Post-Marketing Pharmacovigilance

Including MedWatch Reporting

 

Clinquest provides the services to comply with FDA, EMA and ICH regulations for drug safety and pharmacovigilance, including assessing reportability based on the seriousness and expectedness of adverse events.

  • Comprehensive Case Management 
    • Data entry, narrative generation, and quality-control
    • MedDRA Coding of adverse events (including regular upversioning)
    • Follow-up information inquiries
    • MedWatch/CIOMS report generation
    • Medical Review, including MedDRA coding review and trend analyses, by Pharmacovigilance trained physicians
    • Expedited reporting in the US and EU
    • Follow-up case processing
    • Case closure
    • Periodic Safety Reports
    • Reconciliation of Adverse Events with business partners and Quality Assurance group
    • Review of Global Safety Agreements
    • Literature review
    • Risk Management

Specialized Pharmacovigilance Services

  • Periodic Safety Reports
  • Special Issue work-up
  • Integrated Safety Summaries
  • Company Core Data Sheet generation and maintenance
  • Develop and Implement Safety and Surveillance Programs for investigational and marketed products
  • Risk Mitigation and Management Plans
  • Risk Evaluation and Mitigation Programs (REMS)
  • Quality Control Systems for Off-Shored Pharmacovigilance Services
  • Mock Safety Audits
  • Audit Periodic Safety Reports to the FDA to assess accuracy, completeness and confirmation of adherence to regulations
  • Audit Preparation
  • Conduct data review, coding and narrative review, and source document verification on a set percentage of Adverse Event case reports.
  • Placement of trained Pharmacovigilance Specialists at client companies

Clinquest’s trained Pharmacovigilance professionals specialize in the management of Post-Marketing Adverse Events & Adverse Device Events (AEs/ADEs) and Serious Adverse Events & Serious Adverse Device Events (SAEs/SADEs). We can customize processes to meet individual client needs, and provide Medical Oversight Services (Chief Medical Officer) for clients that do not have internal medical expertise or available medical resources.