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All pharmacovigilance activities conducted by MAC are performed in accordance with Good Clinical Practice (GCP), Good Pharmacovigilance Practice, and all relevant national legislation and regulations for the countries in which the study is to be conducted. This highly regulated service ensures compliance with advanced quality standards and providing complete confidence that the safety monitoring and reporting requirements of your trial are met.

We are responsible for:

  • Preparing Safety Data Exchange Agreements (SDEA) and the Safety Management Plan (SMP)
  • Developing and managing a pharmacovigilance database configuration
  • Processing SAE/SUSAR cases, including collation, management, follow-up, medical assessment, safety narrative writing,
  • MedDRA coding, case closure and case file archiving
  • Assessment and evaluation of reportability, and submission of SAE cases to global regulatory agencies, ethics committees, and principle investigators (PIs)
  • Creation of periodic summary tabulations and line listings
  • Preparing development safety update reports (DSURs) and annual safety reports (ASRs)