PV case processing activity is becoming one of the most outsourced activities in pharmacovigilance. Indeed, safety teams need a more efficient way of managing safety caseloads and effectively using the continuously increasing data to their advantage.
Outsourcing your PV case processing activity to our team guarantees high-quality PV data, effective medical case assessment, and rapid submission of cases to competent authorities and/or partners, which ensures regulatory compliance.
The activity can be chosen to be performed according to the client’s specific procedures or according to our internal procedures.
Case processing includes the following steps:
- Receipt of a Case Report
- Registration of a Case Report
- Validation of a Case Report
- Triage
- Duplicate Check
- Data Entry
- Quality Control of Data Entry
- Medical Assessment
- Transmission to Authorities or Partner
- Closure
- Archiving
Do you want to learn more about PV data processing activity? Check this article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5654220/
ML PV and Medical Writing Consulting 