RTSM Reusability: What It Is, Why Most Systems Lack It, and Why It Matters 

If you work in clinical operations long enough, you start to notice the same pattern repeat. 

On the surface, many RTSM systems appear interchangeable. Yet as you move from one study to the next, or from one provider to another, the experience rarely feels as familiar as expected. 

What surprises many sponsors is not that systems differ, but that functionality assumed to be standard is often custom, fragile, and difficult to maintain. That surprise often turns into frustration once a study moves beyond initial setup and into UAT, maintenance, and mid-study change. 

This is not an isolated problem. It is structural. And understanding why it exists requires rethinking what RTSM actually is. 

 

RTSM Is Transactional by Design. That Makes It a System for Managing Change 

At its core, RTSM is transactional. Every interaction—screening, randomization, dispensing, shipment receipt, cohort movement—is a controlled transaction with downstream impact. 

That makes RTSM, whether we acknowledge it or not, a system for managing change. 

And here lies a fundamental conflict. 

Many sponsors still operate with an implicit desire for lack of change: finalize requirements early, minimize amendments, and avoid post-go-live updates. In theory, that desire makes sense. In practice, it conflicts directly with how clinical trials are actually executed. 

RTSM is typically designed and built at the final mile of study readiness, often in the last six to eight weeks before FPI. This timing is not a failure of planning. It is a rational response to uncertainty. 

Upstream systems are still evolving. RTSM inputs depend on EDC design, supply strategies, labeling decisions, country activations, integrations, and operational assumptions that are not fully resolved until late. Those “last-minute” updates are themselves changes. 

Ironically, the earlier an RTSM system is configured, the more change it will absorb before UAT even begins. 

 

Why Change Accelerates, Not Decreases, After UAT 

Once a system reaches UAT, it enters a new phase of risk. 

Changes outside of RTSM, protocol clarifications, operational decisions, integration updates, can still force updates to design or configuration before go-live. Any misalignment between sponsor expectations and RTSM implementation, even if not driven by protocol change, creates additional UAT churn. 

And once the system is live, reality takes over. 

Enrollment patterns differ from projections. Supply strategies adjust. Cohorts evolve. Amendments occur. Regulatory requirements shift. Each of these moments requires RTSM to change safely, predictably, and quickly. 

This is why focusing solely on go-live speed misses the point. The most vital part of RTSM delivery is not initial deployment, it is how well the system was designed to absorb change afterward. 

 

Most RTSM Functionality Is Already Well Understood 

Despite all this variability, most RTSM functionality is not novel. 

Across sponsors and studies, more than 80% of RTSM requirements are fundamentally the same. Screening flows. Randomization logic. Visit schedules. Dispensation rules. Shipment receipt. Reconciliation. 

Sponsors may have distinct procedural preferences or technical requirements, such as integrations with bespoke SAP environments, but those preferences are often consistent within an organization. 

When those sponsor-level preferences are applied at a reusable template level, functional reuse can exceed 90% from one study to the next. 

The problem is not a lack of commonality. The problem is how RTSM systems are built. 

 

Why Reuse Fails Even with Good Intentions 

All of this assumes—often incorrectly—that the RTSM provider is capable of managing their platform, templates, and studies in a structured way consistent with modern SaaS best practices. 

Even with strong sponsor standards, adequate lead time, and thoughtful decision-making, reuse breaks down if the provider cannot implement features uniformly. At that point, everything becomes custom in practice, regardless of intent. 

This is why some providers can promise reuse and still deliver bespoke systems every time. Without a stable platform architecture, “standards” simply become documentation artifacts, not executable reality. 

 

Platform RTSM vs. Bespoke RTSM 

Modern RTSM platforms can implement studies, including highly complex designs, entirely through configuration, often expressed as structured files such as JSON. 

In this model: 

• • Core functionality like screening, randomization, dispensing, and supply workflows lives in validated platform code 

• • Studies differ only by configuration, not by custom engineering 

• • The same base models run across all sponsors and all studies 

In contrast, legacy providers that promise “custom anything” often rely on fully bespoke code per study. Sponsors should assume—or explicitly verify—whether that promise implies 100% custom engineering every time. 

The difference is not cosmetic. It determines everything that follows. 

 

Why True Reuse Changes Everything Downstream 

In a platform-based RTSM: 

• • A screening update made for one study applies to all studies using that model 

• • Project managers learn the platform once and can support multiple studies with confidence 

• • Enhancements are not dependent on one individual who knows how a study was built 

• • Any qualified engineer can implement changes because the system is not dependent on individual knowledge 

• • Automation testing becomes feasible because the platform is stable and predictable 

As a result, enhancement timelines shrink, quality improves, and operational risk decrease, especially during the moments when change pressure is highest. 

This is not theoretical efficiency. It is structural leverage. 

 

Reusability Is How RTSM Preserves Institutional Memory 

Over long development programs, people change. Teams rotate. Context disappears. 

In bespoke RTSM environments, institutional memory leaves with individuals. Sponsors pay for that loss repeatedly through longer timelines, heavier oversight, and rework. 

Reusable platforms embed that memory into the system itself. Each study strengthens the next. The relationship becomes easier over time, not harder. 

That compounding effect is what sponsors actually feel, often without realizing why. 

 

A Practical Takeaway for Clinical Operations Teams 

Reusability is not a buzzword. It is a design choice that determines whether RTSM compounds value or compounds effort. 

When evaluating RTSM solutions, it is worth asking a question deeper than “How fast can we go live?” 

Does this system get easier to change as uncertainty accumulates, or does it become more fragile? 

RTSM is, by nature, a system for managing change. Platforms designed for reuse are built to embrace that reality. One-off systems are not. 

In today’s clinical environment, that distinction matters more than most teams realize. 

If you want to see what reuse looks like in practice, Korio was built around this exact model. We’re always happy to walk through how our platform handles change across studies, not just at go-live, but over the life of a program. Contact us to speak with an RTSM expert now.