Nov. 12, 2012
-- With a Vision and ambition to provide Contract Research Services for the Pharmaceutical,Medical device,Cosmetic and Biotechnology companies in All the countries of the World,to utilise the expertise of local stakeholders,to nurture the talent of Global Clinical Research Fraternity,to reduce the overheads to expedite the Pre-Clinical /Clinical Trials as much as possible and to contribute their share for the ' Global Campaign to Harmonise the Interpretation of Good Clinical Practices', the management of UK based MNC Helix Research Center Ltd have launched 'Transworld CRO and SMO Alliance'. Moreover,since the 'Request For Proposals'(RFPs)
being received by Helix Research Center are invariably Multinational,Multicentric Clinical Trials with high expectations by Sponsors for early completion of studies and strict GCP ( Good Clinical Practices) and GLP ( Good Laboratory Practices) Compliance including reduced timelines for Regulatory Approvals,senior members of Helix CRO services teams believe that functioning through same Standard Operating Procedures ( SOPs) with slight deviations whenever required and merging their expertise with local Contract Research Organisations (CROs ) and Site Management Organisations (SMOs) is the most viable option .
It is imperative,implementing the concept of ' Transworld CRO and SMO Alliance' is a Herculian task as the Guidelines and Regulations Governing Biomedical Research are not the same Pan World except in ICH (The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) probably ICH GCG ( ICH Global Cooperation Group) RHI ( Regional Harmonisation Initiative) such as APEC (Asia Pacific Economic Cooperation)
, ASEAN PPWG ( Association of Southeast Asian Nations Pharmaceutical Product working Group), EAC (East African Community ) ,GCC (Gulf Cooperation Council), PANDRH (Pan American Network for Drug Regulatory Harmonisation)
, SADC ( South African Development Community ) countries.Nevertheless,the senior team of Member of Helix's CRO services teams and their advisors possess vast experience in the International Clinical Research arena to successfully implement the concept being launched Pan World.
As many may agree ' there are many paths to the top of the mountain ,but the view is always the same' , and if the 'Top of the Mountain ' is R&D ( Research and Development)
or New Drug Discovery,the perceptions of R&D Scientists,Regulatory Authorities,Health Policy Makers,Journalists,Human Rights Organisations,Research Sponsors etc may be different ,but the 'View' ,the common goal is the same; Viz (that is ) Protection of Human/Animal Rights,ensuring Safety and well being of Clinical Trial Subjects etc whilst introducing new Medicines and Methods of treatments for the Ruthless,Fatal diseases causing mortality and morbidity in the Global Community.If New Medicine,Vaccine or Medical device drug Discovery/Invention was not most Essential or Indispensable Scientific activity,Clinical Research would not have been a stable Industry for more than a Century.Hence,there is a need for each and every country in the World to actively promote Medical Research and assist the efforts of UN bodies like WHO to accomplish Health For All Vision.
With regard to implementation of their Concept of Transworld CRO and SMO Alliance ,the Policy makers of Helix Research Center opine,not all the CRO activities could be carried out through their partners. Support Services such as Pharmacovigilance,Clinical Data Management,Statistical Analysis,Imaging etc would be centralised and provided from the regional centers.Since Case Report Forms,Informed Consent Forms,Training material etc must be made available in the local languages as well ,Helix provides this service through its strategic partners in over 80 languages.
Helix Research Center is always open to working with Global Medical and Research Professional Bodies ,Hospitals,Academia,Ethics and Scientific Committees, Government Agencies promoting Research and Healthcare etc in any part of the Globe.Helix believes in healthy competition and committed to promoting Ethical Research,avoids Conflict of Interest and embraces principles of Symbiosis and Public Private Partnerships as in the Scientific arena 'what is being done is most important than who is doing it'.