Leadership engagement on both sides was repeatedly cited as essential when challenges inevitably arise.<\/p>\n
Many issues attributed to vendor performance ultimately stem from misalignment at the outset. When expectations are unclear or the relationship foundation is weak, every downstream activity becomes more difficult.<\/p>\n
Standards Create Leverage\u2014When Applied Thoughtfully<\/h2>\n
Standardization remains one of the most effective ways to manage complexity, especially for organizations working with multiple RTSM vendors or advanced study designs. This is particularly true as clinical supply and RTSM become more tightly linked across systems and workflows. But the message from speakers was clear: standardize where it removes friction, not where it restricts necessary flexibility.<\/p>\n
Well\u2011designed standards bring consistency to identifiers, timelines, governance, and baseline workflows. They reduce rework and ambiguity while still allowing room for innovation. And they must be treated as living guidelines that evolve alongside technology, processes, and organizational maturity.<\/p>\n
A recurring insight across the track was that internal alignment is often harder than vendor alignment. Without shared understanding across clinical operations, data management, biostatistics, quality, and supply chain<\/a>, even the strongest standards struggle to take hold.<\/p>\n Despite years of system evolution, the site experience remains a persistent pain point. The feedback across sessions was clear: sites want to get in, complete the task, and move on.<\/p>\n Every extra confirmation screen, unclear error message, or unnecessary workflow step adds cognitive burden. Over time, sites compensate by using workarounds, such as over\u2011ordering, manual tracking, or reverting to paper. Each of those workarounds introduces new operational and supply risks.<\/p>\n Designing RTSM systems with the site\u2019s needs in mind is not only about improving usability but also a practical and measurable strategy for mitigating risks.<\/p>\n The discussion around digital protocols highlighted a clear industry shift. Structured, machine\u2011readable protocols are no longer aspirational; they are becoming essential to modern trial execution.<\/p>\n Digital protocols support more reliable downstream configuration across RTSM, electronic data capture (EDC), electronic clinical outcome assessment (eCOA), labeling, and supply systems. They improve amendment clarity, strengthen impact assessment, and create the conditions needed for automation and true interoperability.<\/p>\n Most organizations are still early in this transition, but the trajectory is unmistakable: digital protocols are emerging as core infrastructure for clinical trials.\u00a0<\/strong><\/p>\n Artificial intelligence (AI) surfaced across many discussions, but the most compelling use cases were grounded in practical validation rather than futuristic automation. Today, AI delivers the most value as a quality\u2011assurance support tool through flagging inconsistencies, confirming accuracy, and supporting human review.<\/p>\n Examples included detecting inadvertent unblinding, validating protocol amendments, and reviewing supply or labeling documentation before approval. Across all use cases, the principle was consistent: human oversight remains essential, but AI can significantly reduce rework and strengthen right\u2011first\u2011time outcomes.\u00a0<\/strong><\/p>\n The most thought\u2011provoking session of the track came from Barry Moore<\/a> of GSK, who pushed the audience to look beyond near\u2011term optimization and consider the long\u2011term evolution of RTSM.<\/p>\n He traced the progression from paper\u2011based processes to interactive voice response systems (IVRS) to today\u2019s RTSM platforms, then projected forward\u2014five, 10, 25, and even 50 years. Along that horizon, he explored how several forces could fundamentally reshape RTSM and clinical research:<\/p>\n One particularly compelling idea was the possibility that RTSM could shift from supporting discrete trials to enabling continuous, personalized intervention\u2014blurring the line between research and routine care.<\/p>\n Whether or not every element of that vision comes to pass, the takeaway was unmistakable: the architectural decisions we make today\u2014around data structure, standards, and interoperability\u2014will determine whether we enable future innovation or accumulate technical debt that limits it.\u00a0<\/strong><\/p>\n Dan McDonald giving remarks as chair for the IRT\/RTSM: Navigating the Digital Neighborhood session<\/p><\/div>\n The clearest takeaway from chairing this portion of the track is that while progress in clinical supply and RTSM is improving, progress will not come from technology alone. Organizations that treat them as an integrated discipline will be better positioned for future challenges.<\/p>\n Effective progress will come from clearer onboarding, smarter standards, stronger internal alignment, and greater empathy for sites, all paired with the discipline to think long term. These themes are not theoretical; they are operational realities that directly affect how studies are launched, managed, and sustained in the real world.<\/p>\n The future of RTSM is being shaped now, through the decisions we make and the structures we choose to build.\u00a0<\/strong><\/p>\n The themes from this year\u2019s track\u2014clear onboarding, stronger alignment, and reduced operational friction\u2014reflect the way Imperial approaches clinical trial support. Our single-workstream model consolidates ancillary supplies and equipment, kitting, study materials, translation, and logistics under one coordinated team, led by a dedicated project manager who ensures continuity across timelines and deliverables. By consolidating services, we help sponsors reduce complexity, strengthen communication, and keep studies moving with fewer handoffs and fewer surprises. Visit our website<\/a> or click the Contact Us button for more information.<\/p>\n Thank you to Scope 2026<\/a> for another great conference!<\/p>\nThe Clinical Site Experience Still Needs Greater Focus<\/h2>\n
Digital Protocols Are Becoming Core Infrastructure<\/h2>\n
AI\u2019s Greatest Value Today Is Validation<\/h2>\n
A Standout Perspective: Clinical Supply and RTSM Through 2075<\/h2>\n
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Final Reflection<\/h2>\n
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The Imperial Advantage<\/h2>\n