Data Management

Clinical Data Management for Medical Devices

The quality of a medical device clinical study is ultimately dependent on the integrity of the data collected during the clinical trial. Appropriate, well-organized data are critical to the success of your clinical study. Using documented, repeatable processes, Aptiv Solutions will provide your data faster, without compromising quality. All data collected throughout your clinical trial are handled by our in-house data entry staff. Your data are stored securely and processed in compliance with 21 CFR Part 11 requirements. Our clinical data management services feature:

  • Case report form (CRF) design, development and review
  • Standard or customized database design and development
  • Independent double-data entry, query management and data quality audits
  • Automatic edit checks to ensure data integrity
  • Routine administrative reporting throughout the study
  • Delivery of clean data files and comprehensive documentation
  • Traditional paper-based and Electronic Data Capture (EDC) capabilities available

Contact us today to learn more about clinical trial data management and clinical trial report preparation.

For more information on the difference between paper-based and EDC device trials, read our related blog post.