|
Clinical Development Services Agency
|
The Clinical Development Services Agency (CDSA) was launched in September, 2009 as an extramural unit of Translational Health Science and Technology Institute (THSTI), an Autonomous Organisation of Dept of Biotechnology, Ministry of Science and Technology, Government of India, was created to facilitate development of affordable healthcare products for public health diseases. Registered as a not-for profit research organisation, it aims to develop an eco-system for training and learning and work with public sector institutions, and small and medium enterprises (SME) to translate innovative technologies into medical products for public good. Registered in September 2010 as an autonomous, not-for profit research society by the Registrar of societies, Delhi, under the Societies Registration Act XXI of 1860, it aims to develop an eco-system for training and learning and work with public sector institutions, and small and medium enterprises (SME) to translate innovative technologies into medical products for public good. CDSA has a simple governance structure. Led by a high-powered Governing Body, it has 12 members including the Programme Director, Dr. Sudhakar Bangera who acts as Member Secretary. The operational oversight of CDSA is provided by an Executive Management Committee (EMC) that comprises of experts in training, product development, and organisational development among others. Main objectives of CDSA and the work done so far: * As a training academy, CDSA aims to build capacity and capability in the area of clinical development and translational research by conducting training programmes for young clinical researchers, ethics committee members and other personnel in becoming an efficient clinical research professional. * Monitor public health studies for compliance to Schedule Y regulations, CDSCO-GCP guidelines, Study Protocol and other requirements. * Support Investigators and SMEs by providing Clinical Study Support Services like regulatory consultation, project management, medical monitoring, audit, data management and biostatistics * CDSA with 5 Centres of Excellence (CoEs) has formed a collegium of Centres 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; Centre for Chronic Disease Control (CCDC), New Delhi; JSS University, Mysore and CMC Vellore. Till 2016, CDSA has completed 17 trainings covering approximately 1329 participants with 181 resource personnel involving 155 attendees from institutions across India. More than 3003 participants from 423 Institutions have attended 49 trainings that involved 494 resource personnel.
|
|
|