Day 1 - October 14, 2025Tuesday, 14 October 2025 - EST/EDT (Eastern Daylight, GMT-4)

Let’s imagine the future of Randomization and Trial Supply Management together. In this forward-looking session, look to a dream of the future and make some guesses at how RTSM might evolve over the next 25 years, highlighting pivotal shifts, breakthrough technologies, and the changing role of RTSM and industries place in it.

• Reimagine the future of RTSM Study Design and explore how personalized medicine and digital supply chains are transforming

• Harness the game-changing impact on new technologies like AI agents, IoT and quantum computing on trial management

• Examine the evolution of RTSM builds, from self-service platforms and customization to self-healing supply chains and test first builds

• Explore new approaches and new ways of thinking, for example will RTSM go away or will clinically build their own studies and amendments

The presentation introduces the fundamentals of GS1® data structure and standards. It further explains how these standards were utilized in a proof-of-concept pilot to demonstrate how GS1® standards are additive to supply optimization efforts. The pilot was initiated by the Clinical Supply Leadership Forum (CSLF) GS1® community of practice, led by Asim Kahn from Amgen and Hans von Steiger from Pfizer. During this pilot, the feasibility of streamlining site receiving and dispensing operations through connection of systems was demonstrated. Through collaboration, the pilot showcased how key aspects of clinical supply distribution and dispensing can be streamlined by leveraging GS1 identification and electronic data interchange (EDI) standards.

Key points that will be covered in the presentation:

• The use of GS1® compliant barcodes for product receipt and selection

• EDI messaging to reduce recipient data entry during receipt

• Elimination of redundant data entry

• EDI messaging to provide clinical pharmacy personnel with dispensing instructions

• Feasibility of connecting critical supply management systems via EDI messaging

• Explore how today's complex clinical trials demand more sophisticated RTSM systems and why sponsors need to move beyond traditional evaluation criteria

• Learn critical but often overlooked considerations when selecting an RTSM vendor, focusing on how modern technology is reshaping the landscape

• Gain insights into the full potential of advanced RTSM platforms and practical strategies for assessing whether vendors are leveraging these innovations effectively

An interactive session – offering knowledge and a dive into the big clinical supply chain questions. With its link into the clinical supply chain - IRT systems play a crucial part in supporting clinical supply forecasting. This in turn helps not only meeting sustainability goals, but bringing down wastage in trials, and leading to tangible cost savings to the sponsor. With AI being the new buzzword, we see how AI impacts the way these solutions work.

In this session we will:

• Look at the way IRT systems can interact / integrate with clinical supply forecasting solutions

• Explore why the connection between IRT and supply forecasting matters

As clinical trials grow in complexity, today’s IRT platforms have evolved from traditional RTSM engines into intelligent workflow integrators. No longer limited to randomization and supply logistics, IRT now connects patients, sites, and systems—serving as a central hub for operational efficiency, data transparency, and participant-centric design.

In this session, we’ll explore how modern IRT solutions are enabling smarter, more connected trials. We’ll also examine the strategic implications of this evolution—how to navigate rising complexity while delivering better experiences for patients and stakeholders alike.

Experts from Moderna and Endpoint Clinical discuss how integrating artificial intelligence into clinical technologies is driving new standards in data integrity, traceability, and regulatory readiness. Learn how AI is shaping a more adaptive and compliant future for clinical systems.

As clinical trials grow in complexity, the ability to adapt protocols dynamically—without compromising timelines, budgets, or compliance—is becoming a critical success factor. This session will explore:

• Real-world examples of IRT flexibility enabling successful protocol adaptations

• Technical and operational barriers to implementing dynamic protocols

• Strategies for balancing protocol agility with regulatory compliance

• Managing the impact of amendments on timelines, quality and cost

Explore how Agentic AI—AI that can make decisions and take action—can transform RTSM operations. This session will break down what Agentic AI is and how it differs from traditional automation. We will walk through practical applications in study setup, adaptive support, and intelligent helpdesk and have fun demo. Learn how this evolving technology can drive efficiency, accuracy, and innovation. Ideal for those ready to rethink what is possible in RTSM operations.

IRT process vary greatly from sponsor to sponsor so join us in discussions on:

• Obtaining optimal amount of data from clinical studies

• Navigating late-stage addendums

• Handling conflicts of using IRT for randomizations vs ancillary data