The rise of radiopharmaceuticals represents one of the most exciting frontiers in oncology, yet it introduces a level of logistical complexity that traditional Clinical Supply Chain and RTSM systems were never designed to handle. Because these materials decay in hours rather than months, the operational window for patient administration is incredibly narrow, leaving zero margin for error. Success in these trials depends entirely on the seamless orchestration of manufacturing, logistics and site readiness.
This webinar explores the unique architecture required for a high-performing radiopharmaceutical RTSM. The featured speakers begin with a comprehensive overview of the radiopharmaceutical landscape, identifying the specific constraints, such as just-in-time manufacturing and rigorous cold-chain requirements, that differentiate these products from standard Investigational Medicinal Products (IMPs).
A core focus of the session is Smart RTSM Design. In the high-stakes environment of nuclear medicine, there is a temptation to over-engineer systems. The session will discuss how to build what is functionally “needed” to ensure supply integrity, rather than a “wish list” of features that add unnecessary friction. By prioritizing lean, responsive system logic, study teams can ensure that the “Right Kit, Right Patient, Right Time” mantra becomes a reality even under extreme time pressure.
Beyond the technical, the speakers will address the human element of clinical trials. Shifts in study personnel and leadership roles can create ripples of misalignment in long-term programs. They will also examine how a robust RTSM framework acts as a “source of truth,” providing continuity and operational stability even as internal teams evolve.
Finally, the webinar will tackle the inevitability of change through Advanced Amendment Management. In the world of Radiopharma, protocol pivots and supply chain disruptions are not a matter of “if,” but “when.” The speakers will share strategies for building an RTSM that is inherently flexible, allowing for rapid configuration changes without compromising the study’s data integrity or timelines.
Register for this webinar to learn how RTSM can help radiopharmaceutical trials manage supply chain complexity, maintain continuity and adapt to constant change.
Speakers
Katrien Aerts, Senior Clinical Trial Supply Chain Manager, ITM
Katrien Aerts is an experienced CMC Consultant and Operations Manager with a career-long commitment to excellence in drug development. From API to IMP, she has managed complex supply chains and commercial operations for some of the industry’s most vital products. Currently, Katrien leverages this deep operational expertise and passion to consult on the development of Radiopharmaceuticals and Advanced Therapies, helping organizations navigate the future of precision medicine.
Message Presenter
Siobhan McKenna-Power, Operations Manager, 4G Clinical
Siobhan McKenna-Power has over 20 years of experience designing and delivering regulated systems, with over 10 years of experience in designing and delivering RTSM systems for clinical trials. She first developed an interest in clinical trials when her father took part in multiple Phase III drug and device trials due to his progressive chronic obstructive pulmonary disease.
She was eager to contribute in her own way when the opportunity presented herself. Siobhan is a strong believer in first-time quality and works with sponsors to understand complex protocols. Siobhan has a keen understanding of what the needs of the end user are and works to ensure that even the most complex trials are easy for Investigators to work with and that patient safety is the foremost priority of any RTSM system.
Siobhan is a graduate of Maynooth University (formerly National University of Ireland, Maynooth) with a BSc in Computer Science and Software Engineering. She is currently working on a Level 7 Diploma in Risk Management.
Message Presenter
Neta Bendelac, Sr. Director, Strategic Engagement, 4G Clinical
Neta is a seasoned healthcare services leader with over 18 years of expertise in Clinical Supply Chain Management, serving as the Head of Clinical Supply organizations at global pharmaceutical companies. Her recent experience at 4G Clinical has been managing Strategic clients for RTSM, driving innovation and shaping 4G’s products to meet the industry needs.
Currently serving as the Senior Director of Strategic Engagement at 4G Clinical, she specializes in developing Account-Based Marketing (ABM) strategies for global pharmaceutical giants. With a background that spans leadership roles at major global firms and a deep focus on GMP/GCP, Neta excels at identifying industry trends and driving product innovation to meet the complex needs of modern clinical trials. She holds a BSc in Industrial Management Engineering and an MBA from Tel Aviv University.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Clinical Operations leaders involved in protocol development
- Clinical Supply professionals responsible for forecasting and strategy
- RTSM and IRT Specialists involved in study start-up
- Study Managers seeking clearer operational alignment across functions
- Operational teams preparing for upcoming trials and looking to strengthen foundational planning
What You Will Learn
Attendees will:
- Understand the specific supply chain triggers unique to radiopharmaceuticals
- Identify the “must-have” RTSM features for just-in-time clinical supply
- Strategies for maintaining study continuity through leadership and personnel transitions
- Learn Best practices for designing “change-ready” systems that thrive under frequent protocol amendments
Xtalks Partner
4G Clinical
4G Clinical’s suite of innovative RTSM and clinical supply optimization software provides the right-sized support for any phase or trial complexity. At 4G Clinical, all studies are supported by a team of RTSM experts to advise trial teams on the best path forward. Our operations team distinguishes itself through their extensive industry expertise and deep understanding of trial designs and mid-study adjustments. 4G Clinical is committed to helping sponsors and CROs follow the science, wherever it may lead, as quickly and as safely as we can. While we will not discover the next novel compound in the lab, we are doing our part by leveraging our extensive experience and technological innovations to bring speed and agility to clinical trials. As a critical partner throughout clinical development, we can help you seamlessly transition and scale your trials through both protocol and supply complexities to help bring crucial medicines to those who need them, faster. To learn more about how we are tackling the bottlenecks in clinical trials through our innovative solutions, Prancer RTSM® and 4C Supply®, visit us at www.4gclinical.com.
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