Pharmacovigilance – also known as drug safety – describes the collection, analysis, monitoring and prevention of adverse effects in drugs and therapies, and is an essential function within a life science company.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has significant guidelines for companies conducting clinical trials. Organizations are obligated to set up the right systems and processes to identify, record, report and analyze safety signals that could arise during a trial.
Bioforum provides all the pharmacovigilance services required for your clinical trial.
- Setup Activities
- EudraVigilance Registration and Responsible Person (in case there are sites in the EU)
- Test & submit electronic SUSAR to EMA (in case there are sites in the EU)
- Safety Management Plan
- Database setup
- Legacy case entry
- Adverse Drug Reaction Case Activities
- Case entry and QC
- Case assessment, narrative writing, and causality/expectedness assessment
- Generate CIOMS/MedWatch
- MedDRA Coding
- Prepare electronic SUSAR
- Distribute paper SUSAR to sites (in case customer wishes to)
- Line listings
- Authoring of the DSUR (Development Safety Update Report)
- Strategic pharmacovigilance regulatory consultation