•        Preparation and Review of Clinical Report •        Review of Protocol •        Review of CRF data •        Monitoring of Study during conduct of recruitment, dosing, sample collection, sample processing and sample shipment  (around 10 Study monitor and Handled) •        Online review of Volunteer management and volunteer recruitment •        Internal & External audit handled •        Review of Laboratory data for exclusion and inclusion criteria as per recruitment •        Verification of Instrument validation and IQ, OQ & PQ •        Calibration record, AMC, Agreement records, training record, medical record verification and maintenance were done. •        Submission of final report as per eCTD modules