Businesses - Clinical Research Services - Services - Pharmacovigilance


Reliance Life Sciences offers a basket of services related to Pharmacovigilance across all phases of clinical development and post approval through a team of dedicated and experienced Pharmacovigilance associates and Medical Monitors (Physician).

Pharmacovigilance services offered are:

  • Study and Sponsor specific
  • Dedicated Pharmacovigilance associates
  • 24 x 7 receipt and processing of Serious Adverse Events (SAEs)
  • Capability to enter data directly into Sponsor's safety database
  • Rapid medical and regulatory assessment of SAEs for reportability
  • Established pharmacovigilance follow-up and management practices
  • Timely transmission of safety issues to sponsors, regulatory affairs and Ethics Committee (EC)/Institutional Review Boards (IRBs)
  • Liaison between investigators and medical monitors at sponsor groups across varying regions and time zones
  • Coding of medical terms and medications using MedDRA & WHO-DD
  • Preparation of SAE case narratives
  • Preparation of Periodic Safety Update Reports (PSURs)
  • Preparation of risk management plan
  • Dedicated medical monitoring team which is available 24 x 7 for support to the Investigator and the operations team during the conduct of a clinical trial
  • Designing and conducting post marketing safety (Phase IV) studies & safety data collection
  • Site safety audits for compliance
  • Management of safety issues associated with medical devices and product technical (quality) complaints
  • Medical literature search for regulatory submission
  • Training sponsors / investigators in safety reporting infrastructure and processes