Case Study

 

Configurable IRT: Unprecedented Flexibility and Speed without Shortcuts

In early phase drug development, the need for speed is a given.  The sooner a sponsor can make a go/no go decision, the sooner they can prioritize promising compounds and fast track them for regulatory submission. A configurable IRT system can mean the difference between a speedy path to submission, or one that is plagued with costly development delays. When a first-to-market opportunity is at stake, speed is the difference between success and failure.

Consider a recent YPrime project involving oncology. A Phase I study with an adaptive trial design and open-label enrollment needed a flexible solution for dose management. Configurable features within YPrime’s IRT system provided a level of user-driven functionality and speed not possible before.

The protocol design allowed for study level dosing adjustment among every subject or cohort as needed, with the potential for more than ten dose changes over study duration. YPrime’s IRT+ allowed for the study team to adjust dispensing levels themselves within the system, without change orders or any involvement from external parties.

Using a traditional IRT system, dispensing changes require a major system interruption – in the form of change orders, followed by programming, testing, validation and multiple review cycles, and span anywhere from two to eight weeks whenever a dose is switched. With the potential for any number of protocol amendments requiring a dispensation update, time lost due to change orders is not only staggering but highly impractical.

For this sponsor, YPrime’s configurable IRT allowed them to collect data quickly, and provided the ability to proceed directly to the next phase of development once the optimal dose was determined.

As the use of the adaptive trials in clinical development continues to rise, configurable IRT offers the most efficient path to your next milestone by removing unnecessary delays, cost and complexity. Contact us to learn more.