Clinical Development Safety and Pharmacovigilance
Vendor selection, management, and oversight.
GCP qualification, routine, and for-cause audits of contract research organizations (CROs), site management organizations (SMOs), phase 1 units, investigator sites, ancillary vendors, specialty and bioanalytical laboratories, and clinical databases.
Authoring, preparation, review and approval of ancillary clinical documents, such as IBs, pharmacy manual, monitoring plans, etc.
Review and approval of all trial documentation as per ICH E6 and FDA requirements.
GCP Training of internal and external personnel.
Trial Master File oversight and consulting.
Assist in the processing of SAEs, including review, authoring, evaluating SAE narratives; development of queries for sites, and case management.
Perform periodic safety reviews for trends and signal detection.
Expert clinical data review of clinical parameters (e.g. efficacy data, AEs, SAEs, laboratory parameters, and protocol deviations).
Consult on clinical supply chain and drug shipment issues.