IRT Master Protocol

Flexible Solution to Support New and Complex Trial Designs

Master protocol studies require technological tools that are highly flexible because these complex studies need to be designed to support multiple therapies across multiple indications, mid-study amendments, multiple patient populations, several supply strategies, and sometimes in partnership with multiple sponsors. YPrime’s highly flexible IRT platform supports multiple protocols, patient populations, and supply strategies.

YPrime’s IRT solution is a highly configurable platform that supports the randomization and clinical supply management needs of these complex basket, umbrella, and platform trials. We make it easy to manage cohorts, add new treatment arms, allocate or add drug supplies across multiple trials, and dynamically manage functionality to support these study types.

Patient Workflow

With YPrime’s IRT, you can create patient workflows that are specific to your protocol requirements such as:

  • Flexible visit structures, dispensation needs or subject management
  • Multiple visit tracks per protocol, or per patient
  • Our comprehensive oncology suite includes modules such as re-treatment, re-screening, cycle-based visit, Progression Free Survival Visit or dose adjustment
  • Seamless handling of multi-part or run-on studies

Randomization

YPrime’s IRT Platform provides an agile and configurable framework to implement advanced randomization schemes such as central, blocked, stratified, minimization, and randomization with cohorts.

Self-Service Clinical Supply Management

YPrime’s IRT platform features full self-service functionality to manage supply strategies, material release, depots and more – without waiting on helpdesk or project management staff.

  • Adjust supply strategy as needed
  • Cohort-specific resupply