Sites are overwhelmed by the increasing number and complexity of technology solutions required to execute clinical trials. This is exacerbated by the increasing number of solution providers selected. Currently, research sites are typically required to use sponsor-provided technology systems. The Decentralized Trials and Research Alliance's (DTRA's) "Bring Your Own Technology" initiative aims to enable clinical research sites to use their own validated technology systems in industry-sponsored clinical trials while maintaining regulatory compliance and sponsor oversight. The objective is to reduce operational inefficiencies, improve data quality, and enhance site and patient experiences. This session will share the work done by DTRA to date to define a process to enable adoption of site-preferred technology in registrational trials. Using eConsent as a model, key considerations and impact assessments conducted to identify opportunities and challenges from a multi-stakeholder perspective will be shared. The work continues in 2025-26, focusing on site-preferred eSource adoption by sponsors.

CEU: 1.00 ACRP

Speakers:

• Joe Dustin, Founder and Principal, Dauntless eClinical Strategies

• Rick Greenfield, BBA-IS, Founder & Chief Strategy Officer, RealTime eClinical Solutions

• Brandon Maggio, Global Head of Digital Operations & Process Optimization, Glaxo Smith Kline

• Jane Myles, Program Director, Decentralized Trials and Research Alliance