It is a critical requirement for all external parties (i.e. vendors, partners, suppliers) contributing to the conduct of a clinical trial to be capable, committed, and resourced to meet their contractual responsibilities.  The question is how do you make certain that what has been presented in bid defenses, sales materials, and even previous experience with a vendor will continue to fulfill your organization’s current quality expectations for this clinical program?

With the proliferation of outsourced approaches for all aspects of clinical trials, those that are responsible for vendor qualification, selection, contracting, and ongoing oversight must be ready to meet the daunting challenge of addressing risk mitigation and management across a wide variety of vendors.  A robust qualification and oversight procedural approach is crucial to ensure that patient safety and data integrity remains the highest priority.  If that is not difficult enough, clinical staff must continue to actively mitigate the ancillary budget eating risks including the rising time and cost of amendments, associated change orders, as well as delays due to under-performing sites.

Introducing a risk-based approach to selecting, contracting, and overseeing vendors, any size organization can clearly demonstrate oversight compliance.  Deploying a consistent process for all contracted services, that is utilized throughout the entire contract of a vendor will allow an organization to clearly reap the benefits of quality driven vendors and demonstrate a robust oversight program.

Stay tuned for next month’s blog!