End-to-end clinical research services in India — from early phase trials through post-marketing.
At Genelife Clinical Research, our mission is to drive innovation in drug discovery and development. With 16+ years of excellence and technological advancement, we provide comprehensive clinical research services in India for pharmaceutical, biotechnology, and medical device companies worldwide.
Full-spectrum Phase I–IV clinical research — operations, project management, site management, data management, biostatistics, medical writing, pharmacovigilance, and regulatory affairs for pharma and biotech companies globally.
Bioavailability and Bioequivalence study support including project management, site selection, regulatory submissions, and monitoring — with an established CRO network across India, Singapore, and the Middle East.
Real World Evidence studies, observational research, patient registries, post-marketing surveillance, and healthcare market research for evidence-based strategic decision-making across the product lifecycle.
GCP audits, SOP development, quality management systems, CAPA management, and regulatory inspection readiness for clinical research operations.
Protocol execution, site management, GCP monitoring, and compliance across all trial phases in India.
End-to-end coordination from feasibility through final study report — on time and within budget.
SAE reporting, signal detection, ICSRs, PSURs, DSURs, and CTD Module II preparation.
IND, NDA, ANDA, BLA submissions for CDSCO, FDA, EMA, TGA, and other global agencies.
EDC, CDISC SDTM/ADaM compliance, 99.9%+ data accuracy with validated audit trails.
ICH E9-compliant biostatistics, SAP writing, randomization, and final analysis reports.
One-Stop CRO in India: Genelife's defining characteristic is our ability to successfully manage and execute clinical research projects of all scales — from early phase pilot studies to large multi-centre pivotal trials — with quality, transparency, and efficiency.