VIVEK SHANKAR KRISHNAN

Development of medical review requirements, including the design of EDC visualizations, and lab visualizations as per the protocol requirement.

Creates a medical data review plan specific to the clinical trial studies, with the protocol of the study.

Performs medical review holistically. The issues identified are followed up with the respective stakeholders until resolution. Works as a Subject Matter Expert based on experience and qualifications.

Provide training on the study and process to new team members.

Worked in studies in various therapeutic areas, like oncology- solid tumors, bladder cancer, and AML.

Cardiovascular - HOCM, Hematology: Hemophilia.

• Medical review of serious and non-serious ICSR from post-marketing cases, which includes spontaneous, literature, solicited, and investigator-initiated studies.
• Based on the experience as a coding expert, subject matter expert, and author of SOP.
• Audit and inspection from regulatory authorities' readiness.
• Therapeutic Areas include Endocrinology, Diabetes Mellitus. Growth hormone, Obesity, Hematology- Hemophilia

• Risk-Based Monitoring Model: Medical Data Review of Clinical Trial Studies in Phase II, III, and IV.
• Review findings are followed up with various stakeholders until resolution.
• Providing inputs on EDC design and visualizations for the study. Forming the medical data review plan.
• Therapeutic areas include Cardiovascular - Hyperlipidemia, Oncology - Breast Carcinoma.

• Worked as a Resident Medical Officer, performing medical rounds with the consultants in oncology, nephrology, and general medicine departments.
• Attending to the emergencies in inpatient wards.
• Attending OPDS in nephrology and serving as a duty doctor in the dialysis unit.