Case Report Management


Mediscribe Clinical Team (MCT): Experienced safety specialists and supervising physicians manage the SAE, including triage, processing, quality review, medical review, analysis of similar events, reporting and query management processes that identify SINDIAARS and enable on-time reporting to regulatory authorities, investigators and IRBs/ethics committees.

Mediscribe Pharmacovigilance Team (MPT): MPT includes call center surveillance team handling product complaints and adverse event (AE) receipt, and client focused dedicated team that receives serious and non serious cases, triage, case entry and follow-ups, narrative writing, quality reviews and medical reviews to enable on-time reporting to regulatory authorities.

Our Core :

  • Receiving, processing and archiving adverse events and reaction information
  • Medical assessment of individual cases
  • Preparation of SAE case narratives
  • MedDRA coding and coding convention strategies
  • Medical support for SAE reconciliation
  • Maintaining compliance with local and international requirements
  • Preparation of standard operating procedure documents and guidance documents