We offer our services both during clinical development and post-marketing. They can be provided as a complete solution or as stand-alone services.

Pharmacovigilance System

Detailed description of the pharmacovigilance system
Standard Operating Procedures (SOP’s)
Safety Database
Safety Data Exchange Agreement
EU Qualified Person for Pharmacovigilance (QPPV)
EU depute QPPV
24/7 Medical support

Operational Services

Case handling (triage) of adverse events (AE) and adverse drugs reaction (ADR’s) during clinical development and post-marketing
Periodic reports (PSURs/PDERs/DSUR)
Medical literature search
Generation of CIOMS I/ MedWatch forms
Expedited reporting till Eudravigilance
Call center services that handle medical information, and AE/SAE case intake

Specialist services

Risk Management Plan (RMP)
Risk Benefit Analysis
Signal Detection (analysis and trending of cases)
Signal Evaluation

Support Services



Outsourcing of pharmacovigilance consultants

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