Pharmacovigilance

We have a team of experienced safety officers managing all the safety issues related to clinical trials and post marketing services. The services comprise

AE/ SAE handling and electronic reporting in clinical trials and post marketing
Medical coding
Preparation of annual safety reports and Periodic Safety Updates (PSUR’s)
Preparation of risk management plans
Establishment of and participation in safety boards
Input to risk management plans
Supply of contract staff (e.g Medical Qualified Person)

Our services are based on Oracle AERS – Adverse Reporting system