May 22, 2011
-- Since Human Life is most precious and under no circumstances any kind of harm to Human Body and /or Mind are forgiven either on Moral or Legal grounds, any Healthcare or Clinical Research Services Provider must always strive hard to ensure Utmost Quality Services,Protection of Human Rights,Confidentiality of Medical Information ,Safety and well being of the Patients/Clinical Trial Subjects.More over,as Healthcare is included under 'Essential Services Act' in any country,even inadvertent breach to the same invariably results huge loss in terms of Credibility and Money to any Stakeholder;
Government,Private or Voluntary, of Healthcare and Medical Research Services.It is obvious, any Enterprise ,would expect substantial returns for the Investment made to create State of the Art Infrastructure to endure and survive the competition in the Global Healthcare/Research arena and hence there is a dire need to create and sustain a strong effective System that assures Inernational Standard Services to the Patients,Clients etc.Inorder to assist the various Hospital Managements and Clinical Research Industry, to achieve their goals to offer superlative Quality Services and /or enhance their existing capabilities,Helix Research Center has taken an initiative to offer Clinical and Research Auditing Services for the Stakeholders of Healthcare and Biopharmaceutical,Medical Device and Cosmetic R&D Industry Worldwide.
As any healthcare provider across the globe is aware,Clinical Audit- a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change ( Principles for Best Practices in Clinical Audit-2002,NICE/
CHI), was introduced by Lady With a Lamp;Florence Nightingale in the year 1855 during the Crimea War to improve the Healthcare facilities for injured Soldiers at Scutari Medical Barracks.Introduction of 'End of Plan Idea' by the great American Physician Ernest Codman in the year 1912 and Publication of his own Hospital results ; 'A Study in Hospital Efficiency' in the year 1916 ,must have prompted American College of Surgeons in the year 1918 to introduce 'Hospital Standardisation Program ' that had provided Accreditation Criteria and Standards ,which were later adopted by Joint Commission on Accreditation of Hospitals.Likewise,many countries across the World have contributed their share to define the Quality Standards in Healthcare Delivery.The persistent,consistent and relentless efforts of World Health Organisation to promote Quality Healthcare and the WHO definition 'Health is a state of complete physical,mental and social well being and not merely the absence of disease or infirmity' is familiar to the World Community and Healthcare Providers.
Research-' a structured activity which is intended to provide new knowledge,which is generalisable
( that is of value to others in a similar situation) and intended for wider dissemination'-
Department of Health,UK ,2002),Scientific or Therapeutic is had been one of the most 'Controversial' Scientific activity but most essential part of New Drug Discovery Process.The Stakeholders of Clinical Research;the Clinical/Non Clnical Trial Sponsors,Clinical Research Investigators and their Support staff,Contract Research Organisations,Site Management Organisations/
Trial Management Organisations,Ethics Committees etc must always strive hard to ensure strict adherence to Good Clinical Practices and Comply with Regulations Governing Medical Reseach and produce Quality Data .Since every R&D endeavour potentially can end up as a futile exercise and huge expenditure is incurred by the Sponsors to promote Research Development activities,there is no excuse for any Error or Misconduct during a Clinical Trial.Inspite of all the precautions being taken at every level of Clinical Trial Process,most of the Regulatory Inspections at the Investigative Sites of any Therapeutic area fail to achieve ' No Action Needed' remark by Inspectors.
The Clinical and Research Auditors of Helix Research Center Ltd are Senior Clinicians and Clinical Research Professionals with vast experience in their area of expertise.Most of the Research Auditors had worked for the Regulatory Authorities in the USA,Canada,EU,Oceania,Asia and Africa and Latin America.The Auditing Services are available for prospective Clients in any geographical region and Audit Reports can be provided in over 80 Languages.Apart from conducting Quality Audits,Helix Provides Consulting Services to expedite the Corrective Actions including Training the Hospital Staff or Clinical Research Teams.Helix also provides Promotional Services for Hospitals,( Medical Tourism)Pharma,Biotech,Device,Cosmetic companies and assists enthusiastic Groups,Organisations,Entrepreneurs to establish Healthcare of Medical Research Services Units.
Helix is always keen to work with like minded groups,Commercial,Academic or Voluntary/Philanthropic Organisations to promote Research and Development and Preventive/Curative Healthcare and Conduct Continuing Research and Medical Education Programs,Seminars and Conferences Pan World.
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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