How Early Protocol Design Shapes Supply Strategy and RTSM Readiness

Early protocol design decisions carry significant operational consequences for clinical supply strategy and randomization and trial supply management (RTSM) performance. Many issues that emerge mid-study originate in assumptions, definitions or design choices made long before enrolment begins. This webinar brings together specialists from Converge, 4G Clinical and a sponsor representative to examine these early decisions from multiple operational perspectives, offering the type of insight typically gained only through direct collaboration with experienced partners.

Using protocol scenario as the anchor, the discussion will explore how design choices influence forecasting approaches, kit architecture, expiry strategy, pooling models, resupply logic and broader RTSM behavior. By analyzing these factors collectively, the panel will reveal how different stakeholders interpret the same protocol, where misalignment most often occurs and how early clarity can prevent downstream complications.

The conversation is designed to share expert thinking rather than case studies or product walk-throughs. The focus is on the practical considerations that senior supply professionals, RTSM specialists and study teams consistently prioritize when evaluating a new protocol. Attendees will gain a clearer sense of which elements of the protocol deserve deeper operational scrutiny, how to avoid assumptions that introduce risk and the types of questions that promote stronger cross-functional alignment from the outset.

The session will close with a brief look forward at how emerging technologies, including AI-enabled tools, may influence future protocol development and supply planning. This adds a measured horizon-scanning perspective, complementing the panel’s practical guidance.

Delivered jointly by 4G Clinical, Converge and a sponsor representative, this session brings together the operational viewpoints that most directly shape trial readiness, offering attendees a grounded and multifaceted view of how to design protocols that truly support execution.

Register for this webinar to learn how to assess protocols through an operational lens and strengthen both clinical supply planning and RTSM readiness from the start.

Speakers

Jennifer Cobb Foulkes, Practice Director, Clinical Supply Chain Services, Converge Consulting

Jennifer Foulkes is an experienced Supply Chain leader with 20+ years of experience in managing global supply chains, sourcing and inventory management. Foulkes specializes in clinical supply chain management with experience in all areas from starting up Phase I first-in-concept studies to managing and closing Phase III global double-blinded comparator trials. She advises clients on developing supply chain strategies that expedite FPI and provide long-term reliability to patients. Foulkes performs supply partner selections for packaging and IRT partners, implements and oversees the partnerships and serves as an SME when day-to-day support is required. She has implemented Sales and Operations Planning (S&OP) processes at numerous organizations, advising clients on inventory management strategies for all drug stages from raw materials to finished goods. Foulkes holds a BS in Management Engineering and an MS in Operations Design & Leadership from Worcester Polytechnic Institute. She is also a certified Lean Six Sigma Black Belt.

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Jennifer Teti, Vice President, Clinical Operations, Third Arc Bio

Jennifer Teti has over 25 years of comprehensive experience across all areas of clinical operations. While Jennifer’s career began in late development, the past 12 years have been focused on early development, where she has successfully led portfolios from first-in-human through proof-of-concept studies. She views each study as an opportunity to craft and execute the most effective operational strategy. Before joining Third Arc Bio, Teti served as Vice President of Clinical Operations at Scorpion Therapeutics and was previously a Senior Director at IMV, Inc. She also spent eight years at Johnson & Johnson (J&J), where she led global programs in Early Development Oncology and Immunology, working on over 20 drugs across multiple indications and modalities. Earlier in her career, Teti held roles at Roche, Shire, AstraZeneca, and Merck. She earned a BA in Psychology from Yale University.

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Savannah Holt, Delivery Operations Manager, 4G Clinical

Savannah Holt is a Delivery Operations Manager at 4G Clinical, where she guides complex project delivery and supports clients across the full RTSM lifecycle with a clear, operations-driven approach. She brings experience from Clinical Research and Development, having held roles in project management and Accounting and Finance at a publicly traded biotechnology company, which gives her a balanced view of scientific, operational and business priorities. With a Bachelor of Science in Microbiology from Oregon State University and a Master of Science in Healthcare Management at Oregon Health and Science University, she is passionate about strengthening operations in organizations which impact patient experience and access to care.

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(Moderator) Jonathan Pritchard, Director of Product Strategy, 4G Clinical

As Director, Product Growth and Market Strategy at 4G Clinical, Jonathan drives sales and product growth within the randomization and trial supply management (RTSM) market. His proven track record is built on extensive operational and sales leadership across the clinical trials ecosystem, specifically in medical devices, biostatistics and contract research organizations (CROs). His data-driven strategies are instrumental in identifying market opportunities and advancing innovative medical solutions.

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