ADR / SAE Reporting

Pristyn Research Solutions

ADR / SAE Reporting

Clinical trial study of drug usually identifies common Adverse Drug Reaction (ADR) but, the reaction which occurs after long duration in a particular person or population remains undetected. Pharmacovigilance (PV) is a scientific activity which has constant watch on the drug during its life cycle. In India, Indian Pharmacopoeia Commission (IPC) and National Coordination Committee (NCC) through the Central Drug Standard Control Organization (CDSCO) cordially control the PV activity. To form a possible PV system in India, Pharmacovilance Program of India (PvPI) have been planned and applied by the Indian government in 2010. The precise finding and reporting of ADR is a heart of this system. Hence various regional, territorial and peripheral centres have been proposed for the smooth and effective reporting of ADR. Anybody can report ADR by filling the suspect ADR reporting form accessible online or offline to the nearest centre in suitable language. As Indian geographical distribution, vast population and mobile network connectivity, a toll free number and the mobile app is also provided for timely and effective reporting of ADR. The reported ADRs are collected and managed at the centres in Vigi-flow software. These centres detect signal which are reported to CDSCO and World Health Organisation (WHO) for the additional regulatory action. CDSCO-WHO communicates their decision through a suitable media for the improvement of public health.

Pristyn research team has expertise in authoring content, coordinating reviews, catering quality checks, and periodic safety reporting and aggregate reporting services in pharmacovigilance (PV) for various HAs. With a complete knowledge of worldwide PV process and safety obligations, strategic level maintenance activities are planned and executed as below :

  • Tracking and managing preparation of reports based on reporting time period and database lock
  • Submission to HA
  • Compliance to HA timelines
  • Handling and responding to HA queries
  • Reporting and monitoring Adverse Drug Reaction (ADR)
  • Reporting Serious Adverse Event (SAE)