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, MDCI will provide your data faster, without compromising quality. All your data collected throughout your clinical trial are handled by MDCI's in-house data entry staff. Your data are stored securely and processed in compliance with 21 CFR Part 11 requirements. MDCI operations are ISO 9001:2000 certified. Our 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
For more information on the difference between paper-based and EDC device trials, read our recent blog post.
Contact Us
Reach our Massachusetts office at 1-508-643-0434, Monday through Friday, 9:00 a.m. to 5:00 p.m. Eastern. Or fill out our contact form and a consultant will contact you directly.
Device Regulatory Guidance
Click here to view FDA and International Regulatory Guidance for medical devices.
Client Testimonial
The expertise and knowledge that MDCI shared truly helps us accomplish our mission of helping U.S. companies increase their export sales.
- International Trade Specialist at US Department of Commerce