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Introducing and explaining specific research projects, new tests, drug,
therapeutics to physicians, technicians and research assistants.
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The development of ICMR compliant informed consent collection protocols
and Case Report Forms (CRF).
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ICMR (Indian Council of Medical Research) submissions.
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Cost estimation and negotiation with Institutes / Hospitals.
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Site selection, initiation and monitoring.
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On-site sample management and logistics support.
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Preparation
of protocols, data sheets, dossiers, forms as complaint with DCAI (Drug
Control Authority of India) regulations in India.
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Finalization of time schedules / costs with the sites conducting the
trials.
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Follow up and monitoring at trial sites.
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Follow up with DCAI for registrations and approvals of products.
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Co-ordinating
with National Institute of Biologicals (NOIDA) the centralized site
approved by ICMR and DCAI for conducting trials / evaluations and
submissions of the report to DCAI for registration and approval
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