Rescue projects and rush timelines are a fact of life in clinical trials. Yet, compressed timelines present risks of data loss or errors. YPrime recently managed a rescue situation involving an IRT system for a Phase II study within an emergency room setting. The project included development of a robust solution to support randomization and clinical supply management. Some of the key challenges at stake:
- Bulk drug supplies were involved, which presented additional inventory control challenges. The study required an efficient method of randomizing subjects without immediately dispensing IP and risking the chance of inadequate clinical supplies for future subjects.
- Surgery was a key component of the study procedure and in turn, timeliness was critical to patient safety. This sick patient population were at risk of serious infection in the event of randomization delays. The entire process – from randomization to dosing – had to completed within 6 hours.
- Alternative communication mechanisms were needed to prevent delays. A typical IRT set-up relies on consistent staffing and scheduling for site-based user roles. Within this ER setting, potential subjects could be presented at any time, 24/7. Rotating staff teams tasked with drug dispensation did not have access to the study’s IRT system.
YPrime worked hand in glove with the sponsor to build a configurable and flexible system that streamlined bulk drug dispensing and supported the specialized randomization scheme.
- For study drug dispensation, YPrime set up a dual fax-based and email alerting system that notified study teams when randomization was taking place. This randomization alert triggered the IRT to subtract the study drug from each site’s inventory.
- Another notification to study teams confirmed primary inclusion criteria, identified during surgery, which triggered drug dispensation or return-to-site stock.
- These two transactions prevented a scenario in which subject randomization took place without adequate clinical supplies and helped ensure patient safety.
- The alerting system allowed study teams to prepare drug in a timely manner without logging into the IRT system.
In the end, YPrime was able to upload all the previously-collected IRT information in our own system with no downtime. At YPrime, our approach to an IRT build offers speed without shortcuts.