A New Approach To Meeting The Needs Of Early Phase Trials With IRT

By Nikki Pfammatter, Director, Project Management, IQVIA IRT

Early phase clinical trials have a unique set of challenges: tight budgets, compressed timelines, and complex operations despite their small size. Randomization and trial supply management (RTSM) technology has traditionally been seen as too expensive and rigid for the needs of early phase trials.

Because Phase 1 trials typically have a small number of participants and limited budgets, study teams often rely on manual spreadsheets to manage RTSM. This approach avoids the time and cost of setting up a traditional Interactive Response Technology (IRT) system.

However, as early phase studies become more complex—especially in fields like oncology, cell and gene therapy, and rare diseases—manual systems are no longer sufficient. Sponsors need to rapidly adjust cohorts, treatment arms, visit schedules, and dosages. Managing these variables with spreadsheets places a heavy burden on study teams and increases the risk of errors.

As a result, sponsors are now reconsidering the role of IRT in early phase trials, yet not all technology providers can offer the required flexibility. Access the full article to see how IQVIA IRT is being deployed to offer greater control, ease of use, and cost efficiencies compared to manual processes.