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HELIX CLINICAL RESEARCH AND DEVELOPMENT CENTER
Helix was established in the year 2005 as an independent academic and regulatory contract research organization in order to develop,
initiate and co-ordinate clinical trials (pre clinical, pharmcodynamics, clinical phase I, II, IIb, III and post marketing and
sub-economic/quality of life and indication extension global studies and local registries) relevant for the development and approval of
pharmaceuticals, biologics, medical devices, APIs and Generics and centralized radiology imaging, molecular imaging, core lab, blood lab,
ECG/EKG, EMG services. Since its inception, Helix has gained extensive experience in the centralized coordination and clinical projects
logistic, site personnel and physicians protocol and ICH-GCP training and in the Site Set-Up and Site Closing-Out processes.
Helix undertakes all aspects of clinical research from protocol, crf/edc, patient information and consent and investigator brochure
development and application submissions to competent authorities and notified bodies in India, Australasia, Germany, whole of Europe and
north and south of America.
Helix focuses on single hand drug and device development. We are proud to say at Helix"scientific, regulatory and commercial
expertise meets service". We offer highly specialized hospitals and clinical research facilities based clinical trials management.
Our partners are highly specialized core laboratories, imaging centers, molecular imaging centralized service providers, data management
to statistical analysis centers, KOL based reporting, presentations and publication (major Asian, European and US congresses and in the
major peer reviewed scientific journals) centers.
Helix is in full conform to DCGI, DGFT, FDA, EC, EMEA, ICH-GCP, cGLP, cGMP, 21 CFR, ISO, HIPAA standards.
Helix promotes the concept of high quality and principles of quality management, full GxP adherence and implements quality improvements.
HELIX SITE START UP and SITE RELATION EXPERT SERVICES
for GLOBAL DRUG, DEVICE and BIOLOGICS DEVELOPERS:
1. Site Selections, Investigator Selections (including PIs) and Feasibility of Identified Sites:
- Helix assists the sponsors and CROs in the identification of potential and ICH-GCP trained Investigators
- Helix conducts high quality feasibility for the potential site Investigators identified
- Helix trains site staff "Fast Study Subjects Recruitment and Adherence to ICH-GCP and 21 CFR Part 11"
- Helix visits potential investigators to ensure the adequacy of site staff with regard to Sponsor SOPs, Study Protocols,
CRFs/EDCs, Patient Information and Consents, ICH-GCP, cGLP, 21CFR Part 11, Ethics Committee/MECs and IRBs, QSP-15A
2. Helix in-house work pertaining to sponsor's project/full service, single service, scope of works start-up:
- Helix prepares site selection trip according to sponsor's SOP and budget
- Helix collects, reviews, tracks and archives the project related documents, study protocols and amendments, CRFs/EDC - templates,
Investigator Brochures, Patient Information and Consents, Ethics Committees-Applications or EC Votes/approvals, clinical drug, clinical
device or import-export license, IP-Justification or T-License
- Helix uses special mentoring strategies to facilitate the collection of documents required for making the application to DCGI
- Helix supports the IP-justification for T-License application process and the calculations and other supporting documents needed
for DGFT application
- Helix works Hand-in-Hand, on daily basis with the Clinical Project Managers and Regulatory Affairs Managers of the sponsors
- Helix organizes, prepares, attends or lead and presents the Sponsor Study/Protocols, CRFs, Patient Information and Consents, Drug
and Device Application, Clinical Drug and Device logistic, handling and positioning, monitoring, FDA/EMEA/DCGI site audits, ICH-GCP,
21 CFR Part 11, cGLP, trial news letters and future clinical data publication
- Helix delivers study related documents and clinical product to selected sites and offers full ICH-GCP training to site staff
- Helix reports study and site status on daily basis to sponsor representative
- Helix provides full clinical trial service support to busy sponsor PMs