To enable India to become a global leader in clinical research.
To create, develop and nurture world-class clinical product development capacity in India.
The objectives as envisaged in the Memorandum of Association of CDSA are:
- To aid, promote, guide, strengthen and coordinate conduct of cost-effective services for technology-based (such as biotechnology) preclinical and clinical product development in India, which are relevant to the people in India.
- To undertake and implement cost-effective clinical research services as specified in point 1 above. For instance, projects involving new technology-based product development for government (such as biotechnology), semi government, government funded academic and non-academic institutions, non-profit and small and medium sized enterprises.
- To develop, supervise and coordinate a network of clinical trial sites (centres of excellence) in India with a fair geographical distribution of a suitable infrastructure, trained human resources and quality practices for suitable conduct of regulated clinical trials that meets the demands of the industry.
- To aid, promote, guide, strengthen, coordinate, undertake and implement human resource capacity building in India for preclinical and clinical development and other related activities with an aim to strengthen health systems and clinical research in India. CDSA shall ensure training of students and research professionals including physicians, involved in clinical research. And, provide onsite training to research professionals present at the trial sites linked to CDSA.
- To provide advice or consultancy as per the Department of Scientific and Industrial Research (DSIR) rules, in industry-related preclinical and clinical product development for industry, academia, public sector enterprises, SIBRI and BIPP.
- To network with relevant bodies in Government of India to facilitate and mentor innovation by aiding in framing of policies to enable promotion of clinical research and reducing barriers preventing the same.
- To promote the development of effective linkages/ collaboration on a continuing basis between various scientific and research agencies/ laboratories and other organizations working in the country and internationally in the field of preclinical and clinical research and related areas, to facilitate knowledge and maintain product development edge for Indian enterprises.
- To promote, establish (purchase and/or refurbish), maintain and manage clinical research sites.
- To promote, establish (purchase and/or refurbish), maintain and manage specialized research facilities with suitable infrastructure like laboratories, drug/investigational product storage, data management, for the efficient prosecution of scientific and technological research.
- To serve as a National Reference Centre for preclinical and clinical research.
- To receive donations, subscriptions and endowments for the purpose of society.
- To construct, maintain, improve, develop and alter any buildings, houses or other works necessary or convenient for the purpose of the society.
The objectives stated in the new proposal are:
The objectives of CDSA are:
- Enhance Academic Clinical Research Unit (ACRU) capability for clinical study support:
- To undertake and provide end -to- end clinical study support for investigators and SMEs in study design, planning, set up, conduct, analysis and reporting
- Build competent manpower resource within the core clinical trials teams: clinical science, data science, project portfolio management, regulatory science and biostatistics
- Build robust clinical trials/ studies IT infrastructure to provide clinical study and data management support services for clinical studies/ trials, large multicentre trials.
- Expand trials/ studies portfolio and ensure that these are done with highest ethical and regulatory standards
- Advise for regulatory approvals and pathway for product development
- Establish a network of Academic Clinical Research Units (A-CRUs)
Provide support for all stages of clinical trials including design, planning, initiation, conduct, data and safety monitoring, analysis and reporting
- Training academy:
- Build research capacity and capability through high quality training in the area of clinical development/trials and regulation
- Develop a niche in e-learning; with online courses
- Develop MSc in Clinical Research (with specialization in Clinical Trials) in collaboration with THSTI and RCB
- Develop ‘personnel certification scheme’ for GCP professionals; accreditation of training providers in collaboration with Quality Council of India
- Support and strengthen clinical research environment in the country
- Regulatory Science and Policy support:
To support CDSCO and other government, national and international agencies in developing policies/ documents
fostering collaboration with scientific, medical, national/international partner institutions and agencies.
- To recruit suitable human resource for realizing the mission of CDSA and implementation of various programs.
- To make CDSA financially self-sustainable.
- To work closely with THSTI and its various units to develop synergies in their activities.