Effective Randomization

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Effective Randomization

With a dedicated statistics team tasked specifically with implementing randomization and medication management algorithms, Calyx IRT is one of the most advanced solutions for clinical trial randomization. And, since every study is supported from initial design to closure by a dedicated IRT and randomization specialist with at least eight years of experience, it’s no wonder why clinical trial sponsors have relied on Calyx IRT in over 4,600 trials to date.

Calyx’s wide range of fully validated randomization algorithms are configured to meet the needs of each individual study, and our proven IRT platform can be customized to any randomization algorithm, no matter how complex.

It takes more than technology to ensure effective randomization. Contact us to learn how Calyx’s robust system and the experts behind it can make a difference in your clinical trial.

Randomization Methodologies

From the Simple to the Complex

Calyx regularly supports studies that include adaptive designs, such as where the optimal dosing method is not known at the start of the trial, or where treatment arms may be dropped or added during trial execution. Calyx can include a variety of adaptive designs if the possibilities are known in advance, giving the sponsor control over what changes are made, and when, during the trial.

Calyx has provided technology solutions for many of the more complex trials, including:

Bayesian response adaptive designs
Parallel group designs, where arms are dropped and added and where the allocation ratio changes
Cohort-specific randomization, with adaptive dosing, time interval constraints, and patient replacement in a cohort
Adaptive platform designs with multiple sub-protocols, where treatment arms can be dropped within specific sub-protocols at interim analysis

Randomization Lists

Calyx follows detailed and secure processes for the generation, QC, storage, review, and approval of randomization lists, using an in-house validated tool that has been used on over 3,000 trials. The parameters of the randomization list are defined together with your statistician, with support from our statistical designers whose experience in this area is unmatched.