The USDM Team was engaged for 3 years to provide a managed service solution to support Clinical Data Management (CDM) for EDC/IRT/EPRO UAT.
USDM assigned a team of client approved and trained consultants with client provided laptops that were available to support testing.
Monthly planning meeting allocated resources and planned for upcoming new studies and changes. Emergency changes were also accommodated.
Offsite documentation and onsite test execution.
Metrics were monitored and reported to leadership.
- The scope of the work included: User Acceptance Testing, Change Control and Validation of Standards Library. This included:
- Harmonization/Standardization Phase to validate core IRT system and create a validated EDC library of standardized case report forms and edit checks to be used across multiple studies.
- Ongoing study start-up and changes support for EDC, ePRO and IRT.