- Apr. 1, 2012 -
Having analysed and understood the Non Clinical & Clinical Trial outsourcing trends in the Global Clinical Research arena and the challenges being endured by the stakeholders of Research & Development Industry;Viz the Pharmaceutical,Medical Device,Biotechnology and Cosmetic Industry Worldwide , the issues such as Financial constraints,safety and well being of Trial subjects,Errors,Misconducts,negative talk about the Clinical Trial activity itself in one or the other media and the need for introducing many new Medicines and Devices to alleviate the suffering of the Global Community from most dreadful diseases causing exponential increase in mortality and morbidity etc,Helix Research Center has taken an initiative to Introduce and Promote the concept of 'Clinical Research Practices ' both in the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) and Non ICH regions of the World.
It is imperative implementation of Clinical Research Practices concept is not as easy as 'Clinical Practices' that are very popular and successful in North America,Europe and World in general, for the simple reason Medical Research is much more complex activity than Clinical Practice.Since the Guidelines and Regulations Governing Biomedical Research are not completely Harmonised throughout the World,the Clinical Trial Sponsors may be skeptical about the concept being emphasised and recommended.But even the senior Members/ Inspectors of various Regulatory Authorities,Members of Ethics Committes ( IRBs/IECs)/Scientific Committees,Senior Clinical Research Professionals,Journalists involved in writing articles related to Life Sciences etc would agree when an acceptable definition of a CRO ( Contract Research Organisation ) is ' an individual or a company;commercial ,academic or other,hired the Sponsor to expedite one or more Clinical Trial related tasks' ,allowing 'Clinical Research Practices' to take up Pre Clinical,BA/
BE ( Bio availability/
,Phase 0 through IV Studies is definitely a viable and rationale option indeed.After all,any idea or concept that assures Safety and well being of Trial subjects ,generation of quality data,completion of studies within the Timelines,No action required note during Audits and huge savings in Trial budget is always well accepted.
Helix Research Center maintains a huge database of experienced Clinical Research Professionals;
Clinical Research Investigators/
Principal Investigators and their support staff,Project Managers,Research Nurses,Clinical Research Associates,Clinical Research Coordinators,Pharmacists,Biostatisticians,Quality Assurance/Regulatory Affairs/Pharmacovigilance personnel etc from Asia,Africa,Europe,Oceania,South America and North America ,and some of these Professionals offer their expertise as Free Lancers/Consultants.Facilities to conduct Pre Clinical,BA/
BE,Phase 0 through IV studies have already been identified,which are available on Project by Project basis.The Standard Operating Procedures ( SOPs) are customised the for the facility and the Professionals in the database perform their duties with the designations mentioned in the SOPs with strict adherence to Confidentiality and Good Clinical,Laboratory practices ( as applicable). The study grant is distributed amongst the members of the 'Practice' as per the agreed terms and conditions.
Helix Research Center believes, in the scientific arena' what is being done is most important than who is doing it' and hence does not claim that the 'Clinical Research Practices' concept being promoted is first of its kind in the World.It is obvious such models may be already available in the regions where the Clinical Research is actively promoted.The Management of Helix is always keen to working with like minded Entrepreneurs,groups ,Professional associations ,Govt agencies in any part of the World to promote Continuing Education programs in Healthcare/Research,preventive and Curative Healthcare .
# # #
Helix Research Center Ltd is a London(UK) based global company offering Contract Research,Training,Auditing,Consulting,Medical Writing,Pharmacovigilance,Biostatistics,SMO,Regulatory Affairs,Quality Assurance,Publications,Translation ,CDM services globally