Clinical Development Services Agency (CDSA)

About CDSA

Clinical Development Services Agency (CDSA)is an extramural unit of THSTI and has been established as a not-for-profit society to provide cost affective, high quality preclinical and clinical product development support services to meet the country’s growing healthcare needs. It will tend enterprises; particularly SMEs involved in new technology innovation and facilitate translation of scientific know-how into viable products.

The early focus of the CDSA mandate is to promote the enhancement of clinical trial capacity in India as per international standards. Thiswouldentail (a) developing Centres of Excellence (COE) in clinical research through partnerships with leading institutions conducting clinical trials in India (b) providing comprehensive and sustained training in clinical research through these COE in order to build a cadre of world class investigators capable of conducting clinical trials for regulatory submissions.

Two main streams of training have been identified, viz., (i) drug discovery and translationalmedicine – to cover preclinical research from conceptual chemistry/molecular biology to early clinical development, and (ii) training in clinical trials for regulatory submissions. For the first stream, partnerships are being envisagedto implement this program as a post-graduate diploma/degree course for students. For the clinical trials program,at least five leading clinical research institutions are being identified across India to serve as potential partners for COE development.

Planned Activities

The following initiatives are proposed by CDSA:

  • 1. Enter into long-term alliances and partnerships both for the purposes of establishment of centers of excellence and for training in clinical research..
  • 2. Assess clinical research and management training needs at research sites to implement a training curricula forprincipal investigators, research managers, administrators and others from the sites that will strengthen the capacity of investigators. The curriculum will encompass clinical research training and research management training.
  • 3. Provide the services of data management and biostatistics from a central facility in NCR to support regulatory trials being carried out at the centers of excellence.
  • 4. Facilitate the formation of IRBs/IECs to ensure that the conduct of regulatory trials meets the requisite ethical standards..
  • 5. Conduct clinical trials with vaccines and/or diagnostic products for public health diseases.

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