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Our Objectives

Our main objectives at CDSA are:

  1. As a training academy, CDSA is mandated to build capacity and capability in the area of clinical development and translational research. We conduct training programs for young clinical researchers, ethics committee members and other personnel in becoming an efficient clinical research professional.
  2. 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 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
  • Reflexology for intractable epilepsy at clinical sites in NE region funded by DBT
  1. 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.
  • With BIBCOL, a public sector undertaking of DBT vaccine manufacturer for the bivalent OPV study in 1000 newborn.
  • CDSA is coordinating a phase 2 clinical study on verapamil in tuberculosis sponsored by NIRT, Chennai and funded by DBT.
  • Audited 13 sites for a Stem Cell Phase 2 Clinical Trial partially funded by BIRAC to a SME
  1. CDSA with 5 Centers of Excellence (CoEs) has formed a collegium of Centers of Clinical Research Excellence for collaboration in education, training and capacity building and Collaboration in Research, Innovation, and Clinical Development Support Services. The institutions are: KEM Hospital, Pune; Society of Applied Sciences (SAS), New Delhi; Center for Chronic Disease Control (CCDC), New Delhi; JSS University, Mysore and CMC Vellore.