Day 2 - October 15, 2025Wednesday, 15 October 2025 - EST/EDT (Eastern Daylight, GMT-4)

Start your day with mindful movement in our Morning Chair Yoga session. This accessible 10-minute wellness experience is designed for all fitness levels and abilities. No yoga experience necessary – our certified instructor will guide you through energizing movements that help reduce stress, improve focus, and prepare you for a productive day ahead. Come as you are in comfortable conference attire and take a moment to breathe, stretch, and connect with colleagues before the sessions begin.

• Learn how a newly formed RTSM team at a mid-size biotech company established a governance-backed UAT process from the ground up.

• Phased approach for UAT revamp, using targeted workshops to surface challenges, identify risk-based/actionable solutions, and determine priority.

• Worked across a cross-functional team to align on RTSM UAT approach, receive governance buy-in, and create new process requirements/tools.

As the clinical research environment continues to evolve, so too does the technology supporting it. One notable development is the transition of RTSM platforms to a Software-as-a-Service (SaaS) model. In this session, explore how SaaS-based RTSM platforms are transforming study design and execution.

• Examine how user interfaces and configurable frameworks are helping clinical teams reduce their dependency on custom development and accelerate trial startup

• Discuss real-world examples illustrating how teams are leveraging SaaS-based RTSM to manage protocol needs more efficiently

• Learn about metrics related to time and cost efficiencies, as well as the broader implications for compliance, scalability, and cross-functional collaboration

This session explores strategies for enhancing Randomization and Trial Supply Management (RTSM) systems by prioritizing the needs of clinical sites—the primary users who often have minimal input into system design. Learn how site-focused improvements can create more efficient, user-friendly RTSM experiences that ultimately benefit patient care.

• Discover effective methods to incorporate site feedback into RTSM design, creating systems that better serve the needs of those who use them most frequently while reducing training time and user errors

• Learn practical approaches to streamline time-sensitive processes like drug reconciliation and data entry, helping sites manage patient visits more efficiently and reduce treatment delays

• Explore real-world examples of how enhanced inventory visibility tools have prevented supply shortages, minimized patient turn-aways, and improved overall trial continuity at clinical sites

Priorities are seemingly in conflict between trial sponsors and clinical sites. Both clinical sites and sponsors seek to meet their own regulatory requirements and need to efficiently and consistently manage IMP but are often taking divergent paths. While many sponsors would like to mandate the use of their IRT systems to manage all IMP returns and destructions, sites increasingly choose to utilize their own standardized processes instead and may use third party drug management systems instead of IRTs. In this panel, we will discuss diverse perspectives on the challenges and opportunities in investigational drug accountability management.

As IRT platforms evolve with greater configurability, the dynamics between sponsors and vendors are transforming. This session explores the financial implications, operational realities, and future workforce considerations in modern IRT implementations.

• Explore how increased configurability in IRT platforms is changing the landscape for sponsors and vendors, impacting both implementation speed and overall cost structures
• Tackle the ongoing debate around "no-cost" change orders and what they truly mean in practice for both sponsors and service providers
• Examine how budget pressures, formalized change order processes, and automation are reshaping vendor/sponsor relationships and transforming the roles of IRT professionals

• Advantages and challenges of adopting DHT in drug trials
• How to navigate regulatory expectations for drug submissions
• Future outlook: how DHT will transform trial design and execution

• Identify and establish different metrics taking into consideration

• Navigate the complexity of contract management between sponsor companies and multiple vendors

• Discuss legal roadblocks in IRT in relation to artificial intelligence

• Develop practical timelines in building RTSM study systems