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

• 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.

• Site perspectives on RTSM navigation

• Identifying opportunities for IRT enhancement and improving patient care

• Understanding general pain points and how IRT can improve them.

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.

• Discuss how to address the critical issue of inconsistency in the cost of IRT services by exploring strategies to enhance financial clarity while balancing the needs of sponsors and vendors

• Understand the challenges with promoting cost transparency with IRT services, and gain insights into effective pricing models while navigating key industry influences

• Learn strategies for recognizing proprietary technology differentiators among vendors and varying financial constraints within sponsors

• Contribute to a broader discussion on how the evolving nature of IRT technology can both improve and hinder efforts for more cost consistency and transparency

• Navigate the complexities of embedding device information into pharmaceutical products including privacy and regulatory concerns and selections of digital tools

• Discuss potential advantages and disadvantages of DHTs in clinical drug development

• Understand how digital resources can minimize environmental impacts and greenhouse gas emissions

• 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