Agenda for Day 1 – Tuesday October 6, 2026Tuesday, 6 October 2026 - EST/EDT (Eastern Daylight, GMT-4)

IRT/RTSM has evolved from a functional tool into a strategic driver of clinical trial success, operating at the intersection of clinical operations, supply chain optimization, and trial delivery.

This collaborative session examines how leading pharmaceutical organizations are building scalable, enterprise-level RTSM programs that accelerate speed-to-live while strengthening clinical supply chain resilience: 

• Analyze the forces reshaping IRT/RTSM in 2026, including trial complexity, global supply chain volatility, resource constraints, and rising regulatory expectations

• Evaluate how establishing global standards and configuration libraries reduces UAT cycles while maintaining protocol flexibility across complex supply chains

• Explore strategies for creating a "Single Source of Truth" that provides real-time visibility into patient randomization, clinical supply inventory, and depot management

• Examine how integration architecture (bridging CTMS, WMS, EDC, and eCOA) streamlines operations and enhances clinical supply chain strategy in today's volatile environment

Protocol amendments are a reality of clinical trials, but their impact on timelines, budgets and data integrity doesn’t have to be. Delve into practical strategies for designing and managing IRT systems that are built to adapt to change.

• Understand the value of involving IRT early in protocol design to minimize the need for downstream amendments

• Explore proven approaches to managing mid-study changes seamlessly using clinical technology solutions

• Examine where the industry is heading on self-service capabilities and what sponsors should expect from their platforms today

AI is transforming the clinical supply and RTSM landscape, but separating hype from reality is critical. This session takes a pragmatic approach to understanding how AI can deliver tangible value while addressing the complexities of integration in regulated environments.

• Investigate real-world AI applications in RTSM today such as supply forecasting, study setup and beyond

• Understand how to design systems and workflows that effectively incorporate AI tools into clinical technology to enhance solutions and drive operational efficiency

• Address the tough questions around AI in GMP-regulated environments, including validation, oversight and regulatory acceptance

• Differentiate meaningful AI integration from marketing buzz and understand what successful integration looks like in practice

Sites are the end users of every IRT system, yet their voice is rarely centered in the conversation. Incorporating the site’s perspective will reveal an honest look at what’s working, what isn’t, and what sponsors and vendors need to hear.

• Hear directly from site representatives on the day-to-day realities of working with IRT systems

• Discuss how usability challenges and training gaps are impacting site performance and patient engagement

• Identify what better IRT design and support could look like from the site's point of view

As IRT programs scale across studies and portfolios, disconnected data is becoming one of the industry's most pressing and least discussed challenges.

• Develop strategies for aggregating and standardizing IRT data across multiple studies and deployments

• Tackle the emerging complexities of data retention post-site closure and what sponsors are accountable for

• Assess how improved interoperability between IRT and broader eClinical systems can reduce reconciliation burden and improve decision-making

A dedicated working session led by the RTSM Professional Society where thought leaders can come together to advance the industry’s standards.

• Review the current state of IRT and RTSM standardization efforts

• Identify priority areas for standards development and consensus building

• Align on next steps and the path forward for the RTSM Society's standards work

Where smart testing meets modern compliance — closing the gap between build, verify, and go-live.

• Explore how the shift from CSV to CSA reshapes UAT design, compresses timelines, and reframes what "done" looks like before go-live

• Identify where clinical operations teams get frozen out of the IRT build process - and how upstream integration eliminates the failure points that derail testing

• Examine what regulators expect from IRT validation in 2026 and walk away with a practical framework for moving faster without sacrificing compliance or data integrity

• Investigate the regulatory and labeling challenges of managing clinical supplies across multiple countries and regions

• Discuss how IRT systems can support depot management, resupply, and inventory optimization at a global scale

• Examine strategies for maintaining clinical supply chain resilience across diverse geographies and trial environments

• Navigate the complexities of managing IRT across large, global trial portfolios

• Share approaches to vendor governance, standardization and cross-functional alignment

• Exchange candid perspectives on what's working, what isn't and where the industry needs to go

• Discuss what standards compliance looks like across sponsors

The conversation doesn't stop at the breakout door. Come back together to share what surfaced in each group, identifying common themes, shared challenges and opportunities across organization sizes, and sparking dialogue across the full community