From Risk to Efficiency: Overcoming RTSM System Challenges in Clinical Trials

In the complex landscape of clinical trial management, RTSM system challenges can often derail operational success. While Randomization and Trial Supply Management (RTSM) systems are the backbone of a study, the traditional approach to these tools has long been a source of significant friction.

Reflecting on the challenges faced on the sponsor side, it becomes clear that the "old way" of managing trials—defined by rigid architectures and high-risk manual processes—is no longer sustainable.

Major RTSM System Challenges: Custom Coding

One of the primary RTSM system challenges is the heavy reliance on custom coding. In the past, every unique trial requirement necessitated bespoke code. While this offered a level of tailoring, it created a fragile ecosystem. When a system is built on layers of custom scripts, even a minor mid-study change can trigger a domino effect of technical issues.

The Cost of Rigorous Testing

Because of this custom-heavy environment, the industry moved toward an era of "very specific testing." For every single change made to a live trial, the validation requirements are immense. As a sponsor, understanding the background of these systems means understanding the inherent risks:

• Time Delays: Extensive UAT (User Acceptance Testing) cycles can stall a trial for weeks.
• High Costs: Constant developer intervention and re-validation drive up the total cost of ownership.
• Operational Risk: The fear that a small update might break a critical randomization function often prevents necessary trial optimizations.

Why We Need a Better Way

Knowing the risks, time, and costs associated with traditional RTSM, it is evident that the industry needs to move toward more agile, configuration-based systems. The goal is to shift away from manual coding and toward flexible platforms that allow for rapid changes without the traditional overhead.

How to Modernize Your RTSM Strategy

To mitigate these challenges, sponsors should look for Atreo's modern solutions that prioritize:

• Configuration over Customization: Reducing the need for hard-coding.
• Automated Validation: Speeding up the testing process while maintaining compliance.
• Real-Time Agility: The ability to make mid-study changes without restarting the validation clock.

The complexities of clinical trials aren't going away, but the way we manage them must evolve. By addressing these RTSM system challenges head-on, we can reduce risk and focus on what truly matters: getting life-saving treatments to patients faster.