At Tech Observer our Pharmacovigilance and Drug Safety group is dedicated solely to collecting, interpreting and reporting safety events on behalf of clients after their products are approved for marketing covering a broad spectrum of therapeutic areas. Our services span the life cycle of marketed medical products, including pharmaceuticals, biologics and medical devices.
Individual Case Safety Reports (ICSRs)
Periodic Safety Update Reports (PSURs)
Annual Safety Reports (ASRs)
Summary Bridging Reports (SBRs)
Scientific Literature Surveillance
SAE Management and Reconciliation
Case Narrative Writing
Medical Coding
Safety Signal Detection
Epidemiology Consultation
Risk Management
Regulatory Consultation
