What would you do if your Randomization and Trial Supply Management system (RTSM) couldn’t handle your protocol’s latest amendment, or your RTSM provider’s level of service and support fell off from what was promised—with years still left in the trial?
When an active study encounters issues – whether in the RTSM software or with the vendor, the prospect of changing providers mid-stream can be daunting. But what was once viewed as a measure of last resort is now being evaluated by many clinical operations teams as a viable strategy for maintaining study integrity. This is reflected in industry conversations, where mid-study transitions are being discussed more frequently than ever before.
So, how do you know whether it’s time to make a change? And how do you make the transition without disrupting study operations and jeopardizing data integrity?
Fortunately, advancements in migration methodology have improved the reliability of system transitions, changing the risk-benefit calculation for sponsors facing significant challenges with their RTSM.
Signs that your RTSM vendor is underperforming
How do you distinguish between minor operational inconveniences and early warning signs of more serious system limitations? Some issues may seem manageable at first but could escalate into significant problems that jeopardize your study down the line.
Here are three indicators that your RTSM challenges might warrant more serious attention:
Declining responsiveness
You might notice your project manager seems overwhelmed with other priorities, enhancements and change requests take months to process, or perhaps the many layers to the RTSM vendor’s Support structure leave you interacting with personnel who are not familiar with the intricacies of your study. Constant delays and slow responses contribute to fatigue and potentially expose the study to disruptions and workarounds.
Perhaps you’re hearing reasonable-sounding explanations for these delays, but the pattern persists. In some cases, frequent staff turnover means you’re constantly dealing with new contacts who lack familiarity with your study.
When your needs consistently slide to the bottom of your vendor’s priority list, it creates incremental delays that can accumulate into significant timeline risks. Regardless of the underlying causes, if your RTSM provider cannot give timely attention to your requests, your study’s success may be compromised.
Functionality gaps
Your original RTSM solution may have performed well at study initiation, but as your protocol evolves through amendments, the system needs to keep pace. In the lifecycle of a clinical trial, emerging requirements often necessitate new RTSM functionality—particularly when studies grow in complexity.
When your current provider can’t implement these needed updates, you face a critical decision: either implement manual workarounds across multiple stakeholders (sites, study teams, supply chain) or transition to a more capable system. These workarounds not only create inefficiencies but can introduce significant data integrity risks by creating multiple sources of information describing the same protocol.
Once you’ve reached this functional impasse, the need for a mid-study transition becomes self-evident. The tangible impact on operations and data quality usually outweighs the perceived risks of transition.
Quality concerns
While occasional system issues can occur with any RTSM platform, the pattern and frequency of these problems can signal deeper concerns. When minor issues begin to accumulate, they often foreshadow more significant problems that could eventually disrupt your study.
A responsive vendor should resolve isolated incidents quickly with minimal disruption. However, when you notice a continuous pattern of quality issues accumulating over time, it suggests fundamental problems with either the system architecture or the vendor’s quality assurance processes. This “where there’s smoke, there’s fire” situation requires proactive attention.
Before these escalating quality concerns impact data integrity or site operations, considering a transition to a more reliable RTSM solution may be the more prudent path forward. The accumulation of small issues is often the warning sign that helps you avoid a major disruption later.
Changing RTSM Providers Mid-Study Is Risky — Here’s How to De-Risk It
Once you’ve recognized these warning signs in your current RTSM relationship, the next question is naturally: what can be done? While the prospect of changing vendors mid-study may seem daunting, advancements in migration technology and methodology have transformed what was once a high-risk undertaking into a manageable transition. With the right approach and tools, changing RTSM providers mid-study can represent a strategic investment in your trial’s success rather than a disruption to be avoided.
One such approach is exemplified by Korio’s data migration toolkit, a fully validated solution developed specifically for mid-study RTSM transitions. This toolkit has been successfully deployed across multiple global studies of varying complexity, enabling safe and efficient migration of patient and supply data.
What makes the Korio approach to mid-study RTSM transition easier and more cost-effective than ever?
- Modern platform approach. Korio uses a contemporary software platform with pre-built, standardized components that can be quickly combined and configured to meet study needs. This differs significantly from traditional RTSM systems, which typically require custom programming for each study—with all the time-consuming manual effort and testing that comes with it.
- Specialized migration toolkit. Enables efficient review, reconciliation, and validation of pre-cutover data prior to ingestion into the new RTSM system. This approach ensures that data from the legacy system is properly mapped to the new database schema, maintaining audit trails and data integrity throughout the transition. The structured process reduces the traditionally cumbersome task of manually preparing data for migration, shortening transition time and reducing opportunities for error.
- Comprehensive user testing. Before committing to a transition, sponsors can test a simulated version of the Korio RTSM with their actual migrated study data, allowing them to verify functionality and gain confidence in the system before go-live.
- Hands-on project management. The Korio solution includes highly qualified RTSM project managers who will provide guidance through every step of the migration process.
- Site-centric functionality. The Korio interface is designed with the site user in mind. Users can log in, view their tasks at a glance, execute transactions, and receive their confirmation message all through the same portal. It requires minimal navigation, and guidance tools are embedded on every page.
Is it time for you to change RTSM providers?
Are you dealing with an increasingly complex study or a substandard RTSM system? It could be for any number of reasons—your relationship with the vendor, the system quality, the wait time for enhancements. If you’re weighing your options, whether to hold steady with your current provider or to make the leap to a new one, these two considerations may help you decide.
Assess how much time remains on the study protocol. If you have another six months to go, it might be best to push through with your current provider. If you’re facing another few years or more, then imagine going through that much time with the same issues you’re currently facing. Is it worth the wear and tear on the site staff and your own employees? Is it worth the risk to your data integrity?
Request a consult with a new RTSM provider. To gain a complete picture of what the transition will entail, ask them to walk you through their migration process. Ask them what they can do to de-risk the situation.
Making the right decision for your study
While changing RTSM platforms during an active clinical trial requires careful consideration, the greater risk often lies in continuing with a system that cannot meet your study’s evolving needs. When partnered with an experienced provider that offers validated migration tools, the transition becomes a manageable process that can significantly improve your study operations, data quality, and site satisfaction.
If you’re experiencing functionality gaps, declining vendor responsiveness, or accumulating quality issues with your current RTSM system, now may be the time to explore your options. Schedule a 30-minute assessment with Korio to evaluate your current RTSM software and explore mid-study transition options