Pharmacovigilance

Agati Clinical offers a comprehensive range of pharmacovigilance services essential for the conduct of clinical trials

  • Case Processing

  • Literature case review

  • Case submission (electronic and paper)

  • Safety writing, risk management and signal detection

  • Author periodic reports (IND AR, NDA PR, PSUR, PADER, ASR)

  • Summary, bridging and ad-hoc reports

  • Annual & ad-hoc safety signal evaluations