Since the Research Personnel in the OECD Countries are thorough with the various Guidelines pertaining to Clinical and Non Clinical Research ,Viz-Declaration of Helsinki by World Medical Association,International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidelines,WHO Ethical Standards and Procedures for Research With Human Beings,International Ethical Guidelines for Biomedical Research Involving Human Subjects by Council for International Organisations of Medical Sciences (CIOMS),Human Rights/Bioethics by United Nations Educational,Scientific and Cultural Organisation (UNESCO),Council Europe Bioethics Convention,OECD Biobank Guidelines,Guidelines and Regulations of Regulatory bodies of Member states,the Pharmacovigilance by Uppsala Monitoring Centre (UMC),the Protection of Human and Animal Rights and safety and well being of Trial subjects is assured and Quality Data generated during Clinical/Non Clinical Trials facilitates quicker Regulatory Approvals for introduction of new Medicines to the market.The 'Mutually Acceptable Data' (MAD) System introduced by OECD is one its Milestones that has Harmonised Good Laboratory Practices (GLP) across the Globe and saved time and money as well.
The Sophisticated Healthcare system in the OECD Countries provides excellent Central Lab and sample storage facilities.The highly skilled Doctors and the support staff can handle any Adverse Events/Severe Adverse Events and facilitate reporting of the same to Regulatory Authorities/
It is an established truth that despite being developed economies and striving hard to ensure better quality of living;various forms of Cancers,Cardiovascular Diseases,Disorders of Nervous System,Mental disorders,Chronic Respiratory Diseases,Diabetes,Road Traffic Accidents,Musculoskeletal Disorders,Genito Urinary diseases,Digestive system Disorders,Infectious/
Due to recommendations of various experts,Professional Associations,Academia,Government Committees etc,the Process to Harmonise and Globalise Medical/Clinical Research has taken a momentum since a decade and the OECD Region provides 'Globalised' Clinical Trial environment indeed.The 'Expedited Review' System introduced by various Regulatory bodies in this region encourages the Clinical Trial Sponsors to plan and place many Global Trials
Helix Research Center has an expertise to provide entire spectrum Therapeutic as well as Scientific Research Services within the purview of the Rules and Regulations Pan OECD Region.Since various Government bodies/officials are always ready to render support for any Enterprise/Entrepreneur working hard to add some value to their community,the Management of Helix Research Center has a strong desire and Vision to establish World Standard Healthcare and Research facilities in this region.Since,ensuring strict GCP Compliance is most important than the Experiment/Science itself,Clinical Trial related issues continue to hit the Headlines of News Papers,TV and other electronic media almost everyday,there is a dire need to find a way to avoid Controversies pertaining to Biomedical Research activities in any part of the World.Since many UN bodies such as WHO,UNESCO and Non Governmental bodies associated with UN/WHO such as CIOMS ,Council of Europe,etc are playing a Key Role in promoting R&D,Healthcare etc,Helix Research Center makes a suggestion for creating a 'Scientific Committee' to review any Clinical or Non Clinical Protocol,much before an Investigational New Drug Application (IND) is filed by the Sponsor.Every Member of such a Scientific Committee will sign the CDA/NDA and hence there will not be scope for Breach of 'Confidentiality'.Thorough review of the Protocol by the highly qualified Members of the Committee might help the Sponsors,Regulatory Authorities to avoid Clinical Trial related embarrassment and Protect the Clinical Trial subjects by avoiding Adverse Events/Thalidomide like Disasters!
Helix Research Center is always keen to work with like minded Individuals,Groups,Associations,NGOs,etc to promote New Drug Discovery,Preventive&