Clinical Pharmacovigilance Services

Serious Adverse Event Reporting

 

Clinical trials for investigational products have different safety reporting requirements from marketed products. Clinquest’s trained pharmacovigilance staff specializes in the management of safety events from clinical trials.

Core Activities for Clinical Pharmacovigilance :

  • Development and management of pre-clinical pharmacology and toxicology/safety studies 
  • Development of clinical protocol safety section, reporting forms, and other tools 
  • Development of Investigator’s Brochure 
  • Adverse event case processing including serious adverse event management, Suspected Unexpected Serious Adverse Reaction reports (SUSARS), and required expedited reporting in the US and EU 
    • Initial event receipt and triage 
    • Case processing, including data entry, narrative generation, and quality- control 
    • MedDRA Coding (including regular upversioning) 
    • Querying for additional information 
    • MedWatch/CIOMS report generation 
    • Medical review 
      • MedDRA coding review 
      • Trend analyses 
      • Risk management 
    • Follow-up case processing 
    • Case closure 
  • Clinical/Safety data reconciliation of AE/ADE and SAE/SADE on an ongoing basis or at study completion
  • Clinical Study Reports and Annual Reports 
  • Integrated Safety Summaries

These core activities can be stand-alone or combined with any clinical program. Clinquest’s trained Pharmacovigilance professionals can be located in-house or on-site at the client location. We can customize processes to meet individual client needs, and provide Medical Oversight services for clients without internal medical expertise or available medical resources.
Clinquest can also provide clinical trial medical monitoring (including protocol deviation follow-up and review, clinical laboratory review, SAE/SADE case review, and medical coding oversight), 1571 responsibility, safety review and sign-off on final study reports, and participation in or management of Data Safety Monitoring Boards (DSMB).