End-to-End Clinical Trial Data Management for a New Diabetes Drug (GlucoHealX)

End-to-End Clinical Trial Data Management for a New Diabetes Drug (GlucoHealX) 1. Problem Definition (Storytelling Approach) Background & Business Case PharmaGenix, a leading global pharmaceutical company, is conducting a Phase III, multicenter, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of GlucoHealX , a novel drug for Type 2 Diabetes Mellitus (T2DM) . The study involves 3,000 patients across 15 countries , with a study duration of 18 months . Challenges in the Clinical Trial Data Management Process: High volume of data from multiple sites Missing values, protocol deviations, and duplicate entries in the dataset Data standardization to comply with CDISC SDTM & ADaM models Adverse event tracking and serious adverse event (SAE) reporting Regulatory submission (FDA, EMA) compliance Integration of SAS-based automation to ensure data integrity 2. Scope of Work The project covers the entire lifecycle of clinical data manage...