Clinical Development Vendor Qualification: “Check-The-Box” Exercise?

Are your company’s clinical development vendor qualification (VQ) activities a “Check-The-Box” exercise because someone said that regulators expect it? Or are your VQ activities a comprehensive first step in managing the risk of doing business with a new vendor?

Today, almost all clinical trials are implemented utilizing multiple clinical vendors that provide key services that enable the clinical development process. Across the pharmaceutical industry, there are many differences in how companies approach this activity. In fact, the scope and approach of VQ activities vary significantly from company to company across the industry. The reality is that regulators—as outlined in ICH E6 R2 & ICH Q10—expect pharmaceutical companies to verify contracted vendors have adequate qualifications to complete the work they’re contracted to deliver. These VQ regulatory requirements impact both Sponsors and Vendors, with Vendors managing both evaluation by Sponsors for their qualifications and evaluation of their own sub-contractors that support clinical development efforts. Incrementally, revisions found in ICH E6 R2 also set expectations