Varsha Gore

Clinexel Life Sciences Pvt Ltd

CLINEXEL is a full service CRO providing end to end services for Clinical Research and Pharmacovigilance. We are working with NCEs & Biologicals, conducting Phase 1, 2 & 3 clinical trials. We are providing end to end services-regulatory approvals, site selection, monitoring, logistics & CT supplies, patient recruitment strategies, data management, statistical analysis & CSR writing. Medical Device Projects at CLINEXEL include PMCF studies & writing Clinical Evaluation Reports (CERs) as per EU MDR for CE marking and renewals. CLINEXEL Pharmacovigilance (PV) team is providing end to end PV services to CLINEXEL clients, including case processing, preparation of periodic reports, signal detection, worldwide & local literature monitoring, QPPV services, development and maintenance of PSMF and GVP audits. WE have extensive experience in regulatory inspections (USA and Europe) and Client audits. WE are a team of 20 qualified, trained and experienced professionals (Physicians and Pharmacists), delivering high quality Clinical Research, Pharmacovigilance and Medical Writing services. We are based in India and provide services to our Clients from across the Globe. Our clients are small and mid-size Pharmabiotech and Medical Device companies from various countries including the USA, Europe and UK. CLINEXEL Clinical Research team has a strong understanding of ICH-GCP, Indian regulations- NDCTR-2019, and extensive monitoring experience with clinical trial sites and investigators in India. CLINEXEL is a member of AICROS (www.aicros.com) and through AICROS and its members, we have the capabilities to conduct cost efficient Global Clinical Trials for our clients while ensuring the high quality and local expertise in each region. Our expertise includes development and execution of cost and time efficient Global Clinical Development strategies for New Chemical Entities, Biosimilars and Complex Generics.