IRT and RTSM systems attract investment as adoption grows among CROs and sponsors

Interactive response technologies (IRT) and randomization and trial supply management (RTSM) systems are now a critical part of the clinical trial ecosystem, and investors have recognized the opportunity.

According to Andrew Rohrbaugh, vice president of strategy at Veeva RTSM, who told Clinical Insider, “Like most other eClinical products, the RTSM space is ever evolving, more recently driven heavily by venture capital and private equity investment.

“The space has become commoditized; however, new providers usually try different approaches to solve existing challenges. When successful, existing providers typically become fast followers, adopting new features or approaches to remain competitive,” he said.

But irrespective of the changing financial landscape, for sponsors and CROs, the rationale for using an IRT or RTSM system — reducing the risk of errors —– has not changed since the earliest iterations of these technologies, according to Rohrbaugh.

“An RTSM system holds the randomization list used to assign a treatment to a given patient or subject. In double-blind trials, the patient, site personnel, and even sponsor and CRO teams cannot know what treatment was assigned. The RTSM system allows the assignment to occur while protecting the blind requirement.

“The drug, or other investigational product, is similarly blinded with only a kit number used to identify it. RTSM also holds the material list that links specific kit numbers to the material types, dose levels, and other information so that it can determine which kits should be assigned to which patient,” he told us.

Also, because most staff working on a given study are not allowed to interact with or view data, sponsors and CROs use RTSM systems — which typically feature role-based controls — to ensure blinding is protected, Rohrbaugh noted

Future trends

Looking forward, Rohrbaugh expects systems to continue evolving and incorporating new capabilities and technologies. However, at present, the role AI will play is unclear.

“Due to the risk involved, it is unlikely that AI will be directly used in randomization, and at least initially, in the day-to-day trial supply for clinical sites. That said, it could be a powerful tool for drug supply forecasting at a larger scale, identifying risks and recommending changes in the overall supply chain for an individual study or program of studies.

Rohrbaugh added, “I see the development of AI agents for RTSM as beneficial, especially when targeting specific areas of efficiency or tasks that are more difficult to complete manually, such as identifying trends in data changes, helpdesk requests, or audit trails.”

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