GCP Compliance &Clinical Trial Subject Protection Program for Global Healthcare Industry

Online, December 2, 2010 (Newswire.com) - It is an established Absolute Truth that 'Health is Wealth' and hence one of the most important task for the Healthcare Providers/Promoters ; Viz Government Agencies,Hospitals,UN bodies like WHO,UNICEF,GAVI Alliance,HHS/NIH,NHS etc is to support the R&D endeavours for New Drug/Device Discovery by Pharmaceutical,Medical Device,Biotechnology companies,Global Voluntary/Non Profit Organisations etc.But New Drug Discovery is one of the most difficult Herculian task for the R&D Stakeholders for various reasons;the cost to produce a new drug is increasing exponentially year by year,most of the Trials end up being futile and there are many issues and time delays in completing a Clinical Trial.Since one of the most effective way to ensure hassle free and hurdleless Clinical Trial Process is by promoting Strict GCP Compliance at every level of Clinical Trial conduct,Helix Research Center has taken initiative to launch 'GCP Compliance and Clinical Trial Subject Protection Program' for the Clinical Research stakeholders Worldwide.This Program is nothing but a 'Master Training Program' especially for the Hospitals where the Clinical Trials are conducted and Clinical Research Investigators,so as to decipher and adhere to GCP Compliance and create awareness amongst the masses on various aspects of Clinical Trial Process pertinent to Human Subjects participating in a Trial.

Ever since the Government agencies to Regulate Clinical Research have been formed by various countries across the globe,the Dilemma whether or not to approve an IND-Investigational New Drug Application has invariably been causing 'Tremendous Strain' for these bodies.The reason is very simple-the Regulatory Authorities have to promote Research and Development (R&D) endeavours by various companies/Organisations and the same time they need to ensure Protection of Human/Animal Rights,Safety and well being of Clinical Trial participants.Hence the Regulatory Authorities are 'Constrained ' to issue strict Guidelines for conducting Biomedical Research and also carry out Audits/Inspections.The measures initiated by various Regulatory Bodies are invariably 'Misinterpreted'by some members of 'Fourth Estate',the Clinical Trial Sponsors and Researchers around the World.Likewise,the R&D endeavours of Global Biopharma,Biotech companies etc are invariably labelled as 'Commercial';which is very unfortunate.No Pharma or Biotech/Device company would like to introduce a New product that can cause 'Harm' to the Society.In view such unpleasant scenario prevalent in the Global R&D/Clinical Research Arena ,there is a dire need to break the 'Shell ' called 'Ignorance is Bliss' and find a Solution for Promoting R&D and Protecting Trial Subjects as well.This is possible only by 'Making the Mind know so that the Eyes can see'.

Though International Conference on Harmonisation-ICH was formed by United Sates,Japan and Europe to 'Harmonise' the Clinical Trial Process in this Region and World in General,and World Medical Association has been making necessary amendments,in line of Evidence based Medicine,HHS,NIH,WHO,FDA,EMEA etc have been publishing Guidelines for conducting Clinical trials,the 'Interpretation of GCPs' is yet to be 'Harmonised' Pan World.

The GCP Compliance & Clinical Trial Subject Protection Program will be available for various Primary,Secondary and Tertiary Care Hospitals around the World,Newly formed Ethics Committees,Doctors/Principal Investigators/Co Investigators,Sub Investigators,Senior Clinical Research Professionals etc .The Training will be conducted in different modes such as Onsite,Web based Live,Online ,through TV Channels etc by Senior Clinical Research Professionals of International Repute.

Helix Research Center is keen to get associated with Professional Societies,like minded Individuals/Groups to Promote Ethical Clinical Research and Healthcare of the Society,rising above Competition and Conflict of Interest.