IRT ideal for cell and gene therapy studies, according to IQVIA

Interactive response technologies (IRTs) are an ideal fit for cell and gene therapy trials, according to IQVIA, which says sponsors and CROs increasingly view software suppliers as partners.

The health data and research services firm shared its view on IRT last week, arguing in a blog post that such systems are ideal for the unique, highly complex logistical challenges involved in cell and gene therapy (CGT) clinical studies.

“These trials represent a whole new complexity, where every treatment is as unique as the patient receiving it … This complexity is heightened by strict time constraints, and the need for precise temperature control across the supply chain.

“These logistical challenges require innovative solutions, and Interactive Response Technology plays a critical role in tracking and managing complex trial workflows,” the IQVIA team wrote.

Adaptability

The adaptability of modern IRT systems is key, according to the authors, who pointed to their ability to track materials through the supply chain — from apheresis to manufacturing facility and back to patient — as an example.

“As materials move through the manufacturing process, IRT platforms maintain careful oversight of status changes, location tracking, and chain-of-custody documentation. This includes managing the critical transition from collection materials to manufactured treatment, where precision and accuracy are paramount.”

Batch release is another area where IRT systems are critical, according to the IQVIA team, who wrote that “due to the personalized nature of CGT treatments, each batch has its own unique timeline and handling requirements.

“IRT systems can dynamically generate and track expiration dates, ensuring that treatments reach patients within their viable windows.”

Data integrity

Additionally, safeguarding supply chain data in cell and gene therapy trials is critical, according to the IQVIA authors, who noted that IRT technologies provide a way for sponsors and CROs to protect vital information.

“IRT platforms help eliminate common challenges, like manual entry errors or discrepancies between tracking systems. By providing a single source of truth for all trial-related data, these platforms significantly reduce the risk of data reconciliation issues that could compromise trial validity.”

Partnership

The IQVIA team also looked at the changing role of IRT providers in the CGT trial ecosystem, concluding that such organizations are increasingly viewed as partners by the sponsors and CROs they work with.

“The most successful IRT providers have evolved beyond being mere software vendors to become strategic partners in a trial’s success. They bring valuable experience to the table, helping sponsors avoid common pitfalls and design efficient processes that keep regulators happy while minimizing errors.”

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