The Interactive Response Technology (IRT) market continues to grow from its humble origins, with one report valuing the IRT market at $1.2 billion in 2022, expanding at a CAGR of 14% between 2023 and 2030.

IRT systems help sponsors ensure that the right supplies go to the right patient at the right time. Today’s IRT systems are advanced SaaS technologies that integrate with other eClinical solutions to enhance efficiency and data integrity. But to get to this stage, IRT has undergone numerous iterations.

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The pre-digital need for IRT

IRT was developed in the 1970s with the goal of addressing several pressing challenges in clinical trials. Until IRT, participants were randomized manually, often with sealed envelopes, introducing the risk for human error and bias which was affecting protocol compliance and statistical integrity. Meanwhile, drug supply management was paper-based and often ad-hoc, with no real-time view of supply levels at sites. This meant that drug waste was a common issue, with sponsors making the costly but necessary decision to over-supply sites in order to avoid stock-outs.

“The early systems for IRT were based on interactive voice response technology and relied on touch-tone keypads to allow site staff to enter patient data via the telephone keypad,” says Shaun Hopgood, COO, Perceptive eClinical. “They would then receive randomisation assignments via voice or fax. Whilst better than manual processes, it was still a cumbersome and error-prone process with significant limitations and no real-time view of the data.”

In the dawn of digital, Interactive Web Response Systems followed, with IRT shifting to computer-based systems. The internet provided better data visibility, allowing IRT providers to automate drug supply logistics with real-time inventory tracking and resupply triggers. Integrations with other eClinical solutions such as electronic data capture (EDC) also became possible, paving the way for the more dynamic displays and multi-entry transactions we see today.

Modern IRT systems have come a long way from those early solutions, with a new focus on process orchestration and improving how data is collected, processed, and used. Most systems are now cloud-native SaaS and have advanced capabilities when it comes to managing drug logistics, ensuring appropriate just-in-time supplies even under the complexities of adaptive and decentralised trials. The current emphasis is on the tech’s ability to predict a trial’s supply needs to further reduce cost and waste. Self-service has also become increasingly important for sponsors and sites, who have witnessed IRT’s shift from customised solutions to configurable ones.

“The cloud technology stack upon which IRT systems are delivered today has driven significant changes in the way that systems are built and delivered,” adds Hopgood. “The use of microservices has led to the modularisation of platforms that are easier and faster to assemble and upgrade.”

Beyond new capabilities, a fresh acronym also entered the picture. Randomisation & Trial Supply Management (RTSM) has been used interchangeably with IRT for years, providing a more specific representation of what these systems provide.

“Randomisation and Trial Supply Management is the core of what we do; not every study uses every facet but ultimately it all comes back to treatment assignment and material management,” says Hopgood.

IRT now “mission-critical” for sponsors

Mario Papillon is the CEO of Perceptive eClinical. He explains that IRT’s evolution encompasses far more than new acronyms and abilities. “Perceptive started its life as ClinPhone and were the first RTSM provider back in the days of envelopes and touch-tones. Since then, we’ve grown in every way and have extended our product and service capabilities to handle simple and complex trials in multiple therapeutic areas and trial phases, globally.

“One thing we’ve witnessed along this journey is the transformation of RTSM from a specialist system to a core system that is mission critical in trial execution, particularly with the increased regulatory burden and the increasing complexity of trials,” he explains. “IRT is often called out in protocols and is used to automate a wide variety of protocol requirements, such as complex or adaptive cohort assignment, unique randomisation methods and multi-phase designs.”

Another trend is the changing types of trials that now rely on IRT/RTSM, from growing adoption in early phase trials to its use across expanding trial geographies and therapeutic areas, as well as decentralised trials.

Sponsors developing drugs with high manufacturing costs are also benefitting from IRT’s prominence in these areas, helping to reduce drug wastage and therefore cost per patient. Ensuring that the industry’s latest IRT products are set up to handle the complex supply chains of orphan drugs and personalised medicines is a key focus for Perceptive eClinical, says Papillon.

“Our systems can handle just-in-time and participant-specific manufacturing, both of which are set to become increasingly important as the pipeline of personalised medicines grows,” says Papillon. “If you look at the opportunities and unmet needs in rare diseases and the rise of innovative modalities like radiopharmaceuticals and cell and gene therapies, it’s clear that the future of pharmaceuticals lies in personalisation, where medicine is not one-size-fits-all but a precise response to unique biologies.

“RTSM is the engine behind this transformation and will help sponsors of high-value drugs overcome key challenges associated with complex trial designs, medication pooling, high unblinding risks, and Just in Time designs.”

As the industry’s first provider of RTSM, Perceptive eClinical has an impressive track record, with more than 5,600 studies under its belt. The company has supported upwards of 500 successful regulatory submissions, and many of the world’s leading IRT professionals learnt the market during their time at the company. All of this experience stands the company in good stead to write the future of IRT while leaning on decades of sponsor feedback and a legacy of regulatory compliance.

“We are adaptable to the client’s needs, without sacrificing quality,” says Hopgood. “We advise, but we don’t dictate. Finally, our long history and experience in the market mean that we have significant experience to underpin our strategy. The combination of these things enables us to remain at the forefront of innovation but to ensure compliance for our customers and its this that makes us a trusted provider.”

In conclusion, the evolution of IRT from touch-tone telephone systems to advanced cloud-native SaaS solutions has made it a mission-critical component in modern clinical trials. Initially developed to address manual randomisation and drug supply management challenges, IRT now integrates with other eClinical solutions to enhance efficiency and data integrity. Driven by its ability to predict trial supply needs and reduce costs, Perceptive eClinical, the industry’s first RTSM provider, continues to lead with its adaptable, quality-focused approach, ensuring compliance and innovation in the field.