Helix Launches New Service For The Global R&D Stakeholders

LONDON - Sept. 27, 2015 - PRLog -- It is a well known fact conducting Pre Clinical ,Bioavailability,Bioequivalence ,Phase 0 to IV Studies is one of the most challenging tasks for the Global Pharmaceutical ,Medical device,Cosmetic,Biotechnology,Food & Nutrition R&D Stakeholders.If the studies are not conducted under strict adherence to Guidelines and Regulations governing Biomedical Research ,R&D companies have to face severe Regulatory issues and if the studies are not completed within timelines ,the study budget will soar in the sky.In Today’s World ,global economy is prone for strain and budget control is one of the most important factor to sustain Research and Development endeavours .With over 15 years of Contract Research experience in ICH and Non ICH regions,being familiar with issues pertaining to Pre Clinical and Clinical Research ,the Chairman of Helix Research Center Ltd has taken a decision to launch a new service for the Global Clinical Trial Sponsors to expedite the studies within timelines and to reduce the study budget.

The usual Contact Research Project outsourcing is , Clinical Plan Development team,usually Regulatory Affairs and Compliance unit of an R&D company ,contacts potential CROs or SMOs and shares an outline of the Study.After having the biway CDA/NDA in place and the CROs,SMOs prepare the budget for the Study and share the tentative timelines for the Regulatory,IRB/IEC approvals ,Study initiation ,completion etc .Sponsor company conducts Audit of the facilities to short list /finalise the CRO/SMO.If the Sponsor plans to conduct Multinational Mulcentric Studies ,finalising the CRO/SMO partner is a herculian task and time consuming and obviously involves huge expenditure .

After conducting Due Dilience in the global market for over a decade ,Helix has identified Pre Clinical ,BA/BE,Phase 0 to IV CROs and SMOs in over 130 countries and also maintains a database of expeienced Clinical Research Associates ,Project Managers ,Research Nurses ,Clinical Research Coordinators ,Clinical Research Investigators ,Quality Assurance ,Clinical Data Management ,Pharmacovigilance experts ,Biostatisticians ,Medical Writers ,Translators ,Regulatory Consultants ,willing to work on contract basis .Hence ,Helix has launched a Consulting service to be an exclusive Representative for the Global Pre Clinical/Clinical Trial Sponsors to identify and select the suitable CRO,SMO or an Investigative Site to place the studies .

Helix has also developed the capabilty to source Comparators /Reference Products for the Clinical Studies ,Cold Chain Management ,Logistics ,Storage ,Distribution of the Investigational Products,Packaging ,Labeling services ,in association with local strategic partners .Chairman of Helix Research Center Ltd ,Dr Venkatewar Rao G ,said 'we have launched this new service for the Global Pre Clinical ,Clinical Study Sponsors with a Vision to reduce the Study budget by atleast 40%,without compromising with quality and under strict Regualtory Compliance ;we invite R&D Stakeholders from ICH & Non ICH regions to make use our CRO,SMO,Site Identification and Selecion expertise.'