Indegene recognizes pharmacovigilance and safety as key areas of strategic partnership as we create dedicated CoE programs that mirror the sponsor organization.
For more than a decade, Indegene has been supporting the pharma, life sciences, and medical device companies as a strategic scientific partner offering large-scale offerings in medical call center management, literature searches (safety searched), events coding, safety narrative writing, and coordinating closely with the regulatory bodies across the world. Indegene stands apart as a pharmacovigilance and safety partner to its clients by aligning services and adding risk management consulting and signal detection through strategic partnerships.
Literature Search/Safety Searches
Signal Detection and Analysis
Benefit-Risk Evaluation Reports
Safety Assessment Reports
SBR/PSUR Addendum/Addendum CO
Clinical Summaries: SCS/ISS/SCE/ISE Reports
Clinical Overviews: Renewal COs, Labeling Justification Document, ADR Frequency and Category CO and Article 46
Response to Health Authority Queries
Health Hazard Assessment Report
Legacy Report Conversion and Reconciliation