When GCP & GMP Meet

Developing safe and effective drugs requires a coordinated effort across a diverse set of disciplines. This is easier to observe at some points in the process than at others. Once a product is well into human trials, it can be easy to forget that developments on the manufacturing side of the house can affect the clinicians who are conducting the studies.

Site Selection: Don't Forget About the Study Drug

As a sponsor or CRO, you understand the importance of a thorough site selection process. A site needs to be able to meet enrollment targets and time frames, protect the rights and safety of study participants, execute the protocol, deliver quality data, and maintain GCP compliance. That’s what your site feasibility surveys and pre-study visits are designed to evaluate. And as you’re assessing a site’s abilities, the site is conducting its own feasibility process. They’re mining their patient database and assessing inclusion/exclusion criteria. They’re reviewing staff credentials and ensuring they have adequate resources to manage the number of subject visits and collect the data the protocol requires.

But when we conduct GCP audits, we find there’s one perspective that is sometimes overlooked by both sides: the needs of the study drug itself.