Article | September 27, 2018

Maximizing Efficiencies In Site Enrollment II - Confidentiality Disclosure Agreements

Source: TransPerfect

By Anuj Thapar, Trial Interactive, TI E-Feasibility Product Manager

Meeting

Time for more site feasibility talk!

Last time, we talked about how pharma companies and CROs are recognizing the need for focused electronic feasibility (e-feasibility) solutions to address inefficiencies in the site selection process. Specifically, we discussed the opportunities to automate site questionnaires and the associated response tracking. While these are the obvious gains of e-feasibility, there are many other, more nuanced advantages. One such advantage being simplifying the execution of confidentiality disclosure agreements.

As the product manager for TI E-Feasibility, I have had the opportunity to collaborate with clinical teams and discuss the challenges of site identification through site selection. One of the most commonly referenced topics is confidentiality disclosure agreements (CDA). CDAs bind a site to privacy practices and safeguard billions of dollars spent by a sponsor in discovering a new drug (Mullin, 2014) Which is why CDAs must be fully executed and collected by sponsors/CROs for all sites before any critical and confidential information can be shared. This process may take anywhere between a few weeks to a few months, depending upon the tools and methods deployed by the CRO/ sponsor in this process.

Why is this simple sounding agreement so challenging for clinical teams? Let’s explore through five common CDA pain points: