Our main focus is providing pharmacovigilance consulting services, including PV audits, gap analysis and closure for the client's PV system on a global level, as well as PV trainings. As a full-service pharmacovigilance CRO, our services include but are not limited to:
- Case processing including data entry, medical review, QC, submissions globally
- Aggregate report preparation (DSURs, PSURs, PBRERs, ASRs, PADERs)
- Literature screening for both ICSRs and aggregate reports
- EU and global Qualified Person for Pharmacovigilance (QPPV) services
- Review, update and preparation of PV SOPs
- PV QMS audits and gap analysis and closure, CAPA resolution
- PV Trainings, both in general and client-tailored
- Global risk management activities (RMP/REMS planning, writing and execution)
- Signal detection: qualitative and quantitative detection, analysis and reporting of signals
- Medical Information services