Clinical Pharmacovigilance Service
Clinquest’s trained pharmacovigilance staff specializes in the management of clinical trial AEs and SAEs, including initial AE/SAE receipt, case processing and follow-up, medical review, and case closure. We process cases in our proprietary database and code in MedDRA. Data are output to MedWatch or CIOMS. We can conduct AE and SAE reconciliation with the clinical database on an ongoing basis or at the end of the study at the option of the client. Clinquest maintains all hard copy documents under strict security.
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 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).
Pre-Marketing Pharmacovigilance Core Services include:
- Development of clinical protocol safety section, reporting forms, and other tools
- Database entry, narrative writing, and maintenance of adverse event cases
- MedDRA coding of adverse events, including regular upversioning to current MedDRA version
- Adverse event case processing including serious adverse event management and expedited reporting in the US and EU
- Medical review and oversight, including coding review, trend analyses, and risk management
- Placement of trained Pharmacovigilance professionals into local client companies
- Responsible Person for EudraVigilance
- Legal Representative of a sponsor not established in an EU member state