Clinical Data Management

Clinical Data Managers (CDM) are critical members of your clinical trial team, working hand-in-hand with project management, study monitoring, and biostatistics to ensure that the data generated from your study are accurate and complete and that your results are reliable and meaningful. CDM support research throughout the project lifecycle, from protocol development through statistical analysis and submission of results to regulatory authorities. CDM are trained in Good Clinical Data Management Practices and CDISC Standards.

• Design of data collection instruments and surveys
• Build and maintenance of electronic data capture systems
• Patient-facing data collection including electronic surveys, ePRO, and eConsent
• Study-specific data collection training
• Creation of Data Management Plans, CRF Completion Guidelines, and other CDM documents
• R/SAS/SQL programming for data quality and operational reporting
• Ongoing central data review and query management, to ensure your data is accurate and complete for interim analysis and routine reporting to FDA, DSMB/DSMC, and NIH
• Reconciliation of serious adverse events and external service provider data
• Medical coding and coding review
• Final data review during study close out
• Database validation, lock, and release to the statistical team for interim or final analysis
• Data uploads to NDA and other data repositories
• Clinical data archiving

Our team is available to meet with Investigators to discuss support services that fit your project needs. Requests for consultation and service proposals can be submitted on the service request form link.