Making registration compulsory for clinical trials will prevent the exploitation of medical research volunteers, for one…
The medical counterpart of the RTI (Right to Information) is here, and it has got teeth finally. Although the Clinical Trials Registry of India (CTRI) was launched by the Indian Council of Medical Research in July 2007, it’s only recently that the Drug Controller General of India (DCGI) ordained all clinical trials in the country to be mandatorily registered with the CTRI, with effect from June 15, 2009.
According to the World Health Organisation (WHO), “a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” Clinical trial research in the country, set to become a billion-dollar industry by 2010, is possibly helped to a large part by the fact of the nation’s sizeable population of the poor and diseased, but apparently there is more to it. Says Dr. Saurendra Das, Country Head & Director of Operations, Excel Life Sciences (ELS), “India has contributed to many US Investigational New Drugs (IND) over the last few years with highest number of enrollment, maximal retention and quality data; (there is) a competent investigator pool with access to large and diverse patient pool, trained support staff and recent modalities of diagnostic aids; proven and time-tested IT & ITES talent with experience in running state-of-the-art data management tools...”
Last month ELS, a US-based, India-focused clinical trial management organisation announced its partnership with PFC Pharma Focus, a Switzerland-based contract research provider, to launch PFC India as a full-service Contract Research Organisation (CRO), specialising in clinical monitoring and data management services.
The medical counterpart of the RTI (Right to Information) is here, and it has got teeth finally. Although the Clinical Trials Registry of India (CTRI) was launched by the Indian Council of Medical Research in July 2007, it’s only recently that the Drug Controller General of India (DCGI) ordained all clinical trials in the country to be mandatorily registered with the CTRI, with effect from June 15, 2009.
According to the World Health Organisation (WHO), “a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” Clinical trial research in the country, set to become a billion-dollar industry by 2010, is possibly helped to a large part by the fact of the nation’s sizeable population of the poor and diseased, but apparently there is more to it. Says Dr. Saurendra Das, Country Head & Director of Operations, Excel Life Sciences (ELS), “India has contributed to many US Investigational New Drugs (IND) over the last few years with highest number of enrollment, maximal retention and quality data; (there is) a competent investigator pool with access to large and diverse patient pool, trained support staff and recent modalities of diagnostic aids; proven and time-tested IT & ITES talent with experience in running state-of-the-art data management tools...”
Last month ELS, a US-based, India-focused clinical trial management organisation announced its partnership with PFC Pharma Focus, a Switzerland-based contract research provider, to launch PFC India as a full-service Contract Research Organisation (CRO), specialising in clinical monitoring and data management services.
Source : IIPM Editorial, 2012.
An Initiative of IIPM, Malay Chaudhuri
and Arindam Chaudhuri (Renowned Management Guru and Economist).
and Arindam Chaudhuri (Renowned Management Guru and Economist).
For More IIPM Info, Visit below mentioned IIPM articles.
Zee Business Best B-School Survey 2012
Prof. Arindam Chaudhuri’s Session at IMA Indore
IIPM IN FINANCIAL TIMES, UK. FEATURE OF THE WEEK
IIPM strong hold on Placement : 10000 Students Placed in last 5 year
IIPM’s Management Consulting Arm-Planman Consulting
Professor Arindam Chaudhuri - A Man For The Society….
IIPM: Indian Institute of Planning and Management
IIPM makes business education truly global
Management Guru Arindam Chaudhuri
Rajita Chaudhuri-The New Age Woman
IIPM B-School Facebook Page
IIPM Global Exposure
IIPM Best B School India
IIPM B-School Detail
IIPM Links
IIPM : The B-School with a Human FaceProf. Arindam Chaudhuri’s Session at IMA Indore
IIPM IN FINANCIAL TIMES, UK. FEATURE OF THE WEEK
IIPM strong hold on Placement : 10000 Students Placed in last 5 year
IIPM’s Management Consulting Arm-Planman Consulting
Professor Arindam Chaudhuri - A Man For The Society….
IIPM: Indian Institute of Planning and Management
IIPM makes business education truly global
Management Guru Arindam Chaudhuri
Rajita Chaudhuri-The New Age Woman
IIPM B-School Facebook Page
IIPM Global Exposure
IIPM Best B School India
IIPM B-School Detail
IIPM Links
