Medical Monitoring

Medical Monitoring

MIC has qualified, experienced, board-certified physicians (Doctor of Medicine) to support medical monitoring activities in clinical studies as below to ensure the safety of the interventions and the validity and integrity of the data. MIC Medical Monitor also helps in the overall end-to-end clinical development of NCE/NBE molecules spanning from designing clinical trial documents, conceptualizing clinical study design, exploring innovative approaches/models for proof-of-concept studies, and most importantly developing clinical development plans and target product profiles.

• MIC medical monitor provides 24 X 7 coverage and backup coverage to the study investigators. Medical monitors answer questions from investigators, study coordinators, regulatory personnel, and other clinical study team members and provide protocol clarifications and interpretation of inclusion/exclusion criteria.
• MIC Medical monitors support review and confirmation of the eligibility of the patients to ensure that the appropriate patients get enrolled in the study.
• MIC medical Monitors ensure review of adverse event (AE)/concomitant medications, Clinically Significant values of labs, and ECG and understand the trend safety trend and risks to the patients.
• MIC medical Monitors assess Serious Adverse Events (SAE), causality, and expectedness and review narrative, determine if individual case safety reports (ICSRs) meet the criteria for expedited reporting and review the Analysis of Similar Events (AOSE), and provide recommendation for Unblinding/Unmasking.
• MIC medical Monitors assess the overall safety of the compounds and Benefits-risk assessment.
• MIC Medical Monitors review, categorize, and/or assess protocol violations/deviations and confirm if the patient is eligible for Per-Protocol analysis.
• MIC Medical Monitors review the coding of adverse events (AEs), Medical history (MH), and Concomitant Medications (CM).
• MIC Medical Monitors supports in responding to queries from Institutional Ethics Committee (IEC)/Independent Review Board (IRBs) and Regulatory Agencies such as DCGI/US FDA.
• MIC Medical Monitors supports Sponsor in presenting the protocol and study background to the Indian regulatory authority DCGI/Subject Expert Committee (SEC) and US FDA and participate in the Pre-IND meeting, End of Phase 2 meeting (EOP2), and various research funding agencies (DBT/BIRAC) at different stages of drug development.