Randomization and Trial Supply Management (RTSM) Systems are the most important clinical trial systems.  A single error with a drug assignment may impact the subject directly and compromise the trial’s integrity. A mistake in the overall randomization scheme could invalidate the entire study. Meanwhile, an effective RTSM system can be a powerful tool for optimizing material utilization, leading to substantial cost savings. To truly harness RTSM’s value, sponsors and suppliers need to implement strategic steps that minimize risks and maximize benefits. Success hinges on getting RTSM right—so let's discuss the “Hows” to make that happen.

Effective RTSM vendor onboarding is critical to trial success from the sponsor perspective. This presentation explores how early collaboration, radical transparency, and shared operational context enable stronger partnerships and better outcomes. We will discuss aligning expectations,
surfacing risks early, and building trust across clinical supply, clinical operations, and vendors to accelerate start-up, reduce rework, and create resilient, delivery-focused RTSM ecosystems that support scalable programs and consistent global execution worldwide today.

With over 22 different RTSM/IRT vendors available in the marketplace, standardizing system designs is a daunting but necessary challenge. This presentation explores how sponsors and vendors can identify which elements are best to standardize, align on a unified approach, and deploy standards across diverse platforms. Learn how to balance adaptability with consistency, navigate supplier differences, and evaluate the impact of standardization efforts across the industry.

RTSM has advanced from IVRS to today’s digital platforms, but what lies ahead? This session imagines the future of RTSM. How will science, technology, and culture transform RTSM and how will it adapt to meet the future of clinical research.

During this interactive session, we will discuss results from a recent study conducted by the Tufts Center for the study of Drug Development, focusing on (1) how U.S. clinical trial participants and sites perceive and experience Direct-to-Patient (DTP) shipments of investigational treatments, (2) the key benefits and challenges, and (3) actionable insights to improve patient satisfaction, site receptivity, and operational efficiency when using DTP shipments in clinical trials.

This presentation addresses how we can best prepare to align our processes to the risk-based requirements explicit in ICH E6 R 3? We will dive into meaningful steps and TMF documentation that will demonstrate Sponsor oversight in a quality-first clinical supply chain.

The fastest way to break trust in the vital Clin Ops/Clinical Supply relationship is when one party doesn't live up to their side of the deal. But where is "the deal" agreed to? What's in "the deal"? What happens when things change? What happens when assumptions are made that aren't the same on both sides? A Supply Plan Agreement can help reduce risk in the supply chain and create clarity and rules to operate. This session walks participants through things to include in an agreement and lifecycle management.

In today’s globalized and hybrid work environment, virtual teams have become essential to the success of Clinical Supply Operations. This presentation explores the key strategies for building and sustaining high-performing virtual teams within the clinical supplies domain. Drawing on real-world examples and industry best practices, we will examine how to foster trust, accountability, and clear communication across geographically dispersed teams.

Blood centers are an often overlooked source of biologic material and partnership for clinical trials and research. With existing GMP-compliant collection and manufacturing operations, capable logistics, advanced testing laboratories, and existing recallable donor bases, blood centers can offer a jump start to numerous product and project pipelines. This presentation will review our experience and capabilities as a community blood center, and how blood centers can adapt existing infrastructure to meet the needs of the advanced and cellular therapy industries to save lives in new and exciting ways.

FACT accreditation strengthens cell and gene infrastructure and is used as a measure of quality and safety by many stakeholders. This presentation will describe how FACT has leveraged its peer-to-peer framework to gather and act upon input from physicians providing or seeking to provide cellular therapies to make accreditation accessible to a growing diversity of providers. Solutions to this feedback will be outlined, including fit-for-purpose community clinical standards, provisional clinical accreditation, hub-and-spoke apheresis accreditation, education, and increased dialogue with industry and payers.

Point-of-care cell therapy manufacturing is expanding access, but success depends on infrastructure that clinical teams can operate reliably. This session outlines the practical cleanroom and facility requirements academic centers need to manufacture clinical material: compliant layouts, contamination control, GMP utilities, scalable workflows, and validation strategies that support QC testing and QA release. Attendees will learn how to right-size space, reduce operational burden, and design for growth without compromising patient safety.

Neurodegenerative conditions are prevalent and devastating diseases with severe economic, personal, and healthcare expense consequences. Cell replacement therapies have offered a route to functional recovery, but clinical cell manufacturing frequently requires distributed production and oversight associated with substantial financial burden. The present report will outline an in-hospital cGMP cell manufacturing facility with adjacent quality control and in direct proximity to patients, and demonstrate the challenges of developing a compliant and all-inclusive program at cost.

CBP will provide an overview of major U.S. regulatory authorities governing biological material importations, guidelines for acceptable and unacceptable cargo descriptions, examples of non-compliant shipments of biological materials and pharmaceutical products, and provide essential resources and important contacts for support.

The presentation outlines the role of the Pharmaceutical, Health, and Chemicals Center of Excellence and Expertise (PHC CEE) within CBP. It details the center’s structure, industry collaboration, enforcement responsibilities, and classification guidance for various pharmaceutical, healthcare, and chemical imports. It also highlights coordination with other government agencies and provides resources for compliance and trade facilitation.

Monitoring temperature control is a vital responsibility in clinical supply, extending beyond deep-frozen storage. Even products stored at ambient conditions require monitoring to ensure they avoid freezing or overheating. This session explains how tracking at defined supply chain touchpoints enables data collection, trending, and timely intervention. By leveraging value stream checkpoints, organizations can proactively maintain product integrity, safeguarding quality while minimizing risks across distribution and storage environments.

Kit wastage had spiraled beyond expectations—demanding urgent, strategic intervention. This talk presents our multi-pronged approach that includes addressing operational inefficiencies, refining processes with our partners, and empowering site-friendly practices to reverse the trend. Small, strategic shifts that build over time to reduce waste, boost efficiency, and embed sustainability into the fabric of clinical operations. Discover how a holistic strategy curbs waste and turns chaos into control.