Clinical trials in India provide an opportunity to accelerate the drug development process. The Union Ministry for Health and Family Welfare has notified the Drugs and Clinical Trials Rules, 2019 with an aim to promote clinical research in the country.
The new rules aim to promote clinical research in India by:
- Providing a predictable, transparent and effective regulation
- Ensuring faster accessibility of new drugs to the Indian population
India has well established subject expert committees operating across all therapy areas. There are more than 1000 Ethics Committees currently working in India and conducting more than 4000 clinical trials.
Pharmaleaf: Clinical Trials
Our Clinical Team is solution oriented and delivery driven and provides end-to-end Regulatory and Technical Project Management Services for Clinical Trials in collaboration with qualified Affiliates.
Pharmaleaf has worked largely with global clients in providing Clinical Trail Site management for their clinical trials. Our facility has been audited by all our sponsors.
- Procurement of import license
- Customs clearance of import shipment
- Receipt of inward bulk shipments
- Management of local shipments to sites
- Storage of investigational product (cold storage) and other trial supplies
- Inventory management (Reconciliation and destruction of IP)
- Coordination with local couriers
- Site Management Services (Study Set-up, Study Conduct and Study Close-out)
- Post Approval (Amendments - Major, Minor, Notifications - Major, Minor)
- Pharmacovigilance - SAE reporting, Data Management, MIS Maintenance, Archival and License Maintenance.
- Pharmaleaf have its own Pharmacovigilance (PV) cell which will be monitored by qualified medical practitioners on regular basis.
To know more about our PV services, please click here.