With the role of automating patient randomisation and supply management, IRT is a critical backbone for trial execution, yet it is often underestimated and perceived as a mere technical step before first participant in (FPI). Sites often don’t use it as much as other platforms and, by design, many of IRT’s core activities are invisible, leading to less awareness and an assumption of back-end simplicity.
These problems can have serious repercussions. When IRT set-up is handled as something of a checkbox activity and not considered strategically during protocol design, poorly implemented systems can result in delayed site activations, inefficient drug supply management, misallocations, potential unblinding of study data, and frustration across the board.
When designed well, however, IRT drives speed, flexibility, and quality across the trial lifecycle, even opening up opportunities to optimise patient randomisation strategies and visit schedules with relation to packaging configurations and allocation logistics.
A recent webinar shared how smarter approaches to IRT design can transform trial execution, improving data quality, operational efficiency, and sponsor oversight. Moderated by Clinical Trials Arena editor Abigail Beaney and sponsored by leading IRT company Perceptive eClinical, the session featured a joint presentation from Perceptive’s Robert Kothe, Technical Solutions Consultant, and Kendra Korte, Technical Solutions Consultant, followed by an audience Q&A.
After sharing some real-world examples of what can happen when IRT implementations are overlooked or left too late, the speakers focus on three important pillars of IRT designs to consider when evaluating vendors, including intuitive interfaces, protocol agility, and speed.
Intuitive designs
Intuitive IRT designs are essential for encouraging correct user behaviour and compliance. “When the user interface is clear and workflows are logical, sites enter data accurately and confidently,” says Robert Kothe. “That means fewer errors, less rework, and better oversight for sponsors.”
Intuitive designs typically provide step-by-step screens that follow a logical order with a clear breadcrumb trail, as well as handy features such as tooltips and hover text that offer clarification and definitions only when needed.
“We’ve seen studies where a confusing user interface led to incorrect dosing or missed visits, or where excessive alerting has led to cognitive fatigue and subsequent oversight,” adds Kothe. “The goal of alerting should be data accuracy and not user accountability. The IRT should only police critical elements that are pertinent to IRT behaviour.”
Kendra Korte agrees, adding that the user interface should ultimately make it easy for users to follow what needs to be done without being overwhelming. “If they’re faced with a wall of text, it is so much harder for users to identify what needs their input. […] We need to take that cognitive load away from the users.”
Protocol agility
When it comes to builds, Kothe and Korte discuss the careful balance between standardisation and flexibility. While standards give speed through automation, accelerating set-up and improving consistency, protocols are unique and often change mid-study, requiring customisation and flexibility. A happy medium lies in using pre-built validated templates, essentially “small pockets of standards”, says Kothe, that can be tweaked and adjusted throughout the trial, ideally via self-service controls.
“A strategic approach means building reusable components while allowing for controlled customisation,” he explains. “That way, you can adapt quickly to amendments without starting from scratch.”
Strong governance and transparency are essential when implementing standards: study teams need to be familiar with them and standards need to be maintained, updated and enforced to avoid miscommunication, confusion, and operational delays.
Korte says: “In our experience, we’ve seen that the best standards, the ones that are the easiest to use, are the ones that are enforced by both the vendor and by the sponsor. […] The more that can be standardised at the sponsor side as well as the vendor side, and the more communication there is around that, the easier it becomes.”
Faster start-ups
Every day lost before FPI costs sponsors money and delays progress. Korte explains that IRT is often required several weeks before FPI to support early packaging and shipment processes.
“With our Clinphone systems, we’ve developed some very robust processes that allow us to split go-lives, basically putting certain functionality live but leaving other parts disabled or on the testing environment. It means that in those cases where IRT is needed before EDC or any other system that we’re integrating with, we can put the main study design live in time for those inventory management and site initiation activities to occur and then activate the integrations once the other systems have completed the UATs.”
This is a great example of how smarter approaches to IRT unlock efficiencies for sponsors. Ultimately, for vendors like Perceptive, it’s critical that IRT is never the rate limiter for site activation. However, while speedy start-ups are essential, sponsors don’t want to sacrifice quality and future operational efficiency through poor or rushed implementations. Once again, a careful balance is key.
Watch the full webinar below
The session’s key takeaway is that IRT should be thought of as a strategic asset and enabler rather than a simple scheduling tool or a technical step needed before FPI. By considering IRT during early protocol planning stages and better aligning its design with study goals, sponsors gain opportunities to boost the operational efficiency of their studies and streamline the platform’s configuration and management, ensuring it doesn’t become a source of delay.
Meanwhile, when selecting a vendor that supports this need for smarter, strategic IRT, sponsors should prioritise intuitive designs, agility that doesn’t compromise compliance, and speed in builds and deployments.
To watch the full session, please download below.
