Academy for Applied Research & Training in Healthcare in India
Academy for Applied Research & Training in Healthcare in India (aarth-INDIA) is an institution, registered under the West Bengal Societies Registration Act XXVI of 1961 of India, committed to foster and promote the cause of health sciences for the welfare of the people in India. It is a non-government initiative striving for attainment of better health of the community supplementing, and not substituting, the existing and future government systems and networks healthcare in India.
The non-availability, sub-optimal quality and relative lack of credibility of healthcare personnel and of the health-related data and information being as the two major impediments against optimum healthcare delivery in the country- aarth-INDIA pledges to bridge such gaps in its limited capacity.
Established in 2007 as a Kolkata-based registered organization, aarth-India undertakes self-sponsored and externally funded projects in research and capacity building in the areas of health and medicines. It also provides consultancy services in India in such areas in compliance with ethical norms and local regulatory requirements. As a part of its social commitment and obligation, the organization also engages itself in undertaking community-oriented and or institution-based projects of varied types on health care, health research and health services, on a not-for-profit basis and also extends support, intellectual and logistic, to different social and institutional/organisational initiatives benefiting the local communities. It coordinates and organizes short-term learning and training programmes for different target focus groups in the community and in institutions.
The conduct of clinical trials is a skill-intensive activity and requires a highly organised team approach. Knowledge and information management is at the heart of the current paradigm of clinical trial conduct. The different stakeholders of clinical trials include: the patients, the investigator and the site (institute), the ethics committee, the sponsor and the CRO (where applicable), and the regulatory agency. The conduct of trials in India is governed by the Indian GCP guidelines as well as the relevant regulatory provisions – Schedule Y that contains besides other things, the mandate for complying with the ethical norms. The Schedule Y has been recently amended in January-February 2013; such regulatory changes have made the issue very demanding for all the stakeholders in general and the ethics committee, in particular. Particularly big corporate hospitals that have been involved in the conduct of clinical drug trials in their premises now find it challenging to cope with the expanded regulatory mandates. There is an urgent need for continuous sensitization and capacity building of all stakeholders at the site, as well as meticulous implementation of the clinical trial projects conforming to relevant rules, norms and guidelines. Against this background, aarth-India offers to provide intellectual support and advisory services of general nature, towards smooth conduct of clinical trials at RTIICS, Kolkata. Expert consultancy services addressing diverse intriguing issues may be provided by aarth-India.