At the SCOPE 2026 Summit in Orlando, Florida, Paul Hughesdelivered a presentation that stood out not for alarmism, but for optimism. Inan industry where Randomization and Trial Supply Management has historicallybeen discussed through the lens of risk avoidance, Hughes opened with amarkedly different tone. “I smell optimism,” he told the audience, underscoringa belief that RTSM has reached a level of maturity that allows the industry tothink beyond simply not failing.
Hughes’ talk, grounded in more than two decades ofhands-on experience, focused on what it truly means to get RTSM right and, moreimportantly, how organizations can move from correctness to optimization by2026. Below we will distill the core learnings from that session and frame themas practical guidance for sponsors, CROs, and technology providers navigatingthe next phase of clinical trial supply.
Hughes was candid about RTSM’s past. For much of hiscareer, success meant one thing: “I am just not going to ruin this.” GivenRTSM’s central role in patient safety and trial integrity, that mindset wasrational. Mistakes were catastrophic, and conservatism became ingrained in bothsystems and culture.
What Hughes emphasized at SCOPE 2026 is that the industryhas moved beyond that phase. “It’s not just risk avoidance anymore,” he noted.Over the past decade, increased collaboration, stronger vendors, and more opendialogue across organizations have enabled RTSM teams to consistently deliversystems that function as intended. That progress, in his view, creates thefoundation for something more ambitious: optimization .
One of Hughes’ first principles was deceptively simple:define your RTSM system. He challenged organizations to be explicit aboutwhether their platform is meant to be a broad, multi-purpose solution or afocused RTSM system built to excel at randomization and trial supply.
Reflecting on the industry’s legacy of “Swiss Army knife”IRT systems, Hughes was clear about his own position. “I am firmly in the campof RTSM,” he said, arguing that specialization drives clarity, efficiency, andaccountability. Regardless of philosophy, his message was consistent: thedefinition must be deliberate, communicated to partners and suppliers, andrespected over time.
A central theme of the presentation was what Hughesreferred to as requirements discipline. He cautioned against building solutionsin the absence of clearly defined processes and requirements, a pattern he hasseen repeatedly across organizations.
Drawing on a real-world example from the COVID-19pandemic, pharma companies we looking for ways to rapidly builddirect-to-patient shipment capabilities without any articulated requirements.“What are your requirements?” he asked at the time. The answer was simply, “Idon’t know. Just build something.” The conclusion in any instance like thisshould be direct: “You can’t build anything for which there are no requirementsand processes”.
The lesson is structural, not technical. RTSM optimizationrequires organizations to start with process and regulatory reality, deriverequirements from that foundation, and only then implement technology. Whenthose elements do not exist, RTSM teams must resist pressure to deliversolutions prematurely and instead work backward with stakeholders to establishthem.
Hughes also addressed a common inefficiency in RTSMdelivery models: overlapping responsibilities. He described scenarios wheresponsors, CROs, and vendors simultaneously attempt to gather requirements ormake design decisions, resulting in duplication and confusion.
His recommendation was the deliberate use of taskownership matrices and role specialization. By clearly definingresponsibilities through RACI models and allowing individuals to focus astesters, design leads, or project managers, organizations reduce redundancy andimprove execution quality. Hughes noted that this approach has enabled his ownteams to operate more efficiently and to engage vendors with clearer, moreactionable inputs.
Data was another area Hughes identified as a persistentsource of misunderstanding. He emphasized the importance of clearly definingRTSM data as transactional rather than clinical. An RTSM timestamp reflectswhen a system action occurred, not when a patient received treatment. Thatdistinction, he argued, must be understood across the organization to avoidunnecessary reconciliation and internal conflict.
“RTSM data is transactional data,” Hughes stated plainly.Clinical truth belongs in clinical data collection systems, not in RTSM.Without this shared understanding, teams expend significant effort attemptingto reconcile datasets that were never meant to align at that level .
Hughes wentfurther than simply emphasizing the importance of clear data definition; hedirectly addressed the industry’s persistent dependence on fragmented RTSM datasilos maintained on a trial-by-trial basis. This issue became particularlypronounced during the Ukraine conflict, which disrupted clinical supply chainsand affected pharmaceutical companies, CROs, CMOs, and other stakeholders. Whensenior leadership urgently needed visibility into shipments within the affectedregion, the lack of centralized data access became apparent. Teams were forcedto log into hundreds of individual RTSM systems to gather the requiredinformation, exposing a fundamental structural weakness in how RTSM data wasbeing aggregated and accessed across the industry.
“We can do better,” Hughes said. His vision for RTSMoptimization includes centralized, cross-study access to RTSM data, integratedwith other clinical supply information. This capability is not just aboutcrisis response; it is essential for informed decision-making at a portfoliolevel.
To illustrate the future of RTSM, Hughes used an analogythat resonated strongly with the audience. Today’s systems, he explained, arelike early GPS tools. They show the route, but humans must interpret conditionsand decide how to react. While useful, this model still depends heavily onmanual intervention.
The next step is autonomy. Hughes described a future whereRTSM systems respond dynamically to enrollment shifts, site inactivity, andenvironmental disruptions without waiting for human action. Supply levelsadjust automatically, waste is reduced, and resources are allocated based onreal-time conditions. In his words, the industry is moving toward“self-driving” RTSM systems.
Importantly, Hughes emphasized that the technologyrequired to support this vision already exists. The remaining barriers areorganizational trust, integration, and the discipline to define boundarieswithin which automation can operate safely.
Paul Hughes’ SCOPE 2026 presentation offered more than avision of the future; it provided a grounded assessment of where RTSM standstoday and what is required to move forward responsibly. The optimism heexpressed was not aspirational rhetoric, but a reflection of hard-earnedprogress across the industry.
RTSM Optimization by 2026, as framed by Hughes,is not about radical reinvention. It is about clarity of purpose, disciplinedexecution, proper use of data, and the thoughtful application of automation.Organizations that internalize these lessons will be positioned not just toavoid failure, but to deliver measurable value through smarter clinical trialsupply.