2025 SCRS Global Site Solutions Summit: How Standardized CDAs Can Accelerate Site Activation

In a video interview on-site with Applied Clinical Trials at the 2025 SCRS Global Site Solutions Summit, Christine Senn, PhD, SVP, site-sponsor innovation, Advarra, discussed the inefficiencies in training within the clinical research industry, highlighting the redundancy and lack of transferability of training across therapeutic areas. She advocated for a more effective use of adult learning principles in site investigator visits (SIVs), suggesting that extensive training on patient enrollment and randomization is crucial, as these initial steps set the foundation for the entire study. Senn also discussed Advarra’s latest initiative, which aims to streamline the process of creating confidential disclosure agreement (CDAs) by addressing inconsistencies within subgroups.

ACT: What changes in workflows would make the biggest difference in accelerating site activation and improving transparency with sites?

Senn: One of the things that I would love to see is a personal project of mine, so Advarra has a site-sponsor consortium that we have 20 members from sites, CROs, and sponsors, and our very first project was just launched, was the CDA project. What we did was we had everyone look at their processes from their own subgroup, and how could we make that process the most streamlined possible for that subgroup? That is part of it, and it doesn't seem like a big thing, but there is a lot of inconsistency of how CDAs are done that can add time, just like my own part as a site, my own part is a sponsor, but we took it a step further and decided that we would write a CDA template and offer it to everyone, so it's completely downloadable. I just told someone who wasn't involved in the project today, and she wanted to know about it immediately, because she's in site selection and said the CDA process can take so long, and it really shouldn't be that complicated. The CDA template is available to anybody, downloadable Word version, and it's bilateral, meaning that both the site and the sponsor, or CRO, whoever they're with, is being protected, which has been a big thing, especially for site networks lately, and especially for health care systems. So why bother negotiating it? Let's just have that. We also did some interesting things around governance and jurisdiction, legally, that I think people could have feelings about, but I think it could actually be really amazing if we can work with your legal teams. That's one of them, for sure.