Technical Expertise


Technical Consulting

The Value of IRT expertise

When you work with Calyx IRT, you immediately have access to some of the industry’s most experienced randomization and trial supply management professionals.

Every study supported by Calyx IRT includes a dedicated expert with an average of 8 years experience. This group of dedicated experts extend their expertise to you, providing direction on all aspects of randomization, medication management (including dispensing and supplying sites/depots), and calculations to support eligibility, dosing, and titration – all of which drives your trial’s success.


Calyx randomization expertise

Unsure how to balance treatment arms by trial end?  We can help. Need something other than a straight-forward blocked randomization list? We got this Not sure where to start on a master protocol? No problem.

Engage directly with Calyx randomization experts during protocol design, trial setup, and trial execution.

Their expertise, which stems from having designed thousands of IRT solutions includes:

  • Blocked randomization with or without stratifying factors, where blocks are allocated on-demand, pre-allocated, or using a mixed allocation
  • Minimization with biased coin allocation
  • Dynamic Hierarchical Randomization Allocation (DHRA)
  • Zelen’s method
  • Master protocols (encompassing Basket, Umbrella and Platform trials)
  • Bayesian adaptations
  • Adaptive trial designs, including adaptive cohorts
  • Conditional patient replacement


Calyx trial supply management expertise

Calyx IRT includes valuables services delivered by trial supply management experts who understand your trial needs and constraints and can recommend how to avoid supply chain disruptions and reduce the overall cost of drug supply management.

Their expertise comes from managing protocol designs that have addressed hundreds of complex clinical supply situations that occur expectedly, and unexpectedly during trial execution.

Calyx IRT supply management experts can provide direction on:

  • Supply forecasting
  • Minimizing the risk of supply chain disruption
  • Complex dispensing situations, such as partial allocation or pack type substitution
  • Pooling medication across trials, within a master protocol or simply across a program of studies
  • Automating the calculation of dosing or titration
  • Multi-stage logic to determine patient attributes, such as dose, stopping rules, or any shamming/mock algorithms
  • Reducing drug wastage to the minimum, through advanced IRT supply management algorithms:
  1. Randomization prediction
  2. Fractional prediction
  3. Automated supply strategy management

Meet the Experts

Extend the deep and diverse experience of Calyx’s highly tenured technical experts to your own technical team.

Meet the experts.

Extend the deep and diverse experience of Calyx’s highly tenured medical, scientific, and regulatory experts to your own clinical development team.