Dr.Nameeta Sonar

Present Duties and achievements as Medical Monitor/Clinical Project Manager include:

• Developed and executed Clinical Trial plans and protocols for Phase 1 and Phase 3 human clinical trials of Biosimilar Insulin Analogs - provided medical expertise required for execution of clinical studies by clinical research organization and sponsor (BioGenomics Ltd)
• Contributed through own knowledge of scientific concepts related to design of protocols and analysis of clinical trials for diabetology products including inclusion-exclusion criteria, screening, treatment algorithms, bioanalytics and immunogencity (clinical safety) analysis.
• Co-ordinated between clinical research organization (CRO), BioGenomics as sponsor and various clinical sites with respect to clinical trial oversight and patient safety in clinical trials.
• Designed inclusion and exclusion criteria towards meaningful Phase 1 and Phase 3 objectives
• Prepared trial related documents and reports for regulatory submission (ICH GCP guideline compliance )
• Closely coordinated with with Clinical Trial Site Team, Logistics and Clinical Research Organization from sponsor's perspective.
• Conducted Monitoring Visits for ensuring GCP compliance and patient safety, data integrity at various sites.
• Regulatory Skills - Directed and overseen short-term and long-term regulatory submissions.
• Prepared and executed strategies for approval of regulatory submission.
• Prepared responses to inquires from regulatory authorities.
• Submitted supplements and amendments to update registered product information.
• Handled budget requirements and monitor project and program costs.
• Conducted Reviews, evaluations, and compilation plus documentation of files and reports for submission.
• Prepared outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments and outside agencies - Coordinated with cross-functional departments within and outside of organization for regulatory submissions.

• Founded subscription based healthcare service in local community.
• Performed duties as chief medical officer and general practitioner.
• Provided Primary Healthcare Services predominantly in acute illnesses.
• Designed and wrote several articles in media for product positioning and brand building.
• Managed over 50 patients per day during corporate and school health check ups.
• Referred patients to medical specialists for consultant services when necessary for patient's well-being
• Maintained high patient satisfaction through knowledgeable support and compassionate care.

• Designed algorithms for various diagnostic test panels for differential diagnosis using biochemistry, immunodiagnostics and molecular diagnostics for national level, centralized organization.
• Designed over100 clinical diagnostic test report formats for easy interpretation of results for patients.
• Offered medical and strategic input to advisory boards to foster engagement with clinical advisors.

Post graduation medical internship completed involving :

• In diagnosing common diseases, use of essential drugs and laboratory services.
• Duties of primary health care practitioner in rural areas for 2 months.
• All type of emergencies-medical, surgical, obstetric, neonatal and pediatric.
• Monitoring of National Health Programme and schemes, oriented to provide preventive and promotive health care services to community.