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IRT in Clinical Trials: Why It Still Frustrates Sponsors—and How to Fix It

Jon Paras, YPrime

A YPrime Blog By:

Jon Paras,
Senior Vice President,
IRT Strategy,
YPrime

Despite decades of evolution, Interactive Response Technology (IRT) or Randomization and Trial Supply Management (RTSM) remains one of the most underestimated yet mission-critical components of clinical trial execution. It governs randomization, drug dispensation, inventory management, and protocol compliance across global study networks. Yet for many clinical trial sponsors and CROs, IRT is still a source of delays, complexity, and missed expectations.

If your team has ever struggled with a mid-study IRT or RTSM change that took weeks to implement, or if you’ve waited days for support to resolve a time-sensitive site issue, it can be an indicator of an IRT system inefficiency. Here’s how the right IRT platform can turn these roadblocks into faster, smoother trial execution.

Through dozens of conversations with industry leaders, IRT experts, and data-backed assessments, three issues consistently emerge:

1. Implementing Mid-Study Changes

Today’s clinical trials demand adaptability, but too many IRT systems remain locked in outdated models—over-reliant on custom coding and manual revalidation for even the simplest protocol amendments. This rigidity slows the ability to add cohorts, revise visit schedules, or adjust dose logic, creating avoidable bottlenecks and missed milestones. Forward-thinking sponsors are prioritizing platforms with built-in self-service capabilities that allow these smaller, amendment-driven changes to be made quickly and securely.

2. Seamless Integrations with Other Clinical Systems

In a fast-paced trial environment, integration is essential. IRT platforms should connect seamlessly with critical clinical systems, supply chain, EDC, CTMS, eConsent, and eCOA to enable a continuous flow of operational and patient data. Without strong integration capabilities, teams can be left with siloed information, manual reconciliations, and blind spots that often emerge only during audit preparation—or worse, in the middle of an inspection. Sponsors should choose IRT solutions that eliminate these gaps, creating a single, trusted source of truth across the study lifecycle.

3. Quick and Efficient Issue Resolutions

Site issues during patient visits demand immediate, expert intervention. When help desk support falls short—whether through slow ticket resolution, limited global coverage, or insufficient knowledge of study protocols—the impact extends far beyond inconvenience. It can compromise patient care, stall data collection, and erode site confidence. In a high-stakes trial environment, support must be proactive, globally accessible, and protocol-fluent to protect both timelines and trial integrity.

When evaluating IRT providers, look for platforms that eliminate common operational barriers through thoughtful design. The ideal IRT solution should empower sponsors and CROs to implement faster protocol changes with less custom coding or extensive revalidation processes. Key features to prioritize include:

bullet iconComprehensive audit trail functionality with point-in-time snapshots
bullet iconResponsive global support that goes beyond basic troubleshooting to provide strategic guidance
bullet iconVisibility into key data based on assigned roles

The right IRT or RTSM partner helps teams consistently deliver on timelines, maintain data integrity throughout the study lifecycle, and remain inspection-ready at every phase of the trial.

When evaluating IRT solutions, consider more than just whether it can randomize patients and ship kits. Ask the following questions:

bullet iconHow quickly can the vendor partner implement specific system changes based on protocol amendments?
bullet iconIs the IRT built for integration with your broader eClinical ecosystem?
bullet iconAre audit trails accessible, transparent, and regulator-ready?
bullet iconCan it scale to support complex and adaptive trial designs?
bullet iconHow does the support team respond when the pressure is on?

To help assess whether your current or prospective IRT solution is truly built for today’s clinical trial demands, download YPrime’s IRT Checklist. It outlines the key capabilities and questions every sponsor and CRO should consider before their next study.

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