We offer 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 at Reliance 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 & 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)
  • Development 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 & conducting Post Marketing Safety (Phase IV) studies & safety data collection
  • Site safety audits for compliance
  • Management of safety issues associated with Medical Devices & Product Technical (Quality) Complaints
  • Medical literature search for regulatory submission
  • Training Sponsors / Investigators in Safety reporting infrastructure & processes