Case Study

 

Phase I IRT System Delivery in Days, not Weeks

Sometimes the biggest efficiency gains are not achieved through major innovations, but from practical applications of existing technology. What began as an IRT system to support a sponsor’s early phase study requirements ended up as an enterprise platform for all Phase I studies.

Although Phase I requirements are narrower in scope than Phase II-III studies, the demands are often no less onerous. When a biopharmaceutical company asked YPrime to build a custom IRT system, they did not need robust functionality or expense of a system build designed to support Phase II and III studies. They wanted a solution to help manage complex stratification, site activity management and patient management for early phase oncology studies. As a quality assurance imperative, it was necessary to replace manual randomization efforts with a validated system.

Soon into development, both teams recognized the value of broadening the project scope to manage the needs of multiple studies. YPrime built a platform that offered flexibility to support the diverse requirements of the company’s multi-program Phase I studies, and provided the ability to make changes after system go-live. These configurable components minimize the need for additional programming and validation.

The result? A simplified, yet powerful IRT enterprise solution capable of handling:

  • Drug supply
  • Weight-based dosing
  • Study visits
  • Cohort management
  • Titration

Providing the most utility to the client was the ability to better manage dosing scenarios, visit schedules and drug supply for complex oncology studies. This is no small task considering the growing number of studies that now involve multiple treatment arms, four to five cohorts and nearly limitless dosing possibilities. YPrime’s IRT can map each patient to a visit and study medication schedule, and offers flexible clinical supplies management capabilities.

In addition, clinical teams have control over the cohort management with functionality that includes:

  • Naming or re-naming
  • Open and closing a cohort
  • Changing the number of subjects allowed per cohort
  • Managing patient replacement per cohort
  • Defining dispensing per cohort

A cost-effective IRT platform, paired with sound project management and a robust set of standards now allows the sponsor to implement Phase I studies in one week, with easy traceability of study medication.

In clinical development, everyone tries to offer solutions for early phase studies, but virtually no one succeeds. YPrime has earned a reputation for simplifying the tools to support clinical research through our consultative, hands-on approach. We have resources and experience to help solve your biggest clinical data challenges.