Two Makes a Team: How IRT/RTSM Work Alongside Supply Chain Teams
Randomization and Trial Supply Management (RTSM) and Interactive Response Technology (IRT) have long been utilised to manage patient randomization, drug distribution, and supply chain operations. These systems automate processes like enrolling and randomising patients, assigning treatments, tracking inventory, and monitoring compliance.
“Professionals outside RTSM and clinical supply chain often do not realize that IRT/RTSM is, at its core, a supply chain system. Every feature, workflow, and process should support medication management and supply chain operations.”
– Meghan Hasson, Senior Manager, IRT Supply Chain Systems at Deciphera
To celebrate the new Clinical Supply Chain Strategy and Optimization track at IRT & RTSM 2026, we interviewed some of our speakers on the impact IRT decisions can have on the supply chain, the importance of aligned IRT and supply chain teams, and the challenges their sessions at this year’s event aim to solve.
The IRT/RTSM build, and even the smallest decisions that come with that, can impact a clinical trial. Monica Eris, Global Supply Chain and Operations Executive, Executive S&OP, Clinical Development to Commercialization at Immugene, shares that IRT configuration decisions aren’t just a system setting – they directly influence inventory strategy, forecasting accuracy, operational flexibility, patient risk, and overall study cost. In her own experience, when the Clinical Operations team in one study wanted patients to receive six months of comparator supply immediately after enrolment, that seemed operationally convenient. However, it resulted in significant downstream implications for Clinical Supply such as:
- the depot inventory depleting earlier than predicted (even if, in reality, that inventory was now on site instead of in the depot),
- sites needing to store more inventory than necessary, creating risks particularly for temperature-controlled products, and
- tying up inventory that could have supported other enrolling sites.
Meghan Hasson, Senior Manager, IRT Supply Chain Systems at Deciphera, also highlights the risk of creating IRT/RTSM systems too narrowly around expected study scenarios without considering how the trial may evolve over time. Such approach can limit the team’s ability to adapt when unexpected situations arise and result in delayed decision-making, unplanned system modifications, supply chain disruptions, and increased costs.
Another speaker, who chose to remain anonymous, recounts a study with an ultra-expensive comparator where they used screening data and custom shipment calculations to better predict site demand. The result? Near-zero site drug waste. IRT/RTSM systems should not be configured independently as they are not executed in isolation and can have wide-spreading effects on the whole clinical study. As Monica puts it, “the relationship between IRT and Clinical Supply is continuous and highly interdependent where every change affects supply planning almost immediately”.
That is why the collaboration between Clinical Operations, or IRT/RTSM teams, and Clinical Supply are essential to the delivery of the study on time, on scope, and on budget. RTSM build discussions often unearth process questions which require alignment between both functions and leadership on key decisions, especially ones that may become SOPs. The exact SOPs that site staff will never see or read. That CRAs, ClinOps and Sponsor organizations aspire to earnestly deliver on, shares one speaker. Monica Eris recommends that Clinical Supply teams are involved in the study design.
“When both teams jointly evaluate enrollment assumptions, inventory strategies, and resupply logic early, companies avoid costly redesigns later in the trial. When these teams work together, organizations can reduce waste, improve forecasting accuracy, respond more effectively to changing enrollment patterns, and ultimately improve the reliability of patient supply.”
- Monica Eris, Global Supply Chain and Operations Executive, Executive S&OP, Clinical Development to Commercialization at Immugene
“The most successful organizations recognize that decisions made within the IRT have direct supply chain implications, and vice versa. Strong collaboration helps ensure systems remain streamlined, compliant, and focused on their primary purpose: getting the right medication to the right patient at the right time.”
– Meghan Hasson, Senior Manager, IRT Supply Chain Systems at Deciphera
As trials become more complex, IRT and supply chain teams must balance three competing priorities, highlights Monica Eris:
- uninterrupted patient supply,
- financial stewardship, and
- operational agility.
Strong alignment between IRT and Clinical Supply allows organizations to optimize inventory levels without increasing patient risk. That becomes especially important in cell and gene therapy, comparator-intensive studies, and global trials where products are expensive, manufacturing lead times are long, and regulatory expectations continue to increase.
Meghan Hasson emphasises that the greatest value comes from ensuring that IRT and supply chain teams have a shared understanding of the operational realities and bottlenecks within the clinical supply chain. As trial complexity increases, it becomes even more important that supply settings, inventory strategies, and resupply algorithms within the IRT/RTSM are configured to reflect real-world constraints and study-specific needs.
Sessions to Look Out for at IRT & RTSM 2026
You can find Meghan Hasson, Senior Manager, IRT Supply Chain Systems at Deciphera, at her presentation ‘IRT/RTSM 101 – Building Your Foundation in Clinical Trial Technology’ and at the panel session ‘Validate Smarter, Launch Confident – Modernizing IRT Validation and UAT for Today's Trials’. Meghan’s sessions will help attendees address two common challenges: applying a risk-based approach to User Acceptance Testing (UAT) and building a strong foundational understanding of IRT/RTSM systems. As clinical trials become more complex, teams need to prioritize testing in areas with the greatest potential impact on patient safety, study integrity, and supply continuity, rather than treating every test scenario with the same level of effort. Her IRT/RTSM 101 session, designed for early career professionals to build confidence in working with and supporting such systems, will leave attendees with practical insight into IRT/RTSM fundamentals and a clearer understanding of the critical role these systems play in clinical trial execution.
Monica Eris, Global Supply Chain and Operations Executive, Executive S&OP, Clinical Development to Commercialization at Immugene, will lead two presentations: One System, Many Markets – Managing Global Clinical Supply Complexity Through IRT and “Predict, Plan, Deliver –Redefining Clinical Supply Forecasting”. Monica wants attendees to leave with a practical framework for maintaining continuous alignment between IRT and Clinical Supply throughout the life of a study. She will share practical approaches for keeping forecasting assumptions, IRT configuration, inventory strategies, and cross-functional communication synchronized throughout the study to prevent teams from drifting apart after study startup. Ultimately, the objective is to maintain uninterrupted patient supply while balancing cost, inventory risk, and operational efficiency.
The IRT & RTSM 2026 conference is the key industry meeting where pharmaceutical manufacturers and solution providers come together to discuss how the IRT and RTSM landscape is evolving in response to increasing trial complexity, regulatory scrutiny, and supply chain pressure. This year IRT & RTSM 2026 tackle the problem of collaboration between IRT and clinical supply chain teams head on, with a brand new clinical supply chain track covering forecasting, waste reduction, and how smarter IRT and supply alignment drives better trial outcomes. Register today, for better clinical studies in the future.