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The Value of IRT expertise

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

Every study supported by Calyx IRT includes a dedicated Statistical Design & Trial Supplies Consultant with an average of 7 years experience. This group of highly experienced consultants 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.

ENGAGE WITH A CALYX RANDOMIZATION EXPERT
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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? 没问题。

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

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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:

  • Demand planning and 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 code look-ahead
  2. Fractional prediction
  3. Automated scheme switch

与我们的专家讨论

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

Arrange a meeting with a Calyx Technical Consultant today.

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Vice President, Scientific E-tech Enabled Services

Craig Mooney

Craig Mooney has nearly 30 years experience in the clinical development industry, with a concentrated focus on optimizing IRT to improve clinical trial efficiencies. Craig brings a unique understanding of IRT from both a delivery and user perspective, having served as the Director of IRT at Bristol-Myers Squibb for most of the past decade and having held roles in clinical operations, IMP packaging, and labeling & logistics. He is considered an industry expert and has been a featured speaker at numerous IRT conferences including positions as Conference Chairman.

 

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Director, Technical Solutions

Sylvain Berthelot

Sylvain has acquired extensive experience in IRT through various roles within Calyx over his 10+ years in the company. It allows him to grasp where IRT can make a difference based on the protocol design, and accordingly advise clinical trial teams what solution is the most suitable for each trial. Sylvain is a key member of the Calyx IRT product core team, acting as an advocate for end-users, as well as sharing his vision with the team to push the boundaries of IRT.

 

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Associate Director, Statistics & Product Support Services

Malcolm Morrissey, PhD

Malcolm is responsible for a team of consultants who contribute to the design, review, and technical live study support for all Calyx IRT studies. He holds a PhD in Statistical Inference, obtained in 2001, and has 20 years of pharmaceutical industry experience. His key interest areas are randomization design and medication management in IRT. Malcolm and his team are subject matter experts in these areas for Calyx and their experience is shared in conferences, publications, and, crucially, in client-facing meetings at any point in the life cycle of a Calyx-supported trial.

 

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Associate Director, Project & Program Management

Lee Bardy

Lee provides extensive knowledge and oversight in clinical trials in the IRT space. She has designed complex and adaptive RTSM system designs to meet a wide range of needs required in therapeutic areas ranging from oncology and neurology to infectious diseases, and many more. With over 12 years’ experience in the pharmaceutical industry, she is viewed as a subject matter expert, reviewing and advising on protocol design and new product innovation and implementation. She manages a team of Business Analysts who ensure Calyx IRT systems are built with efficiency, data integrity, and patient safety in mind.
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Statistical Design & Trial Supplies Consultant

Steve Siron

Steve is a member of a team of consultants who contribute to the design, review, and technical live study support for all Calyx IRT studies. He holds a BSc in Pharmacy and has 20 years of IRT experience. Steve is one of the subject matter experts in randomization design and medication management in IRT for Calyx. Prior to joining his current team, Steve functioned as an IRT Project Manager, Solutions Designer, and Production Programmer, giving him a complete background in Calyx IRT system functionality.

 

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Arrange a meeting with a Calyx Technical Consultant today.

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