Medical Affairs And Pharmacovigilance

The Medical Affairs Department works closely with the project teams to provide comprehensive design and implementation support for Phase I-IV clinical trials, including Pharmacovigilance services. Our services cover the entire research process from protocol development and trials management through the preparation and finalization of clinical study reports for regulatory submission. Some of the specific services provided include:

• Participation in the development, writing and approval of clinical trial protocols, investigator's brochures and interim/final clinical study reports.
• Provide guidance to PIs and CRCs at study sites with regard to adherence to clinical trial protocols from clarification of inclusion/exclusion criteria, protocol deviations/waivers and overall conduct in the study.
• Provide support for the formation and management of Clinical Endpoint Committees, Data Safety Monitoring Boards and Steering Committees for clinical trials.
• Provide support for the evaluation and reporting of issues and serious adverse events related to product safety and efficacy.
• • Provide an SAE reporting phone line (e.g. 1-800 number) for initial reports from site
  • Prepare and review expedited SAE information for submission
  • Review pre-specified reported adverse events in clinical trials, assess, query and recommend corrections to MedDRA coding of adverse events. Approve MedDRA coding of adverse events.
  • Provide medical and scientific direction on clinical matters affecting preparation and submission of timely national and/or global regulatory safety reports.
  • Provide SAE narrative generation
  • Create and maintain SAE database
  • Prepare and distribution investigator alerts
  • Assistance in the preparation of periodic and other regulatory reports.
  • Serve as consultant to quality and medical vigilance functions in the investigation of adverse events and other product related issues
• Write review and approve manuscripts, abstracts, posters, slide presentations, and other documents to ensure appropriate evaluation and presentation of data, methodology, interpretation, and alliance with pre-specified objectives of the study.

The Medical Affairs department has also developed a 1 – 2 day course targeted for PIs and CRCs reviewing the responsibilities and conduct in clinical trials which can be tailored for study specific protocols.