Clinical Development Safety and Pharmacovigilance

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  • 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.