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:

  • Development and maintenance of a study-specific Safety Management Plan.
  • Building sponsor specific, compound, and study level safety database within Oracle Argus.
  • SAE notification via system alert emails and documentation.
  • Seamless dataflow between the clinical database and safety database via programmatic E2B mapping and data import.
  • Case assessment, processing, and management.
  • Electronic generation of regulatory reports (e.g., MedWatch/CIOMS forms, E2B files).
  • Electronic generation of patient narratives.
  • Expedited reporting to regulatory agencies and investigators (for reporting to IRB/IEC).
  • Simple and streamlined annual safety updates for compounds/programs and individual studies.
  • Performing integrated data analyses and generation of Integrated Summary of Safety (ISS) reports.
  • Performing analysis of safety database, trending, and signal detection for ongoing clinical trials and for post-marketing drug safety surveillance activities.

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