Clinical Data Management (CDM) in Modern Trials: EDC, Validation & Data Integrity
An overview of regulatory Clinical Data Management workflows: Electronic Data Capture (EDC), query management, Medidata Rave / Oracle Clinical integrations, and CDISC compliance.
Founder & CEO, ShrinikaX Technologies
Clinical Data Management (CDM) forms the backbone of pharmaceutical research and biotechnology product approvals. Ensuring that clinical trial data is complete, error-free, verifiable, and compliant with Good Clinical Practice (GCP) and FDA 21 CFR Part 11 guidelines requires disciplined technical and operational execution.
1. Core Pillars of Clinical Data Operations
From Case Report Form (CRF) design to database lock, ShrinikaX Technologies provides end-to-end data cleaning, discrepancy management, medical coding (MedDRA / WHO-DD), and electronic data capture (EDC) support across platforms like Medidata Rave and Oracle Clinical.
Written by Ram Gawas
Founder & CEO, ShrinikaX Technologies
Full-stack engineer and blockchain architect specializing in enterprise AI solutions, Hyperledger Besu, smart contracts, fintech settlement systems, and clinical data engineering.
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