Founders of Helix Research Center have vast experience in entire spectrum of Clinical Research services.We do not believe in Competition and Conflict of Interest and we are always open exploring working relation with like minded companies/Individuals.We offer Contract Research,Site Management,Auditing,Consulting,Medical writing,Training ,Publication,Translation,Pharmacovigilance,Biostatistics,Regulatory Affairs,Quality Assurance,Patient Recruitment,Site Support services in North America,South America,Europe,Africa,Asia,Oceania.We also facilitate Product development endeavours as well.
Clinical Research has been a stable and lucrative Industry for more than 100 years.But there are many issues which hamper new drug development,such as Compliance issues,Informed Consent,Adverse Drug Reactions,Safety and well being of Human subjects participating in Clinical Trials,Human Right Issues so and so forth.Every individual working in Clinical Research arena should be well versed with International Conference on Harmonisation and Good Clinical Practices and Regulations of respective coutries.We strive hard to strictly adhere to ICH GCP and give utmost emphasis for Continuing Education.Nurturing the talent of new aspirants and helping the working professionals to upgrade their skills and knowledge has been our consistent endeavour.
We have an expertise to conduct Scientific as well as Therapeutic Research Worldwide.
We are aware that the Pharma,Biotech,Medical Device,Cosmetic companies incur huge expenditure for their R&D iniaitives and hence we strive hard to add value to their efforts from commencment of a Clinical study till the drug is manufactured and distributed.We understand the concerns of the subjects taking part in a Clinical Trial anbd also the strain on the part of the Sponsor.Hence we try our best for smooth Initiation,conduct and closeout of the study.
Our Regulatory ,Quality Assurance,Biostatistics,Clinical Data Management,Pharamacovigilance ,Medical writing,Auditing and Training team members have vast experience in the International arena and they adhere to strict Timelines to expeidte their assignments.We offer Translation services in over 80 languages and hence translating the Informed Consentg forms various Vernacular languages is done with ease.
We have a strong team of Clinical Research Investigators,Coordinators,Research Nurses and other support staff at the Investigative sites Worldwide.We follow very stringent Criteria to select an Investigator and /or an Investigative Site.Well qualified and Trained Investigaros and supporting staff,Ethics Committees with a flexibility for Expeidted Review if needed,Hospital which has good turn over of patients,nearer to Air Port,Rail way station or a Bus stand,with Cetral lab,IVRS facility,Internet connection,Adequate number of Fax machines,Record room,Video Conference facility,24 hour Emergency Care,Courier service to ship the samples on time,good sample storage facility etc are some of the criteria we follow to select and Investigative Site to place a Clinical Trial.
We follow similar criteria for Pre-clinical,Bio Availability and Bio Equivalence studies too.
We are aware Regulatory Authorities would opt to audit a Site where a Clinical study is being carried out,hence we always scrutinise the documentation team so as to avoid any findings during Audits.
We are highly committed the save the lives of the subjects participating in a Clinical study,hence we ensure that timely treatment /resuscitation is carried out in case of any Adverse events whilst reporting the same to Ethics Committee,Sponsor and Regulatory Authorities as per the ICH Guidelines.
We offer free Career advice to those aspiring to become Clinical Research Professionals and we offer relevant Training Programs at a nominal price.Following is the list of Training Programs we offer globally.
1.Clinical Research Associate
2.Clinical Research Coordinator
3.Clinical Research Investigator
4.Clinical Data Management
9.SAS and Oracle Clinical
10.Trainer' s Training
We also offer Training Programs in Sleep Medicine and Management programs ,especially for sales teams.
We impart Training using most modern modes of delivery such as Online,Online Live,Video Conferencing etc ,aprt from Inclass Training.
All our Trainees are given standard text books written by International Authors .We also conduct Certification exams for working Professionals.
We adivse all our Trainees to become Members of International Clinical Research bodies such as ACRP,SOCRA,RAPS,SCDM etc and provide support for Certification exams being conducted by these global bodies.
We are living in an 'Era 'of Public-Private partnerships,hence we are open to exploring a working relation with any indivifual ,company or an Institution from any country.Let us work towards a disease free world.Prevention is better than Cure!