Genelife Clinical Research Private Limited provides a comprehensive suite of clinical research services covering the entire drug development lifecycle — from Early Phase (Phase I–II) to Late Phase (Phase III–IV) clinical trials — as a leading CRO in India.
Genelife has made substantial investments in early-phase research, ensuring that foundations of groundbreaking therapies are laid with precision.
Genelife has established early-phase units within hospitals in India, Singapore, and Germany — offering direct emergency room access to subjects, ideal for Phase I studies requiring immediate medical intervention capability.
Systematic approach to site feasibility ensures chosen sites are well-suited for Phase I–II studies based on patient population, infrastructure, investigator experience, and regulatory track record.
Genelife has extensive experience conducting Phase III and IV clinical trials across diverse therapeutic areas.
Services include study design, protocol development, regulatory support, site management, data management, statistical analysis, and final study reports for pivotal regulatory submissions.
Post-marketing surveillance, long-term safety studies, and Real World Evidence studies supporting continued product monitoring after regulatory approval.
Protocol execution, site management, monitoring, and GCP compliance across all phases.
End-to-end project coordination with experienced PMs, defined SOPs, and sponsor reporting.
EDC systems, CRF design, data validation, CDISC compliance, and database lock procedures.
SAP development, biostatistics, randomization, and ICH E9-compliant analysis reports.
Protocols, IBs, CSRs, DSURs, and regulatory documents for global submissions.
SAE reporting, signal detection, ICSRs, PSURs, and comprehensive patient safety monitoring.
CDSCO, FDA, EMA submissions — IND, NDA, ANDA, BLA, and post-marketing requirements.
Genelife Clinical Research is a trusted CRO in India providing end-to-end clinical research services — from study design through regulatory submission — with quality, precision, and a patient-centric approach.