To help manage and execute its services, the Clinical Development Services Agency (CDSA) of the Department of Biotechnology (DBT) will soon form a consortium with five associate organizations.

The overall aim of the collaboration is to enable indigenous development of affordable health technologies and train manpower in reliable ethical and clinical research requiring regulatory approval. The partners need to be esteemed departments, units or centres of institutions or organizations governed through an autonomous society or a section 25 company recognized by Department of Scientific and Industrial Research (DSIR).

The consortium will work in an autonomous manner, build collaborations nationally and globally and emphasize low cost health care product development. The CDSA partners will maintain their independence to provide and execute their services in areas that are not under the mandate of CDSA.

The DBT has invited proposals from eligible institutions in this regard. They should have a designated leader with an established academic and product evaluation reputation and a team of at least 3-4 full time researchers and other experienced and accredited clinical research professionals. The researchers should have research publications in peer reviewed journals and experience of attracting independent grants from national/international agencies.

The organization should have experience in conducting preclinical and/or phase II-IV clinical product development trials (including population-based studies/field trials) for vaccines, drugs, medical devices and other biopharmaceutical products and should also have been successfully audited by international agencies for compliance to ICH/GCP.

The partners shall enter into an initial agreement for a minimum duration of 5 years extendable for 5 years intervals. CDSA shall provide ongoing support to the partners towards capacity building, training & maintenance of key personnel and improving infrastructure for the services provided by them keeping in mind global best practices for ethical evaluation of health related products. In return, the partners shall be responsible for preferential conduct of project-related services being executed by CDSA for which the expertise and ability resides with them and to contribute to human resource development activities like participating in a national program to train and nurture Principal Investigators in clinical research and trials with regulatory implications.

The DBT has launched the high quality preclinical and clinical product development support service called CDSA for SMEs and other relevant bodies as an extramural centre of Translational Health Science & Technology Research Institute (THSTI) in the National Capital Region.

This Agency will provide a supportive and focused environment to host quality ethical clinical translation through a collaborative network of clinical research sites (Centres of Excellence). It will tend enterprises, particularly SMEs, involved in new technology innovation and facilitate translation of scientific know-how into viable and affordable products of maximum public good. CDSA will also undertake aid and promote training duly accredited by an appropriate body in preclinical and ethical clinical product evaluation.