Our Services
Some of what PrimeVigilance offers
(click on each triangle for further details):
- Infrastructure and Database
- Individual Case Safety Report (ICSR) processing
- Expedited reporting, including Eudravigilance
- Clinical trial SAE / SUSAR management
- Periodic reporting, including ASRs and PSURs
- Literature screening and review
- EU Qualified Person for Pharmacovigilance (QPPV)
- Detailed Descriptions of PV Systems (DDPS)
- Risk Management Plans (RMP)
- Training
- Audits
- Safety Data Exchange Agreements
- Signal Detection and evaluation; advice on safety issues
- Responding to enquiries from Authorities
- Identifying and communicating changes to Risk / Benefit
For more information contact PrimeVigilance today
PrimeVigilance
in conjunction with Elliot Brown Consulting and Ergomed