RFP

Clinical Trial Solutions

Interactive Response Technology (IRT)

Calyx’s extensive experience and award-winning IRT system optimizes randomization and clinical trial supply management (RTSM) processes to propel your development program forward.

Clinical Trial Solutions

Interactive Response Technology (IRT)

Calyx’s extensive experience and award-winning IRT system optimizes randomization and clinical trial supply management (RTSM) processes to propel your development program forward.

Right treatment. Right patient. Right time.

Calyx IRT is a robust Randomization and Trial Supply Management (RTSM) solution, proven across 4,500+ studies to reduce risks and optimize suppliesensuring trial sponsors and CROs meet key milestones through reliable, and flexible, on-time medication delivery.

Gain access to some of the industry’s most experienced IRT professionals and a solution that has evolved over nearly 30 years to meet the continuous challenges facing the pharmaceutical industry.

Calyx IRT. A solution you can trust. Every time.

 

Right treatment. Right patient. Right time.

Calyx IRT is a robust Randomization and Trial Supply Management (RTSM) solution, proven across 4,500+ studies to reduce risks and optimize suppliesensuring trial sponsors and CROs meet key milestones through reliable, and flexible, on-time medication delivery.

Gain access to some of the industry’s most experienced IRT professionals and a solution that has evolved over nearly 30 years to meet the continuous challenges facing the pharmaceutical industry.

Calyx IRT. A solution you can trust. Every time.

JOIN THE NEXT EVENT

Get answers to your questions about Calyx IRT and gain the confidence you need to drive your trial’s success!

Discover the Calyx IRT Difference

With Calyx’s proven processes, you spend less time on IRT considerations and more time on trial execution. From initiating the IRT design to database lock, Calyx’s expert project teams recommend the best functionalities to meet your protocol requirements, increase RTSM efficiencies, and adapt to unplanned situations.

irt system benefits section

Discover the Calyx IRT Difference

irt system benefits section

With Calyx’s proven processes, you spend less time on IRT considerations and more time on trial execution. From initiating the IRT design to database lock, Calyx’s expert project teams recommend the best functionalities to meet your protocol requirements, increase RTSM efficiencies, and adapt to unplanned situations.

Simplifying the complex

Built on decades of experience and designed by the most experienced project teams in the industry, Calyx IRT simplifies the complications involved with RTSM. From simple blocked and stratified designs to more complex adaptive trial designs, Calyx IRT delivers advanced randomization and trial management suitable for all trials.

Adaptable functionality

A 4,500+ trial-tested system, Calyx IRT uses automated workflows, self-service tools, and reporting to meet the unique needs of each trial and each system user. Take advantage of flexible, robust medication management algorithms, simplified study and site management, and protocol-tailored patient management, including Direct-to-Patient shipments with Calyx IRT.

Seamless Integrations

By integrating Calyx IRT with other eClinical systems, sponsors boost productivity and improve data quality, reducing the need for data duplication and reconciliation at the end of the trial. Calyx enables everything from simple IRT-to-EDC integrations to more complex, blinded central lab integrations and electronic patient reported outcome (ePRO) scoring.

Accelerated study start-up

Need to start a trial quickly? By taking advantage of pre-defined standards, Calyx can deliver a reliable IRT system for User Acceptance Testing only 4 weeks after specification sign-off. Calyx’s experienced team will recommend the optimal IRT design for you based on their wealth of experience building and supporting trials.

Improve data quality

Calyx IRT minimizes data errors through real-time data entry validation, reduces the need for data duplication through flexible integrations, and reduces ambiguity during data capture by guiding sites on how and when to enter patient data in alignment with the protocol. And Calyx IRT is configured to reduce the risk of unblinding, randomization imbalance, or mis-dispensing, resulting in increased protocol compliance and high data quality.

Reduce drug wastage

With advanced inventory management algorithms that automatically direct supply to recruiting sites’ needs, and specific trial- and program-level waste reduction strategies, Calyx IRT can help balance the costs of drug production and shipment, reducing the amount of drug wasted during clinical trials and minimizing your organization’s carbon footprint.

Simplifying the complex

Built on decades of experience and designed by the most experienced project teams in the industry, Calyx IRT simplifies the complications involved with RTSM. From simple blocked and stratified designs to more complex adaptive trial designs, Calyx IRT delivers advanced randomization and trial management suitable for all trials.

Adaptable functionality

A 4,500+ trial-tested system, Calyx IRT uses automated workflows, self-service tools, and reporting to meet the unique needs of each trial and each system user. Take advantage of flexible, robust medication management algorithms, simplified study and site management, and protocol-tailored patient management, including Direct-to-Patient shipments with Calyx IRT.

Accelerated study start-up

Need to start a trial quickly? By taking advantage of pre-defined standards, Calyx can deliver a reliable IRT system for User Acceptance Testing only 4 weeks after specification sign-off. Calyx’s experienced team will recommend the optimal IRT design for you based on their wealth of experience building and supporting trials.

Improve data quality

Calyx IRT minimizes data errors through real-time data entry validation, reduces the need for data duplication through flexible integrations, and reduces ambiguity during data capture by guiding sites on how and when to enter patient data in alignment with the protocol. And Calyx IRT is configured to reduce the risk of unblinding, randomization imbalance, or mis-dispensing, resulting in increased protocol compliance and high data quality.

Seamless Integrations

By integrating Calyx IRT with other eClinical systems, sponsors boost productivity and improve data quality, reducing the need for data duplication and reconciliation at the end of the trial. Calyx enables everything from simple IRT-to-EDC integrations to more complex, blinded central lab integrations and electronic patient reported outcome (ePRO) scoring.

Reduce drug wastage

With advanced inventory management algorithms that automatically direct supply to recruiting sites’ needs, and specific trial- and program-level waste reduction strategies, Calyx IRT can help balance the costs of drug production and shipment, reducing the amount of drug wasted during clinical trials and minimizing your organization’s carbon footprint.

Effective RTSM, backed by proven experience.

Getting randomization right and getting supplies to sites on-time can be a risky business. Trust Calyx IRT – and the decades of experience behind it – to reduce RTSM risks and help your trial succeed.

4.5K+
TRIALS
2.6M+
PATIENTS
500
APPROVALS
SUPPORTED
250+
ADAPTIVE
TRIALS
4.5K+
TRIALS
2.6M+
PATIENTS
500
APPROVALS
SUPPORTED
250+
ADAPTIVE
TRIALS

Expertise matters.

Successfully used in over 4,500 studies and having supported over 500 regulatory approvals to date, Calyx is proven to deliver reliable and effective RTSM. For all therapeutic areas. For all phases. For all trial designs.

Calyx IRT experience over the past 5 years

Experience by Therapeutic Areas
irt system expereience by therapeautic areas graph

Advanced Features Drive Trial Success

The technical experts behind Calyx IRT understand the randomization and trial supply issues that can impact the success of clinical trials. Based on decades of experience delivering effective and efficient RTSM, the following advanced features are available to help clinical trials succeed:

irt system aligning point

Enhanced Self-service Tools

Calyx IRT puts the power back into the hands of trial sponsors and system users, with access to real-time data and the ability to make immediate changes as needed. This includes everything from simple changes such as an investigator correcting a patient’s date of birth, closing screening, or increasing enrolment caps at any level to the complex, such as immediately adding new doses for new cohorts of patients, adding new countries to accelerate recruitment, or closing treatment arms following a safety review.

irt system aligning point

Advanced Inventory Management Algorithms:

Automated Supply Strategy Management takes the burden of monitoring site stock away from the clinical supply manager by automatically adapting the amount of medication shipped to sites based on the number of patients in screening.  As a result, patients at recruiting sites are assured drug supply, while drug wastage and the risk of failed visits are reduced.

Medication Pooling reduces drug wastage and addresses drug availability concerns by sharing medication across different protocols in a single program. Calyx IRT controls the sharing of medication across protocols and facilitates just-in-time labeling, drawing on a wealth of experience supporting a range of different sponsor pooling methods and labeling plans.

Randomization Prediction When randomization codes are dedicated to the site, Calyx IRT can reduce drug wastage by sending IMP to each site specific to upcoming treatment group assignments.

irt system aligning point

Calyx applies advanced IRT algorithms to address the unique challenges of cell and gene preservation during these complicated clinical trials.

irt system aligning point

Task Manager

Calyx IRT task manager functionality improves efficiencies by presenting a summary of patient visits that, according to the protocol, need to be registered within the next 24 hours and enables site personnel to quickly see which visits are due in the coming week/s. By elevating this important information, Calyx IRT Task Manager saves valuable time for busy site personnel and makes it easier for them to meet protocol requirements.

IRT System Consulting

Calyx IRT experts bring a collective 100 years’ experience in applying advanced technology to optimize RTSM, enabling Calyx customers to run effective and efficient clinical trials.

Whether your trial is simple or complex, local or global, with 50 patients or 5,000, gain access to some of the industry’s most experienced IRT professionals to help you get the most out of your IRT system and drive your trials’ success.

IRT System Consulting

Calyx IRT experts bring a collective 100 years’ experience in applying advanced technology to optimize RTSM, enabling Calyx customers to run effective and efficient clinical trials.

Whether your trial is simple or complex, local or global, with 50 patients or 5,000, gain access to some of the industry’s most experienced IRT professionals to help you get the most out of your IRT system and drive your trials’ success.

Library

Discover the Calyx Difference with Calyx IRT

Gain confidence in RTSM through Calyx IRT, an extremely robust system built on decades of experience and delivered by the most experienced project teams in the industry.
Read more

Increase Efficiencies through Effective IRT Partnering

How can a program management approach combined with IRT standards overcome obstacles, alleviate RTSM-related pressures, and allow study teams to focus on other clinical development needs? Read the Case Study.
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Optimizing Supplies with Calyx IRT: Ensure Patient Supply while Limiting Buffer

Calyx IRT provides a complete, integrated solution for managing and optimizing supplies. Learn about Calyx RTSM expertise.
Read more

Reducing Overage with Calyx IRT: Minimize Monitoring Burden while Optimizing Supplies

Calyx IRT provides a complete, integrated solution for managing and optimizing supplies. Learn about Calyx RTSM expertise.
Read more