Flexible Designs and Randomization

Complex Studies

Planning a platform, basket or umbrella trial?  These complex protocols expand clinical trial participation by allowing more patients to have accelerated access to treatment therapies but require a host of upfront planning considerations. YPrime’s IRT platform supports adaptive and master protocol designs with configurability, drug pooling strategies and program-based supply management. 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 Workflows

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

  • Unique 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

YPrime’s IRT eliminates the outdated practices of aligning your processes with your IRT system, instead of the other way around.

Phase I Solutions: Early Phase IRT

Our enterprise solutions for early phase studies have all the reliability of full-featured systems, without the expense. Our platform provides a simplified design, specifically built for Phase I-II needs, including:

  • Dynamic ability to add new cohorts as the trial expands
  • Multiple cohorts with different dosing strategies for each
  • Investigator selected cohorts or system randomization into cohorts
  • Patient replacement within a cohort
  • Drug management that supports global phase 1 studies


YPrime’s IRT platform supports randomization schemes from single and multiple strata combinations to unique and one-of-a-kind designs. Our considerable experience spans hundreds of trials and dozens of countries.

Our flexible framework allows biostatisticians and developers to implement complex randomizations that meet protocol requirements including concepts such as

  • central randomization
  • blocked randomization
  • stratified randomization
  • minimization (Pocock and Simon)
  • and randomization with cohorts

Biostatistical expertise goes hand-in-hand with successful IRT implementations. That’s why our in-house biostatisticians are always available for strategic guidance or support as needed.

Knowledgeable IRT project managers can help study teams avoid bias and other common pitfalls around randomization errors throughout a trial.

Bring us your most complex algorithmic re-randomization design and rely on our powerful and nimble IRT technology to support your clinical trials and programs.

Minimize your clinical trial risk with YPrime’s IRT solutions.

Contact Us