Data Management

What is Clinical Data Management?

Clinical Data Management (CDM) covers the process of collecting, validating, and preparing the data towards statistical analysis for clinical trials. This starts with setting up a clinical data collection tool(s) or a clinical database based on study protocol to collect and store data. Once data is stored, implementing data validation steps is crucial to ensure accurate data is collected and complies with ICH-GCP and all applicable global and local regulatory requirements. Once the data collected is fit for analysis, the database is locked to avoid any modification and datasets are delivered to statistics and programming teams for analysis.

Clinical Data Management Services

Our experienced team of Data Managers are on-hand to advise and support all aspects of data capture and analysis from CRF design through to database lock. We have extensive experience in all phases of trials and work closely with both the clinical and reporting teams to ensure efficient collection and delivery of the highest quality data.

Creation of data management plan

CDISC compliant documentation

Medical coding setup and implementation

Electronic data integration

Data query generation and maintenance

SAS listing development

External data import and reconciliation

Clean patient tracker, missing pages reports

Database locks & post lock archival