Trial Design

Who better to design your DATATRAK ONE® Unified Experience™ study than our own Trial Design team? Our team has extensive experience in multiple therapeutic areas and trial designs across Phases.

eCRF Design
Our Trial Designers will lead you through our established eCRF design process.

  • EDC system configuration
  • eCRF Shell Specifications
  • eCRF Shell Design & Testing
  • Validation Check Specifications
  • Validation Check Design & Testing
  • External Data Import (if applicable) – Develop & Test
  • Final system testing

Depending on study complexity, we can develop custom scripts as needed, and use our experience to guide you around common design pitfalls.

Randomization and Inventory
If you elect to include Randomization and/or Inventory services, the Trial Design team will be work with you on all required setup and testing steps.

Custom Exports
If you need your study data exports from the DATATRAK ONE® Unified Experience™ solutions mapped to a specific structure, we can handle that too. Custom exports are part of the trial design and can be configured to your specifications.

Mid-Study Changes
Although they aren’t planned, protocol changes happen in even the best thought out clinical trials. When that happens, your study may require updates – our Trial Design team will work with you to implement those changes quickly and efficiently.