Regulatory inspection at site

Case Study 4


CHALLENGE/S

Preparing for USFDA inspection with only <48 hours’ of prior notice at one of the network sites for the Liposomal Doxorubicin study which was conducted for a US-based innovator pharmaceutical company.

OUR STRATEGY

• CBCC’s strategy involves keeping the sites ready for “ANYTIME INSPECTION READINESS” once the site closeout is complete.

• We contacted the site team and the sponsor immediately upon receiving notice regarding inspection.

• We sent our experienced and trained team at the site to assist them during the inspection.

• Provided orientation to the site team on how to handle the regulatory inspections.

• We represented our sponsor and during this inspection, provided all required documents/information to the FDA inspector maintaining close coordination with the sponsor throughout.

VALUE

Despite short notice, with our “ANYTIME INSPECTION READINESS” strategy, CBCC and its study site could successfully handle the USFDA inspection with no major findings. USFDA Inspector and the concerned site team appreciated CBCC for its unstinted support.

copyrights © 2020. All rights Reserved.