey A. Block, MD,  Associate Chief Medical Officer & SVP of Clinical Research and Medical Affairs at U.S. Renal Care noted their success stating, “Medable and their eConsent platform allowed us to rapidly launch and successfully execute recruitment for a large, multi-facility clinical trial. Use of the platform was straightforward and their training demo modules made it easy for our organization to implement.” 

The right partner provides the right path

For organizations still tentative about new technologies like Medable’s Total Consent and decentralized trials, this story demonstrates the value of an experienced implementation partner. 

It’s helpful for organizations to understand their makeup, goals, strengths, and weaknesses when searching for a technology partner. As always, bridging the digital divide requires more than great technology. It takes a guide deeply versed in the processes and nuances involved in these transformational shifts. 

The right partner can clear the path for clinical innovation.