Randomization and Trial Supply Management (RTSM) providers must respond to the increasing complexities and adaptive nature of clinical trials today. Gone are the basic studies, and in their place are highly sophisticated trial designs that reflect the
evolving science of new medicine development. If clinical trials themselves have continuously advanced, why is RTSM mired in best practices and techniques of the past? Simply put, what worked once before no longer works now, and the quality issues that ripple across our niche are evidence of the need for change.
RTSM Testing Legacy: Searching for a Needle in a Haystack
The industry’s approach to building quality into RTSM systems has often come through testing practices which have remained largely ‘manual’ throughout the years. In most cases, teams of people are assigned to test aspects of a given IRT system by hand as it is developed; the testing scope for this work is ‘100% of the system- everything’, but the number of combinations of scenarios and events is far beyond the bandwidth of an individual tester’s fingertips to verify in a reasonable amount of time.
Further compounding the time-sensitive nature of our work is that a given RTSM system in development changes frequently throughout the testing process (a different but important issue) – as bugs are identified and fixed, the test engineers must then go and repeat the entire suite of testing for the fixed feature, as well as retest or regress all potentially impacted areas around that item. What a tall order we place on our test engineers!
The ripple effect of trying to manually test a complex system in flux means that testers are often simply playing whack-a-mole finding bugs everywhere instead of systematically and confidently validating end-to-end RTSM system health.
Good News: Automation
Where manual processes simply can’t keep pace with RTSM’s evolution and inherent complexities, an entire industry-agnostic discipline has been developed around technology automation – one key aspect of this automation framework is testing itself.
You might then wonder – what does ‘testing automation in RTSM’ mean? Will testing automation make my next system bug-free? What about people – do robots test my study without human involvement? Perhaps most importantly, why should I care about this topic in the first place? In an ideal world – and what we believe is the achievable state for RTSM providers – you should not have to care at all because it’s ‘just there’ as part of each RTSM delivery!
RTSM providers can employ a host of automation tools to achieve a systematic and holistic approach to improved quality in a more rapid and repeatable manner. With a proper testing automation framework, mid-study changes can be implemented faster with fewer headaches. UAT can then resemble true acceptance testing instead of ‘re-testing’, and risk can be quantified and mitigated for each RTSM system go-live. The downstream impacts of properly conceived automation practices can be very powerful – read further to hear how it can improve your RTSM journey.
Testing Automation: The Basics
Automation testing employs specialized software tools to execute scripted test scenarios on a software application – in our case, this is the RTSM platform or individual study itself. The scenarios can be run early and often throughout all phases of the delivery lifecycle, including post-go-live for ongoing surveillance.
Examples of what this automation testing can do:
- Verify all ‘base’ system functionality (i.e., visit workflows, notifications, etc.) end-to-end.
- Simulate all possible user entry combinations and system responses for each trial design.
- Create thorough, objective human-readable testing evidence.
- Provide detailed reporting to quantify quality.
- Run overnight or ‘in the background’ to provide continuous testing coverage.
Like all systems-level approaches to improved outcomes, testing automation used alone in a silo does not create quality outcomes. Testing automation capabilities can be more fully realized when they are applied to an RTSM automation framework on a modern tech stack with a stable RTSM platform data model. As well, automation and testing automation is a highly specialized discipline which rewards the right combination of people, process, and tools to optimize its effectiveness. While automation offers better solutions than merely adding more people to enhance RTSM testing coverage, it does not replace the criticality of human expertise in the setup and maintenance of the automation framework itself, or in the interpretation of the test results.
RTSM: Applying Testing Automation in the Real World
Let’s talk about a few examples that should bring this all together:
Verification of Inventory Updates in RTSM:
When supplies are shipped to a site or assigned to patients, the RTSM system updates its inventory and peripheral aspects of the RTSM accordingly (e.g., integrations, notifications, reports, etc.). Automation testing can simulate these inventory-related changes by running pre-defined scripts that check whether:
- The stock levels decrease correctly when treatments are assigned
- The inventory is updated properly after a resupply is received
- Alerts are triggered when inventory levels drop below a defined threshold
This kind of repetitive, predictable task can be easily automated because the expected outcome is always the same: the system either makes the various supply updates across the application as expected or it doesn’t. Automation tools can run these checks across hundreds of variations (e.g., different medication types, dosages, sites) in a consistent, repeatable way and generate human-readable reporting for validation evidence.
Handling a Mid-Trial Protocol Amendment:
Imagine that halfway through a clinical trial, the protocol changes to include a new randomization stratification factor. Implementing and testing this change involves complex decision-making, creativity, and a deep understanding of the trial’s specific goals and the state of the RTSM data in the system pre- and post-update. Test engineers need to:
- Ensure that the new randomization logic is correctly integrated with the existing stratification.
- Analyze the ripple effects of the change on workflow, notifications, reports, integrations, and other study-specific configurations.
- Review real-world scenarios where the new rules might conflict with existing ones or trigger unforeseen edge cases (e.g., impact on patients enrolled under the old schema).
These tasks require nuanced judgment, domain expertise, and adaptability – elements that are beyond the scope of basic automation, which relies on predefined inputs and expected outcomes. Humans excel at handling these kinds of dynamic, scenario-specific challenges. Once the problem set is fully understood, the manual testing can then be automated to run again and again as needed.
Unleashing the Power of Automation: Four Key Benefits for RTSM Testing
In summary, testing automation is a powerful strategy your RTSM provider can use to enhance its existing manual testing capabilities:
- Improved Focus: While automation handles wide-scale, repetitive, time-consuming tasks, manual testers can focus on unique complex scenarios that require human intuition and creative problem-solving prior to automation.
- Expanded Coverage: Automation tools can run thousands of test cases rapidly, providing far more comprehensive coverage than manual testing alone. This solidifies foundational aspects of software where people cannot reasonably be expected to manually test and re-test the same basic code time and again at every phase of delivery.
- Consistency: Automated tests perform the same steps precisely every time they run, eliminating the variability that can occur from one individual to another (experience, expertise, time constraints, etc.) that impact manual testing.
- Efficiency: Automation allows tests to be run frequently – overnight or during off-hours – providing rapid digestible feedback to development teams that enables uninterrupted engineering delivery.
Korio: Your RTSM Experts
Don’t wait for the next software bug to delay your study. Schedule a demo with us today and discover how Korio can streamline your trial’s randomization and supply management, delivering both speed and confidence every step of the way.
Schedule a demo and see why Korio is Ready for the Trials Ahead™.