Case processing & oversight

Pharmacovigilance and Drug Safety

How we can help

We’ll ensure that you focus on the opportunities

End-to-end programs.

This service is aimed at the understanding, detection, assessment, and prevention of adverse effects or any other drug-related problems. We set up monitoring & evaluation processes before drug & medication roll-out.

Aggregate reports

Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs).

Benefit-risk assessment

Data Safety

Data Safety Monitoring Board (DSMB) or Independent Data Monitoring Committee (IDMC) support.

Individual adverse event assessment

Signal detection and evaluation

Risk management

Risk management plans and pharmacovigilance strategy.