Independent Consultant
C. C. Westfall, Inc., Pa
Wilmington, North Carolina, United States
- Pre-Contractual, Routine (In-process), Post-Study, and “For Cause” GCP auditing (onsite and remote) of domestic and international Phase I-IV investigative sites, sponsors and third-party vendors including bioavailability (BA) and bioequivalence (BE) facilities, CROs, clinical laboratories (commercial/academic), bioanalytical laboratories, pharmacogenetics laboratories, computer system validation (21Part11), data management groups (paper/electronic), electronic patient reported outcomes (ePRO) providers, Interactive Response System (IRT) providers, centralized diagnostic services (Angiography, CIMT, Echocardiograms, Electron Beam Tomography, ELISA, FISH, IHC, SPECT, X-Ray), Institutional Review Boards (IRBs), case report form printing facilities, bio-repositories, drug depots, pharmacovigilance (PVG) providers, investigator-initiated sponsored research (IISR), pharmacometrics (modeling & simulation services), independent data monitoring boards (IDMB), medical information call centers, duplicate subject identification services, medical device manufacturers, and blood source establishments- Mock regulatory inspections (e.g., FDA NDA, PMA, BLA, REMS)- Systems process analysis and SOP gap analysis- Database comparison auditing of electronic databases to case report forms and/or clinical study report.
