Promoting Alliance of Hospitals Concept to Expedite Global Clinical Trials

Online, December 23, 2010 (Newswire.com) - Strained by the Soaring expenditure to bring a new Drug to the market and embarrassing incidents at the Clinical Trial Sites such as Patient/Subject dropouts,invariably inadvertent Protocol deviations,Errors,Misconducts,Adverse Events etc,the Stakeholders of R&D Industry,Viz -Pharmaceutical,Medical Device,Biotechnology and Cosmetic companies,National Institutes of Health (NIH),World Health Organisation (WHO),GAVI Alliance etc are always looking for Hospitals well known for Strict GCP Adherence,with state of the art Infrastructure and qualified Clinicians in terms of Education,Training and Experience.

It is a common practice for the Regulatory Affairs and Compliance unit of a Sponsor Company/Organisation to contact a CRO ( Contract Research Organisation) with an RFP ( Request For Proposal)to find out whether or not the particular CRO has the Expertise to take up the Study.It is also a regular practice to hire the Services of an SMO/TMO (Site Management Organisation/Trial Management Organisation),if the study has to be conducted in many countries and many centers.SMOs and TMOs usually have common SOPs (Standard Operating Procedures) for their Member Hospitals and Clinical Research/Study Coordinators for each Trial Site.Since fulfilling all the pre-requisites inorder to become a stonrg contender to obtain a Clinical Trial contract involves significant Investment by a Site Management or a Trial Management Organisation and hence an indirect extra budget for the Clinical Trial Sponsor,the financially strained Sponsors are at times Skeptical to avail Services from these Enterprises.

Inspired by the Hospital networks created by Japanese Medical Association and those created by various groups of experienced Professionals in the United States,Helix Research Center has been conducting Due Diligence on the possibility of promoting the Concept of 'Alliance of Hospitals' since a past 5 years or so.The Senior Team Members and Consultants of Helix from different parts of the World,Clinical Researchers of International repute etc have strongly opined that Multinational,Multicentric Clinical Trials can be placed at Alliance of Hospitals and Hospital Networks that do not share common SOPs or support Teams.

An Astute Clinician of any Therapeutic area does not need much time to decipher and comply with GCPs( Good Clinical Practices)and the junior doctors,Nurses,Pharmacists,Lab Technicians etc can be Trained well to accomplish their assigned tasks as per ICH GCP and any other Guidelines.One does not require 'Einstein' level Intelligence to get acclimatised to preparing the Dossier to be submitted to Ethics Committees,Record keeping or reporting Adverse Events.

All the Hospitals have their own SOPs and the workforce are familiar with the importance of Confidentiality.The junior Clinicians,Nurses handle most difficult Patients and their accomplices daily,hence taking 'Informed Consent' and documenting the same is not a Herculian task for them.Since it is mandatory to prepare Training manuals for every protocol and conduct Training for the Principal Investigator and his/her support team,there is no room for any Protocol deiviation or Errors.The Hospitals involved in Research activities can follow the 'Code Blue'System so that all possible mistakes can be avoided.

Helix is already working with many Healthcare providers in many countries and will be working hard to facilitate creation of more Hospital networks.Since 'Eyes can not see if the Mind does not know' Helix has introduced many GCP Training Courses for the Corporates as well as aspiring Life Sciences Job Seekers.The Founders of Helix Research center are always keen to Collaborate and Cooperate with like minded Entrepreneurs,Groups,Organisations in any part of the World, inroder to promote Drug Discovery and Healthcare.