Service Description

We outsourced a panel of GLP testing of our product stability program. Testing include vial integrity, appearance, pH, sterility, & potency.

What Went Well

CRL, both their PA and MA facilities, have responded rapidly to our needs with well written protocols, reasonable budgets,and timely reports. Solo project managers make coordinating programs efficient. Cross-functional groups communication is good too.

What Could Be Improved

Staff turnover has resulted in poor transfer of project related specific details, that have resulted in timely and costly repeat testing. A testing issue developed because a minor mixing/timing step was overlooked by one of the technicians. Although the problem was detected by us and resolved by them, it created a question in protocol training and cross-training ...

Lessons Learned from the Experience

we learned that: we do not control the CRO's team or staff, and that no matter how many years of working with a CRO, their internal politics/staffing/organization can (and will most-likely) change. Therefore, frequent onsite monitoring by our staff is essential to the successful outcome out this CRO-partnership. We have to keep them focused on OUR project, not as a client, but as a partner...