Joshi Doni

1. Conducted comprehensive reviews of clinical documents for regulatory compliance and GCP adherence.
2. Managed and maintained the eTMF, ensuring timely and accurate document filing.
3. Collaborated with clinical teams to resolve discrepancies and ensure document accuracy.
4. Prepared eTMF for audits by ensuring completeness and addressing deficiencies.
5. Ensured data integrity and confidentiality in compliance with data protection policies.
8. Verified document version control to maintain consistency and prevent redundancy in the eTMF.
9. Identified and mitigated risks related to document management.

10. Supported cross-functional teams by ensuring eTMF readiness for regulatory inspections.

1. Reviewing the documents that describe the study objectives, design, methods, assessment types, collection schedules, and considerations for analyzing the data.

2. Investigator's brochure - compilation of the clinical and nonclinical data on the investigational products.
3. ICF - One of the most important elements of the system ensuring the ethics of medical experiments and protection of the rights of study is ensured with a protocol. A CRF is a paper or electronic document that consists of each participant's trial data, which is reviewed and documented according to the protocol.

Data verification:

Guaranteeing the accuracy, integrity, and validity of clinical, analytical, and statistical data in adherence to FDA regulations for BE studies while promptly recognizing any substantial deviations.

Monitoring clinical trials:

Directed the execution of clinical studies conducted on healthy human volunteers, maintaining strict adherence to international guidelines and national regulatory standards.