Individual Case Safety Reports (ICSR)
Intake, triage, data entry, coding, medical review and expedited submission of adverse event cases.
Our services
Pharmacovigilance
Patient safety does not stop at approval. We provide scalable pharmacovigilance services for investigational and marketed drugs, biologics, devices and combination products, helping you detect, assess and minimize risk while staying compliant.
Service Areas
Literature Monitoring
Global and local literature screening to identify reportable safety information.
Aggregate Reports
PSUR/PBRER, DSUR, PADER and other periodic safety reports.
Signal Management
Signal detection, validation, evaluation and documentation.
Risk Management
Risk management plans, REMS support and additional risk minimization measures.
QPPV & PSMF
Qualified Person for Pharmacovigilance services and Pharmacovigilance System Master File creation and upkeep.
Medical Information
Handling of medical enquiries and product complaints from healthcare professionals and patients.
Clinical Trial Safety
AE/SAE management, SUSAR reporting and safety oversight for ongoing trials.
Let’s work together
Scale your safety operations with a specialist team.
Tell us about your program and our experts will get back to you with a tailored approach and proposal.