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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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