Shalini Dhiman's Contact Details

Shalini Dhiman's Company Details

Clinexel Life Sciences Pvt Ltd

Navi Mumbai, Maharashtra, India • 25 Employees
Pharmaceuticals

CLINEXEL is a rapidly growing Clinical Research Organization. WE are a team of 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, Medical Device Regulations, basics of Clinical Development 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.CLINEXEL Pharmacovigilance team is providing end to end pharmacovigilance services to CLINEXEL clients, including case processing, preparation of periodic reports, signal detection, worldwide & local literature monitoring, QPPV services, development and maintenance of PSMF. TEAM has extensive experience in regulatory inspections (USA and Europe) and Client audits.CLINEXEL Team has been supporting Medical Device companies for developing Post Marketing Clinical Follow-up (PMCF) plans, conducting medical device trials as per PMCF plan and preparation of Clinical Evaluation Reports for CE Marking and registering the medical devices in other regulated markets.