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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

Audits
CAPAs
Training

Outsourcing

Outsourcing of pharmacovigilance consultants

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