Why Over-Customization is Killing Your RTSM System Scalability

In the world of clinical trial technology, "custom" is often sold as a benefit. However, the reality for many providers and sponsors is that over-customization has created a technical debt that is stalling innovation and bloating budgets. If your RTSM system scalability is hindered by rigid architecture, you aren’t just facing a software issue—you’re facing a resource crisis.

The Trap of Custom Code and RTSM System Scalability

One of the most significant bottlenecks in traditional RTSM (Randomization and Trial Supply Management) is the reliance on custom code for simple change orders. When software isn't robust enough from a configuration standpoint, every minor adjustment requires a developer to write new code.

This creates a "black box" effect:

• Unique Codebases: Every system becomes a unique snowflake.
• Lack of Knowledge Transfer: If the original developer leaves, the new team must spend weeks reverse-engineering the system just to understand how it was built.
• Unscalable Workflows: This manual approach makes it impossible to scale across multiple global studies efficiently.

The "New Country" Litmus Test

A classic example of this inefficiency is the addition of a new country to a study. In a modern, configuration-based platform, this should be a simple task. However, in legacy architected systems, adding a country often triggers a multi-week re-testing effort.

When a "small" change requires a massive testing cycle, your timelines are naturally going to extend.

The Rising Costs of Technical Debt

As these systems grow more complex, the cost of maintaining them skyrockets. Clinical trial providers are currently facing two major financial pressures:

• Massive Backlogs: A backlog of manual changes leads to delayed study starts.
• Expensive Human Capital: Because the systems are so complex, they require increasingly expensive, high-level resources to manage and modify.

Year-over-year, the cost of the staff required to implement these changes rises, but the efficiency of the software stays the same.

The Solution: Building from the Ground Up

We have reached a tipping point where "patching" old systems is no longer viable. The industry expectation should be consistency and speed.

When RTSM systems are overly customized, they don't work consistently from study to study. Even "standard" features are often implemented differently each time, meaning a change to a standard feature in Study A won't work the same way in Study B.

To solve the scalability crisis, the industry must move away from custom-coded silos and toward platforms built from the ground up for configurability. Only by starting with a robust, standard architecture can we ensure that Atreo's clinical trial timelines are met and costs remain under control.

Key Takeaways for Clinical Supply Managers:

• Demand Configurability: Move away from vendors who require custom code for every change order.
• Prioritize Standard Features: Ensure that "standard" features are actually standardized across your entire portfolio.
• Evaluate Long-Term Costs: Look beyond the initial setup fee and consider the cost of future changes and resource requirements.