Direct-to-patient (DtP) clinical trials have made it easier for patients to participate in clinical trials. Patient randomization and clinical trial supply management in DtP trials can be complex. Technology solutions require a great deal of flexibility to ensure that at the end of the lifecycle there is a clear history of when materials are moved from one status to another—allocated to the patient, returned to site (or pharmacy or depot), ready for reconciliation, reconciled.
YPrime DtP Models
Decipher, Standardize and Transform Your Processes
YPrime DtP Capabilities
YPrime’s status-driven IRT solution provides superior flexibility in a configurable model that meets the unique needs of these types of trials.
- Support multiple direct-to-patient shipping models within a single study.
- Dispense one time for multiple visits
- Ship to home health care
- Support hybrid remote and onsite visit schedules for individual patients.
- Trigger shipments, either manually by sites or automatically, with the flexibility to do both within a study.
- Treatment Return module allows treatment to be returned by the patient, or marked lost, to allow for electronic drug accountability.
- Clinical research associate (CRA) can monitor and verify returns remotely or Discrepancy Management feature allows verification without a CRA
- Standard Site IP return-to-depot module allow any kit previously reconciled to be returned to the depot.
- Reconciliation reporting feature makes it easy to monitor compliance on a site level—automates a time-intensive process, eliminates the potential for manual data entry error.
- Lifecycle accountability functionality always allows you to be inspection ready.
- Experts at data transfer and integration.