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