Pharmacovigilance/Drug Safety

Timely reporting and management of serious adverse events (SAEs) in clinical trials is vital to patient safety and compliance to regulatory requirements.

Everest provides clinical trial pharmacovigilance services for drug safety monitoring and management of SAEs, Adverse Drug Reactions (ADRs), pregnancies, and other patient safety events as per clinical trial protocols. Our Clinical Trial Safety Associates work closely with our Clinical Data Managers to ensure timely processing and reporting of such events reported by clinical trial personnel, to follow up for resolution of data discrepancies, and to achieve timely and quality final reports of the event information.

Everest Clinical Trial Pharmacovigilance/Drug Safety Surveillance services include the following:

  • Project management of drug safety services, including authoring of pharmacovigilance procedural documents and documentation of drug safety surveillance activities

  • Setup and maintenance of safety database in Oracle Argus

  • Study-specific SAE report form and completion instructions for investigators

  • Case intake and triage

  • Data entry into safety databases

  • Case processing (review and query/follow-up with study sites)

  • Safety narrative writing (manual writing and SAS automation in writing large number of narratives)

  • Medical review of cases for accuracy

  • Medical coding using MedDRA

  • Assessment for relatedness and expectedness

  • SAE reconciliation between safety and clinical databases

  • Unblinding of SUSARs

  • Safety report generation (CIOMS/MedWatch)

  • Reports to investigator for SUSARs

Have questions?
Email Us
Subscribe now to receive updates
Subscribe To ECRS Corp