Pharmacovigilance Services

OCT’s Pharmacovigilance team covers a range of clinical trial safety monitoring and safety reporting tasks and responsibilities for our clients’ studies.

 

We coordinate and centralize all safety issues and all pharmacovigilance tasks to perform the management of safety information during the course of a clinical trial. Our expertise guarantees that all safety information (Serious Adverse Event  (SAE) and other cases) is collected and reported to the appropriate individuals and organizations within the required timelines on all studies we conduct for our clients.

OCT Pharmacovigilance services include:

  • Set up of PVG specific processes and procedures
  • Evaluation of safety data
  • Case receipt
  • Data entry
  • Adverse eventq triage
  • MedDRA coding
  • Narrative writing
  • Medical review
  • Quality control
  • CRF review
  • Reporting of SUSARs to regulatory authorities in all countries of OCT operation
  • Reporting of SUSARs to study sites
  • Preparation and submission of periodic reports to regulatory authorities in all countries of OCT operation
  • Preparation and submission of Annual Safety Report to study sites.

As a result, we bring together our PVG process expertise and the regulatory insights to deliver safety reports of high quality on time and in compliance with the sponsor’s budget.