Clinical trial Execution: Phase I,II,III, IV studies
- Site Selections & site feasibilities.
- Investigator selection and finalization.
- Development of Protocol, ICD,CRF and Investigator brochure as per Guidelines.
- Coordinating with Language translation vendors for CT Documents translations as required.
- Submission of documents to CDSCO for CTNOC as per regulations.
- Preparations of Ethics Committee Dossiers according to site requirements.
- Initiations of Ethics Committee submission for review & approval.
- Coding and dispensing of investigational product samples to investigators/Sites.
- Dispensing of site materials.
- Preparation of Site master files and maintaining of updated documents in SMF.
- Co-ordination with the investigators for patient Enrollment.
- Conducting Interim Monitoring visits for data collection and retrieval.
