Start-up Speed vs. Total Trial Success: Balancing RTSM Priorities  

When selecting a Randomization and Trial Supply Management (RTSM) system, are you balancing short-term efficiency with long-term success? Timeline efficiency matters at every stage of a clinical trial, and while build speed is an important consideration, it’s worth examining its broader implications. A fast build could indicate similar efficiencies once in Production—or it might signal more significant problems ahead.  

Consider this striking disparity: The typical clinical trial duration spans three to five years from first-patient-in to last-patient-out. Yet the average RTSM system build takes just four to six weeks—less than 5% of the entire study timeline. In the pressure-filled start-up phase when many study variables remain beyond a sponsor’s immediate control, quick RTSM builds offer tempting relief. But this focus on speed alone can lead sponsors to overlook critical factors that impact overall trial success 

The following explores various factors sponsors should weigh when selecting an RTSM solution and proposes strategies for balancing short-term startup efficiency with long-term trial success. 

Understanding the Real Tradeoffs of Accelerated RTSM Builds 

A swift RTSM build does not guarantee high performance throughout the life of the entire study. In fact, the vendor’s quick build commitment may not even guarantee a speedy trial start-up. 

Tradeoff 1: Limited Customization and Enhancement Capabilities 

Some vendors achieve startup speed by standardizing and limiting options. Your feature and functionality options may be restricted to what exists today in their system. Your flexibility could be completely bound by what their product technology allows. 

The real-world impact? Your team ends up creating manual workarounds to accommodate system limitations instead of having technology that adapts to your unique study requirements. Speed to setup often implies a lack of customization required or an appreciation of protocol uniqueness. Sponsors will pay in the long run because the system doesn’t do the nuanced things it should do because it was never mapped out upfront. This leads to complications during user acceptance testing and post go-live enhancements at sponsor expense—and unhappy users at the sites. 

Perhaps more concerning is the substantial risk that a system optimized for quick setup won’t be capable of evolving alongside inevitable protocol amendments. Just because a protocol fits a basic platform today, be very careful of the fact that it may not if or when a protocol amendment inevitably happens. 

Selecting a limited customization provider for setup speed forces you to start with a system that doesn’t fully meet your needs from the beginning and risks implementing an RTSM system that can’t evolve with your changing requirements for protocol amendments and enhancements post go-live. Neither scenario sets your trial up for success. 

Tradeoff 2: Resource and Quality Considerations 

What do you lose by prioritizing start-up speed over other considerations? The trade-off for a fast start up is a higher potential for issues due to insufficient thought and design that will require modifications once in the field. Study start-up and the initial go-live of RTSM is probably the most predictable and controllable piece of things. However, post go-live is when the sponsor really needs the RTSM provider to show up- the RTSM support model must have sufficient capacity, the agility to absorb change, and provide a high touch support to the sponsor—this is the most critical portion of the RTSM business. 

Iain Little, IRT Practice Lead with the life science consultancy Tenthpin, and former Team Head of IRT Management at Novartis, has experience in clinical research from the sponsor, CRO, and vendor perspectives.  

He believes overvaluing a fast RTSM build can come at a cost. “You’re paying for it somewhere else,” says Little. “Yes, it’s nice to go quicker, but without the mechanism in place to manage that, then you’re just asking for trouble.” Little believes that efforts to streamline study timelines can be successful only if fundamental processes and systems are updated. “If you don’t make any changes and simply say ‘do it quicker,’ then the quality is going to suffer. Corners get cut. Names of certain functions within the system get captured incorrectly. Integrations fail.” 

Build Time vs. Lead Time: The Critical Distinction 

When evaluating RTSM vendors, it’s crucial to look beyond the marketing claims about build time. A vendor’s promised timeline is just one factor to consider, and it may not accurately reflect the actual time to implementation. 

The distinction between “build time” and “lead time” is critical. Your vendor’s commitment to build time is not a guarantee of a speedy start-up if they don’t have the resources to begin that build right away. For example, a sponsor might award a contract based on the vendor’s projected four-week build timeline, but then the vendor may reveal that they cannot start the process for two or three months. Such miscommunications can double or even triple the start-up timeline, even before the study launch.Understanding these resource constraints is essential for realistic timeline planning. 

 “What does build time matter, if there are no resources to start now?” asks Madeline Tremont, IRT Manager at Genmab. Tremont points out that these projection inaccuracies on the part of RTSM vendors can have impacts throughout the course of the trial. The same resource limitations that exist during the build phase will also affect subsequent system update needs after the study is live. “That is a huge missing piece with study builds and enhancements to your system. That’s an important conversation to have.” 

A sponsor’s vetting process for RTSM vendors should include a discussion of the projected build time, as well as the vendor’s lead time for resources. 

 RTSM Must Synchronize with Your Entire eClinical Ecosystem 

“RTSM exists as the hub of an eClinical ecosystem with supplies, EDC and other integrations on every single study,” explains Chuck Harris, co-founder and COO of Korio. “The most strategic approach is to align the RTSM build with the other components of the ecosystem and arrive at user acceptance testing together. Rushing any one piece may just mean rework downstream.” 

While speed is valuable, it’s essential to understand how RTSM fits into the broader clinical technology landscape. The relative build and lead times for each system vary, but they inform each other through their design specifications. None can be developed in isolation from the others. 

The most effective implementation strategy synchronizes the RTSM build with other components to ensure thorough testing before go-live. This coordinated approach reflects the real-world experience of preparing all necessary components for a successful RTSM deployment. 

Beyond Start-Up: Optimizing for the Full Trial Lifecycle 

 Clinical trial sponsors face genuine time pressures during the start-up phase, making efficiency a legitimate priority. This isn’t about seeking instant results, but rather addressing a real business need. The desire for a fast, painless setup naturally reflects the intense resource demands of trial initiation. Acknowledging this reality is important when considering RTSM selection criteria. 

Post go-live has historically involved putting out fires when systems were set up incorrectly or unable to adapt as trials evolve over time. Sponsors can see a fundamental difference in the entire life cycle of the clinical trial by taking a forward-looking approach to RTSM selection. At the end of the study, sponsors won’t remember the four to six weeks it took to start up the study. They’ll remember the four to six years afterwards, where more attention to detail during setup coupled with a RTSM built to be adaptable mid-study with the long term in mind could have made a significant difference. 

Delivering It All: Speed, Quality, Adaptability, and Service Without Compromise 

At Korio, we’ve built an RTSM platform that solves the critical challenges facing clinical trial teams today. Our technology doesn’t force you to choose between fast implementation and long-term adaptability. Korio delivers: 

• Flexibility – Protocol amendments implemented at 50% of the time and cost through our modern architecture 
• Quality – Consistent excellence across your entire trial portfolio leveraging state-of-the-art technology 
• Expertise – Dedicated, seasoned project managers who stay with your study from kickoff to closeout 
• Focus – A purpose-built platform dedicated exclusively to RTSM excellence, not diluted across multiple product lines 

Korio’s approach transforms painful industry lessons into thoughtful design that empowers both our clients and our team. We understand that what truly matters isn’t just how quickly your trial starts, but how successfully it adapts and runs throughout its entire lifecycle. 

Experience the difference yourself by scheduling a demo to see how our RTSM platform handles the challenges of both today and tomorrow, keeping you Ready for the Trials Ahead™.