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