Site Management &Support Services for Global Clinical Trials

Aug. 24, 2011 - PRLog -- In view of the absolute necessity to ensure ,Safety and well being of Clinical Trial Subjects ,strict adherence to Good Clinical Practices Guidelines and Regulations governing Biomedical Research by Doctors of various Therapeutic areas such as Cardiology,Neurology,Oncology,Endocrinology,Pulmonology,Psychiatry,Obstetrics & Gynecology,Gastroenterology,Opthalmology,ENT,Internal Medicine,General Surgery etc,the need to produce quality data for a given study,reduce Regulatory delays,prevent avoidable errors and misconducts during a Clinical Trial,reduce the avoidable overheads for the Clinical Trial Sponsors such as Pharmaceutical,Medical Device,Biotechnology,Cosmetic companies,various UN bodies,Government,Non Profit Organisations,alliances formed by Public-Private Organisations,Philanthropic Groups etc,Helix Research Center has taken an initiative to provide Site Management,Site Support and Consulting Services to facilitate hassle free execution of Global Clinical Trials in any part of the World, Viz: Asia,Africa,Oceania,Europe,South America and North America.

Even though Helix Research Center is associated with huge number of Hospitals in different regions of the World and has been providing Site Management Services directly or indirectly for various Sponsors,CROs and working in association with other SMOs,the efforts to reduce the Timelines in obtaining Ethics committee approvals,enrollment of patients,preparing the Sites for Inspections/Audits by Regulatory authorities etc could not be accomplished to a satisfactory level.Inspite of taking all the necessary precautions to obtain the 'Informed Consent ' as per the ICH Guidelines,issues related to Bioethics keep creating Havoc in the community.It is an established fact that any Medicine or Investigational new Medicine can cause adverse events and all the stakeholders of R&D activities are aware the same.However,the Hospital Managements,Principal Investigators and their support staff must strive hard to contribute their share inorder to prevent the indispensable activity called R&D/New Drug Discovery getting obscured/eclipsed due to day today avoidable problems in Clinical Research arena.

The Site Support services being offered by Helix Research Center include Identification of Hospitals/Practices  which with necessary support,could  emerge as potential Sites to conduct Phase 0 through IV Clinical Trials and even Bio Equivalence & Bio availability studies  involving patients,Writing SOPs ( Standard Operating Procedures),formation of  Ethics Committees ,Auditing  the facility to assess the infrastructure requirements,conducting  GCP Training for the prospective Investigators,Clinical Research Coordinators,Research Nurses,Biostatisticians,Pharmacists,Laboratory and Imaging Departments,Business development teams etc ,promoting the Site directly and indirectly,providing necessary technical support/personnel to expedite initial projects so on and so forth.

Helix Research Center is keen to enter into strategic alliances with any like minded Site Management/Trial Management Organisation,CRO,Alliance of Hospitals (Non SMO) ,if such partnership  is useful to promote Ethical Research and promote healthcare in any part of the globe.It is a well known fact that many Clinical Research Organisations established by most accomplished individuals/groups in some parts of the World were severely affected by recession and the Managements of such enterprises have incurred huge expenditure for creating state of the art Infrastructure.Helix Research Center is keen to provide unconditional Professional support and /or enter into a working partnerships with such Organisations inorder to reduce their  overheads and increase the productivity.Prospective clients,partners or Trainees are welcome to contact the Consulting division of Helix preferably by email.

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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