Clinical Pharmacovigilance Services
Genelife Clinical Research Private Limited maintains a steadfast Pharmacovigilance department dedicated to the meticulous preparation, review, approval, and reporting of all Serious Adverse Events (SAEs) reported during clinical trials and product development. Patient safety is non-negotiable in our operations as a CRO in India.
Pharmacovigilance Capabilities
- AE and SAE Logging, Tracking & Coding: Meticulous logging according to MedDRA/WHODrug standards ensuring data uniformity and accuracy across all clinical sites
- Safety/Medical Monitoring: Experienced safety monitors proactively identify and assess emerging safety concerns throughout the study lifecycle
- Medical Review of Data Listings: Comprehensive data listing reviews to uncover potential safety issues requiring clinical assessment or regulatory action
- Review of Medical Coding Data: Ensuring accuracy and consistency of all medical coding using current MedDRA and WHODrug terminology
- CTD Module II Preparation: Comprehensive overview of product safety and efficacy for drug approval — including clinical summary and clinical overview sections
- Individual Case Safety Reports (ICSRs): Detailed adverse event case compilation and reporting to regulatory authorities within required timeframes
- Expedited Reporting of SAEs: Prompt reporting of serious adverse events to regulatory authorities in compliance with CDSCO, FDA, and EMA requirements
- Periodic Safety Update Reports (PSURs) & DSURs: Regular comprehensive safety reporting to regulatory authorities covering the entire development lifecycle
Signal Detection
Systematic review of safety data to detect potential safety signals — using both qualitative and quantitative signal detection methodologies aligned with ICH E2C and E2E guidelines.
Risk Management
Development of Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and additional pharmacovigilance activities as required by global regulatory authorities.
Patient Safety First: All pharmacovigilance activities at Genelife are conducted with an unwavering commitment to participant welfare and full compliance with CDSCO, ICH E2A/E2B, and applicable global guidelines — ensuring maximum participant protection throughout every study as a trusted CRO in India.