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Clinical Data Management
Clean, Reliable Data — Ready for Analysis.
Clinical Data Management (CDM) is the process of collecting, cleaning, validating, managing, and preparing clinical trial data so that it is accurate, complete, consistent, and suitable for statistical analysis and regulatory submission.
CDM sits at the heart of the clinical research process, following the flow from clinical trial conduct through data collection, data management, data cleaning, database lock, statistical analysis, and finally the Clinical Study Report.
Our data management team combines rigorous process with modern EDC systems to keep every dataset audit-ready and analysis-ready, from first patient enrolled to final database lock.
Our Clinical Data Management Services
From Study Design to Database Lock.
We manage the full data lifecycle, covering everything from data management planning and CRF design through query resolution, medical coding, and final data transfer for analysis.
DMP & CRF/eCRF Design
Defining the Data Management Plan and designing paper or electronic Case Report Forms to capture protocol-required data.
Database Build & Edit Checks
Building and configuring the clinical trial database within an EDC system, with automated edit checks to flag inconsistent or missing data.
Query Management & Medical Coding
Raising, tracking, and resolving data discrepancies, and coding medical terms and medications using MedDRA and WHO Drug dictionaries.
Reconciliation & Database Lock
External data and SAE reconciliation, ongoing data review, and finalizing the cleaned database for statistical analysis.
Data entry and validation are checked against predefined requirements, with edit checks catching inconsistent or missing data early.
Once the database is locked, finalized datasets are transferred to biostatistics and programming teams for analysis.
Frequently Asked Questions
The process of collecting, cleaning, validating, managing, and preparing clinical trial data so that it is accurate, complete, consistent, and suitable for statistical analysis and regulatory submission.
Clinical trial conduct, data collection, data management, data cleaning, database lock, statistical analysis, and Clinical Study Report.
The process of raising, reviewing, tracking, and resolving discrepancies in clinical data to keep the database accurate and complete.
Medical terms and medications are coded using standardized dictionaries such as MedDRA and WHO Drug.
The finalized clinical database is closed once all data and queries are resolved, and datasets are transferred to biostatistics and programming teams for analysis.