Randomization And Trial Supply Management (RTSM) Systems: Meet Your Neighbor Again
By Paul Hughes, director of RTSM, J&J Innovative Medicine
RTSM systems have played a meaningful, though inconsistently defined and often unheralded, role in the clinical trial ecosystem for more than two decades. That is changing. RTSM is now positioned to serve a clearly defined and increasingly critical function in the clinical supply chain and the broader trial systems landscape. Today’s trials depend on RTSM as an enabler of a more efficient, optimized supply chain and reduced drug waste. Let’s discuss how organizations can prepare to capitalize on this momentum using a metaphor or two.
To provide context, RTSM systems originated as telephone-based interactive voice response systems (IVRS) in the late 1990s and early 2000s. The practical limitations of keypad entry forced narrowly scoped functionality (you may recall simple prompts such as “for X, enter 2–4”). As internet access became widespread in the early 2000s, the shift to interactive web response systems (IWRS) removed those constraints and expanded what was technically feasible. IWRS quickly became a solution for numerous emerging needs at a time when few other digital systems were available. As a result, IWRS was used for all sorts of non-RTSM functions, like subject number generation, eligibility data capture, various calculations, some data collection, and even eDiary capabilities. Over time, this broadened scope diluted the original RTSM focus and positioned IWRS as a multipurpose tool (the Swiss Army knife in your pocket) – useful, but not optimized for specialized, critical clinical supply tasks.
The Clinical Trial Systems “Neighborhood”
Now in the mid-2020s, the broader clinical trial technology landscape is growing and evolving rapidly, and many of these developments are very positive.
The clinical trial systems “neighborhood” has matured. EDC platforms are now pervasive and appropriately and clearly established as the primary data collection systems for trials. eCOA and eConsent solutions are widely adopted. Gone are the days in which IWRS was often the one and only digital trial solution. Instead, the landscape now includes a set of mature, purpose-built solutions, each serving a specific role within the broader clinical trial environment.
This raises an important consideration and opportunity: what improvements can be made within each system when those systems are designed to work as focused entities (no more Swiss Army knives) and then situated in our system neighborhood?
The neighborhood/community metaphor is a useful way to describe a well-integrated technology ecosystem: distinct participants contribute within their areas of expertise, strengthening the overall environment. As in a community, where a baker, nurse, teacher, and accountant each provide specialized value, clinical trial systems are most effective when each is purpose-built and then well connected. In this model, RTSM can return to its core mission because adjacent needs are addressed by its neighbors. This structure is particularly important in clinical supply environments where decisions in one system (for example RTSM) can directly influence the downstream supply planning, depot inventory positioning, and execution.
RTSM In Practice: From Design To Execution
A cohesive neighborhood will need a degree of management and structure. The key is to establish clear “sidewalks” and “fences.” Sidewalks represent shared standards, such as consistent nomenclature and data models, that enable reliable exchange of both metadata and operational data. Wherever feasible, shared data should be accessible through centralized, governed services (the neighborhood grocery store, if you will) that enable self-service for neighboring systems, rather than bespoke point-to-point deliveries.
Fences also serve an important role. While this may seem counter to the collaborative picture above, clear boundaries reduce ambiguity about system ownership and where specific requirements should be implemented. These boundaries are established through core business definitions, operating models, and policy documentation for each system. In some cases, a wise facilitator may be needed to define and validate these lines; once established, each system owner can focus on operational excellence and effective delivery.
With that context in place, we can focus on the RTSM “house.”
Today’s RTSM platforms are re-centered on their core purpose: randomization and trial supply management. This renewed focus benefits clinical trials by enabling more precise alignment between site-level demand and supply chain strategy. Modern RTSM solutions are feature-rich and specialized, allowing trial supply teams to configure supply approaches that reflect protocol requirements, site characteristics and activity, and operational constraints. In parallel, forecasting and modeling tools have matured into dedicated neighbors within the ecosystem, thus moving planning beyond ad hoc estimates and spreadsheets to robust methods that better account for the variability and inherent randomness of clinical trials.
Here’s how this benefits today’s clinical trials: Enrollment at an individual site has long been difficult to accurately predict. Enrollment is rarely consistent across sites, and it often fluctuates over time within the same site. This variability is driven by factors such as site activation timing, regulatory approval timelines, regional operational constraints, and the true unpredictability of human behavior. It challenges trial supply managers who sometimes struggle to keep supply settings aligned with real-world site activity.
RTSM platforms are increasingly able to detect potential misalignments (for example, repeated shipments to a single site) and recommend or automate adjustments. Detection is typically driven by real-time comparisons between expected enrollment curves and actual randomization or dispensing activity at the site or country level.
A site expected to enroll slowly may enroll at a rate well above forecast, while another site may not enroll for extended periods. In these scenarios, RTSM and integrated monitoring tools can identify the mismatch and prompt action or execute predefined mitigation steps. These adjustments may include changes to resupply quantities, depot-level allocation parameters, or site-specific shipment triggers, depending on how the study’s supply strategy has been configured within the system. Such capabilities can reduce administrative burden for clinical supply managers, improve drug utilization, and enhance the overall trial experience for sites and sponsors.
Operational And Economic Impact Of Modern RTSM
These advances also have a direct economic impact. Industry estimates commonly place drug wastage between 30% and 60% of manufactured supply. Shipping in alignment with actual demand, and avoiding unnecessary shipments, can reduce distribution costs and improve utilization. This is particularly relevant in oncology trials, where multiple comparators may be required at sites and can be expensive or difficult to source.
There is significant opportunity to use a focused, connected RTSM platform to drive meaningful efficiencies across the clinical supply chain. To realize this value, system strategists at sponsors and CROs should reinforce the neighborhood model: ensure each neighboring system is well-defined, well-designed, and high-performing, and ensure the ecosystem functions cohesively through shared standards (“sidewalks”) and clear ownership boundaries (“fences”). Within that framework, critical systems like RTSM are excelling and bringing improved value to stakeholders.
About The Author:
Paul Hughes is a longtime RTSM (IRT) professional currently serving as director of RTSM at J&J Innovative Medicine. Prior work experiences include RTSM roles at Pfizer and ClinPhone. In total, Paul has focused on RTSM for 25 years.
Paul’s focus now is to put his years as an RTSM subject matter expert into effective strategy and leadership that improves the RTSM space. Paul hosts RTSM Time, a periodic livestream on LinkedIn. Paul is also a founding officer of the RTSM Professional Society, the first organization focused on RTSM systems, professionals, and partners.
Paul was the recipient of Informa’s first IRT Lifetime Achievement Award in 2024.