Post-Marketing Pharmacovigilance

Clinquest’s pharmacovigilance professionals specialize in the management of post-marketing AEs and SAEs, including initial AE and 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. 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.

Post-Marketing Pharmacovigilance Core Services include:

• 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
• Reconciliation of adverse events exchanged as part of global safety agreements
• Periodic Safety Report generation
• Literature review performed monthly based upon sponsor parameters
• Placement of trained Pharmacovigilance professionals into client companies
• Responsible Person for EudraVigilance