- About Us
- CLINICAL STUDY SUPPORT SERVICES
Department of Biotechnology
Ministry of Science & Technology
Government of India
Clinical Study Support Services
CDSA collaborates with Government Agencies and Institutions, Academic Institutions, and Small and Medium Enterprises (SMEs) in Pharmaceutical, Biotechnology and Medical Device sectors in coordinating and/or implementing their clinical studies. CDSA would be happy to collaborate in the following areas:
1. Regulatory Affairs
Dossier Review before submission to DCGI or other Agencies
2. Project Management
3. Technical Advisory Support for Projects
- Review of Study Protocol for compliance to Regulatory and appropriate Guidelines
- Review of Study-related Documents
- Review of Study Design through Peer Review
Review of Clinical Study Report
4. Clinical Monitoring
- Site/Investigator Feasibility/ Assessment
- Study/Site Initiation
- Interim Monitoring
5. Clinical Data Management
7. Audit of CRO, Clinical Laboratory and Clinical Study on GCP and GLP
8. Establish Data & Safety Monitoring Board
9. Collaborate with Researchers/Applicants for Grant Application
So far, CDSA has collaborated with Investigators and SMEs in the following areas:
Monitor public health studies for compliance to Schedule Y regulations, CDSCO-GCP guidelines, Study Protocol and other requirements. CDSA has been monitoring the following studies:
- Monitoring 3 Severe Acute Malnutrition (SAM) studies that been funded by DBT, Indian Council for Medical Research and Bill & Melinda Gates Foundation.
- Monitoring the Preterm Birth study funded by DBT
- Audited 13 sites for a Stem Cell Phase 2 Clinical Trial partially funded by BIRAC to a SME.
AIIMS lead study, Reflexology for intractable epilepsy at clinical sites in NE region.
Support Investigators and SMEs by providing Clinical Study Support Services like regulatory consultation, project management, medical monitoring, audit, data management and biostatistics. CDSA is supporting the following programs.
- In collaboration with AIIMS (coordinating site) and 11 other medical institutions across India for the surfactant study in 900 preterm babies, an innovative molecule developed by AIIMS, technology refined by Cadila Pharma and study funded by Wellcome Trust for approximate Rs. 12 Crores. Project awaiting DCGI approval since October 2013.
- With BIBCOL, a public sector undertaking of DBT vaccine manufacturer for the bivalent OPV study in 1000 newborn. Project awaiting financial approval from DBT and BIBCOL.
- CDSA is coordinating a phase 2 clinical study on verapamil in tuberculosis sponsored by NIRT, Chennai and funded by DBT.
- CDSA supports the projects in coordinating the data through Promasys, a clinical data management software application and will provide guidance on regulatory requirement, biostatistics, medical monitoring and coordinating DSMB activities.