Pharmacovigilance

Pharmacovigilance

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At MAC, our pharmacovigilance (PV) activities are delivered in full compliance with Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and all applicable national regulatory requirements. This rigorous quality framework ensures early phase sponsors receive dependable, inspection ready safety oversight that protects trial participants and supports the evolving risk–benefit understanding of their investigational product.

As a CRO highly experienced in early clinical development, we provide an integrated PV service model designed to give sponsors complete confidence that all safety monitoring, processing, and reporting obligations are fulfilled to the highest standard.

We establish the essential safety framework required for early‑phase studies, including:

  • Safety Management Plans (SMPs) tailored to early‑phase risk profiles and operational needs
  • Pharmacovigilance database configuration appropriate for first‑in‑human (FIH) and exploratory clinical studies
  • Processing SAE/SUSAR reports: case intake, collation, follow‑up, medical review, and validated safety narrative development
  • MedDRA coding, case closure, and secure case file archiving
  • Assessment of reportability for global regulatory authorities
  • Submission of reportable events to regulators, ethics committees, and investigator sites (PIs)
  • Creation of summary tabulations and line listings
  • Preparation of Annual Safety Reports (ASRs)/Development Safety Update Reports (DSURs)

 

These deliverables help sponsors proactively understand emerging safety trends, meet global regulatory timelines and maintain continuous oversight of participant safety helping them to confidently advance to later phases of drug development.

Why Sponsors Choose Us

  • Quality‑driven PV framework and integrated medical and safety expertise enabling rapid response, proactive decision‑making, and clear communication.
  • Confidence that all safety monitoring and reporting expectations will be met from first participant in (FPI) through study close‑out.