Adverse Event Reporting

Adverse Events are collected and triaged for classification, reportability, and safety signals. Each event is entered into the safety database and an Individual Case Safety Report of the patient’s event(s) is composed and submitted to regulatory agencies. The individual Adverse Events are further analyzed on a regular basis to assess for changes in the benefit-risk profile of the medicinal product.

Core Activities for Adverse Event Reporting and Management:

  • Collection of Adverse Events and triage by trained specialists
  • Thorough and accurate documentation of Adverse Event case data for
    • Clinical Studies
    • Drugs
    • Biologics
    • Medical Devices
    • Dietary Supplements
  • Case processing, including data entry, narrative generation, and quality-control
  • MedDRA Coding (including regular upversioning)
  • Follow-up information inquiries
  • MedWatch 3500A/CIOMS report generation
  • Medical Review, including MedDRA coding review and trend analyses
  • Follow-up case processing
  • Case closure
  • Ad hoc aggregate safety data reports and analysis
  • Periodic Safety Reports


 

Why Choose Clinquest to do your Adverse Event Management?

  • Clinquest’s Pharmacovigilance and Medical Information Associates undergo a 3-week proprietary Pharmacovigilance training course with hands-on mentoring by experienced professionals
  • Our narratives are logical, comprehensive, and concise
  • Our case reports are quality-control checked and medically reviewed by a physician before finalization
  • Our proprietary safety database produces MedWatch and CIOMS I report forms, CIOMS II and PSR/PSUR line listings, and summary reports; it can be customized to produce additional reports as requested
  • We can optimize communication by working directly with our clients’ business partners
  • We send clear requests for additional information/clarification and process data received
  • We have flexible pricing options with granular contracts and no hidden costs

Communication and Adverse Event Report Quality

  • Clinquest’s responsibility is to get accurate and comprehensive data
  • Our thorough questioning of the reporter allows us to capture the relevant information correctly, concisely, and comprehensively
  • Our knowledgeable Pharmacovigilance specialists have the experience to work with reporters to interpret unclear event definitions and produce clear data for processing
  • We have the ability to construct clear event narratives from all methods of reporting, such as one to one conversations, telephone communication reports, emails, faxes, literature articles, and case report forms
  • We focus on the chronology of the patient’s clinical course so the timeline of event-suspect product association is accurate
  • Our follow-up and documentation are consistent
  • We use a knowledge-based preparation approach
    • We obtain product labels and information on capabilities, specifications, restrictions,
      uses, compatibilities, contra-indications, and expected adverse events
    • We can access existing records and create new records in real-time
    • We prepare guidance documentation to ensure consistent and clean data entry
  • We have a streamlined system to process, access, and send out information
  • We utilize SOPs, work instructions, and procedures in the performance of our data entry and documentation activities
  • We focus on maintaining clear, professional, and documented communication with Clients, Reporters, and Business Partners