Clinical Data Management for Medical Device and IVD studies
Accurate data. Aligned with standards. Ready for reporting.
At GBA Key2Compliance, we offer full Clinical Data Management (CDM) services tailored for medical device and IVD studies. We can help you all the way from planning your dataflow, setting up eCRF, collect and clean data to database lock and clean file to have reliable data that supports regulatory compliance and clinical evaluation.
Our CDM services are fully aligned with Good Clinical Practice (GCP), ISO 14155, and ISO 20916 – supporting everything from study setup to Post-Market Clinical Follow-up (PMCF)data outputs.
Data Management support
Need standalone data management or full CRO support?
Contact us to discuss your needs.
- Data Management oversight (CRO oversight or System vendor oversight)
- Data Management documentation review and input
- Data Management mentor
- Data Management audit support
What We Deliver
Study Start up
- Planning data flow involving multiple datasources
- Data Management documentation
- CRF/eCRF/ePRO design, review, build, and training
- Clinical database setup, testing and validation
Study Conduct
- Clinical database update, testing and validation
- Data validation, cleaning, and medical coding
- Query and discrepancy management
- Interim data review and safety support
- Data reconciliation (labs, AE, SAE, etc.)
Study Close-out
- Data reconciliation (labs, AE, SAE, etc.)
- Final database lock and export
- Clean file
- Data Management documentation
- Clinical database decommissioning and archive