✓ Contributed to the development of protocol for Phase II, Phase II/III and Phase III.
✓ Drafted sections like synopsis, study design, study treatments, visit procedures and safety monitoring for therapeutic area of vaccines.
✓ Contributed to literature search for safety profile of marketed drug in dental protocol.
✓ Assisted in writing safety monitoring, study treatment, data management and regulatory & ethical requirements for indication of COVID-19 infection.
✓ Resolutions for all protocol-related medical and safety queries, maintenance of Q and A log
Clinical Study Report
✓ Prepared complete clinical study report in pneumococcal vaccine indication.
✓ Drafted shell of CSR and safety section in non-small cell carcinoma and metastatic colorectal cancer indications.
✓ Review and preparation of Serious Adverse Events and pregnancy narratives
✓ Contributed in drafting manuscript in vaccine study.
✓ Prepared poster as per journal requirement for pneumococcal vaccine study.
• Review of safety section in Informed Consent Form and feasibility reports
• Review of line listings prior to Safety Data Review Meetings and also said frequency as per protocol requirement.
• Protocol training conducted for internal on rotavirus, pneumococcal vaccines protocols.
• Safety reporting training conducted for internal team and clinical sites at investigator meeting, site initiation visits for pneumococcal, rota virus, odontogenic and oncology protocols.
• Preparation and presentation of clinical study update report for DSMB and Safety Review Meeting for vaccine studies.More...