Calyx advanced inventory management strategies can reduce clinical trial drug wastage by up to 50%

Nottingham, England and Morrisville, NC – November 22, 2022 Calyx, the eClinical and Regulatory solutions and services provider relied on for solving complex data challenges in clinical research, announced today that a Top 10 pharmaceutical company is leveraging medication pooling, an advanced inventory management strategy available through Calyx IRT (interactive response technology), to improve drug distribution efficiencies and reduce drug wastage in an ongoing, global clinical development program.

The Top 10 pharma company is benefitting from Calyx’s proven solution which supports medication pooling and just-in-time labelling across multiple studies in their program. Calyx IRT medication pooling enables study drug to be shared across multiple protocols, enabling trial sponsors to reduce the impact of excessive drug wastage typically incurred during drug development.

“In addition to reducing drug wastage, medication pooling delivers an effective solution for addressing scarcity concerns and other restrictions which affect the supply of medication during clinical trials,” said Malcolm Morrissey, Head of Statistical Design and Trial Supplies at Calyx.

Medication pooling is possible when a suite of studies or programs use the same medication. The Top 10 pharma company implemented IRT medication pooling for a suite of five studies involving nearly 500 sites using 20 depots across 30 countries. In the first year of the program, Calyx has managed 1.5 million packs of a dozen medication types.

This latest innovation around pooled medication has already been deployed in 80 trials to date across North America, Europe, and Asia. IRT medication pooling is one of Calyx’s many advanced inventory management strategies that could help trial sponsors reduce drug wastage by up to 50%.

Click here for more information on how Calyx IRT self-service tools and other advanced functionality drives clinical trial success.

About Calyx

Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. With deep expertise in clinical development and 30 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day.

Medical Imaging | IRT | CTMS | EDC | RIM

Take your trials further with intelligent insights at Calyx.ai or at LinkedIn, Twitter, or Facebook.

Contact:

Christine Tobin | [email protected] | +1 412-628-8598

Intelligent functionality removes supply team burdens while ensuring drug availability and reducing waste

Nottingham, England and Morrisville, NC – November 7, 2022 Calyx, the eClinical and Regulatory solutions and services provider relied on for solving complex data challenges in clinical research, today announced an enhancement to its interactive response technology (IRT) system. By removing the supply monitoring burden from clinical trial teams, Calyx IRT’s automated supply strategy management reduces the cost of drug waste while ensuring study drug is available at investigative sites on time, every time.

Traditional IRT solutions require trial teams to constantly monitor patient recruitment levels and the unpredictable supply needs that arise during clinical trials, including randomization and damaged stock replacement. When trial teams don’t take the burdensome, manual steps to address changing site needs, high-enrolling sites risk stock-outs and failed patient visits, and low-enrolling sites end up with more supplies than needed, resulting in unnecessary drug waste.

“The act of consistently balancing appropriate site-level inventory without incurring excessive drug waste is difficult and time-consuming for most trial supply teams,” said Juan Munoz Pujol, Vice President of IRT at Calyx. “In addition to having confidence that Calyx IRT will get the right drug to the right patient at the right time, trial supply teams can now leverage automated supply strategy management to remove the burden of monitoring site stock against a site’s IRT settings and keep drug waste at a minimum. We are already seeing significant savings on clinical development budgets, especially in oncology trials and in other therapeutic areas where the expense of drug production is very high.”

Calyx’s automated supply strategy management is beneficial in numerous trial design scenarios and is particularly useful at reducing the burden on the clinical supply manager when a trial requires a large number of sites in order to meet patient enrolment goals.

Click here for more information on how Calyx IRT automated supply strategy management and other advanced functionalities drive clinical trial success.

About Calyx

Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. With deep expertise in clinical development and 30 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day.

Medical Imaging | IRT | CTMS | EDC | RIM

Take your trials further with intelligent insights at Calyx.ai or at LinkedIn, Twitter, or Facebook.

Contact:

Christine Tobin | [email protected] | +1 412-628-8598

Advanced IRT system enhanced with self-service functionality to quickly address trial challenges

Nottingham, England and Morrisville, NC – October 24, 2022 Calyx, the eClinical and Regulatory solutions and services provider relied on for solving complex data challenges in clinical research, today announced a significant enhancement to its advanced interactive response technology (IRT) system. Calyx has expanded its self-service IRT tools, which enable clinical trial sponsors and CROs to quickly adapt to trial needs without reprogramming.

With the ability to easily add countries and depots to Calyx IRT’s customizable platform, sponsors can react to the inevitable changing needs of their trials and quickly have medication available for patient enrolments at new sites worldwide.

“Facing tighter than ever timelines, most sponsors expand their trials to additional countries at least once, if not multiple times during clinical trials in order to meet patient recruitment goals,” said Juan Munoz Pujol, Vice President of IRT at Calyx. “This new functionality gives sponsors the flexibility they need to easily change their core IRT settings as often as circumstances require to quickly activate sites in new countries and accelerate patient recruitment. We believe this benefit will be reflected in faster timelines and lower costs.”

Click here for more information on how Calyx IRT self-service tools and other advanced functionality drives clinical trial success.

About Calyx

Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. With deep expertise in clinical development and 30 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day.

Medical Imaging | IRT | CTMS | EDC | RIM

Take your trials further with intelligent insights at Calyx.ai or at LinkedIn, Twitter, or Facebook.

Contact:

Christine Tobin | [email protected] | +1 412-628-8598

Calyx IRT includes one of the most (if not the most) flexible inventory management modules in the industry. We leverage this flexibility and our expertise in clinical supplies management to design inventory solutions that truly help sponsors reduce their drug management budget while ensuring adequate patient supply.

The key is to stop relying on buffer stocks.

Trial supply solutions typically rely on a minimum stock of medication sent to each site upon activation. This medication may or may not be used, depending on how many patients the site recruits. It is not unusual to waste a large part of the medication stored at site, in cases where site recruitment doesn’t meet expectations.

Sponsors could save an average of 15-25% of the medication typically wasted by using Calyx’s automated supply strategy management.”

– Sylvain Berthelot, Sr. Director, Voice of Customer & Strategy, Calyx

Automated supply strategies

One of Calyx IRT’s advanced inventory management options is automated supply strategy management.

Calyx’s automated supply strategy management option automates how many drug kits are shipped to sites. Instead of shipping a set amount of medication to each site based on expected recruitment rate, Calyx IRT ships medication only to sites that recruit, based on the number of patients actively in screening. As a result, there is no medication wasted at sites that do not recruit, and there is less risk of wasting medication at sites that under-recruit.

With this type of automation, Calyx IRT adapts the amount of medication shipped to sites to the number of patients in screening. You do not use low, medium, and high supply strategies anymore, the IRT system automatically adapts the strategy to each site’s individual needs.

The proof is in the numbers (not the pudding, I ate it… sorry)

It is not always easy to tell how much medication you have saved on a study, as most sponsors don’t actually measure the amount of medication wasted. However, with simulation tools, you can estimate the savings between the two different supply methods. With automated supply strategies, we expect that sponsors could save 15-25% of their medication on average. Trial-specific conditions may impact this number, but it will definitely lead to savings in the number of kits wasted.

If you would like to know how much you can save on your next trial, we can run a simulation for you.

Reduce waste, reduce effort, save money

Supply strategy automation is a tool that all clinical supply managers need to optimize their supply management budget. You will spend less time monitoring actual site recruitment. You won’t need to change supply strategies depending on actual recruitment rates. Your shipments to sites will be fully automated and will result in less drug wasted. Patients are still assured adequate supply and the risk of failed visits is reduced.

Talk to one of our experts to learn more how you can apply it to your trial.

We started this series by establishing the difference between partial and full unblinding and later, reviewed the trigger points that may result in unintentional unblinding during various trial scenarios.  Here we take a different approach and present additional factors, some of which might be considered controversial. related to unintentional and partial unblinding in clinical trials.

Unblinding prevention is a popular topic in the IRT space. It’s well accepted that an accidental unblinding can have ramifications for the study data as well as for individual patients. However, there are specific aspects related to unblinding that aren’t as universally agreed upon.

At Calyx, we discuss the risks of unblinding with our customers often. I would say further that as a provider of IRT services we have probably seen more risks for unblinding than our customers. And what I can tell you from these many discussions is that what unblinding is – and what it is not – is not a closed issue.

Having worked in the IRT space for 25 years, I have a broad understanding and have heard a broad range of perspectives on the topic, particularly as it relates to “partial unblinding”.

There are absolutes on what unblinding is, but there are certain aspects that are open for debate and interpretation.”

– Craig Mooney, VP Scientific eTech-Enabled Services, Calyx

From participating in debates as both a clinical trial sponsor (with internal customers) and as a solutions provider, I can tell you there is not universal agreement on the following edge issues:

Is partial unblinding a real concern or an overreaction? Is there data to suggest it has a real-world impact or is it just a perception?

Is there a difference between knowing the treatment assignment of an individual subject vs a group of subjects in an open label study? Does aggregate data lead to the same bias in an open label study as it would in a blinded study?

What about random allocation of supplies vs a predetermined dispensing sequence? Can we protect the blind better through this process?

Are randomly generated container / kit numbers an added safety net for unblinding or are they a site burden?

What are the perspectives on not assigning a kit (post-randomization) if not all material types are available? This one is particularly divisive, and I have seen both positions argued aggressively and with conviction of absolute certainty.

Hear from the expert!  In this webinar, Calyx’s Malcolm Morrisey presents “Unintentional Unblinding: Don’t Miss Hidden Risks.”

View Recording!

There are absolutes on what unblinding is, such as revealing the treatment assignment on a confirmation intended for blinded staff. But there are certain aspects that are a little less clear and open for debate and interpretation.

As our approaches to randomization and trial supply management continue to advance, it’s becoming more important than ever that we begin these conversations to ensure the integrity of blinded clinical trials.

Click here to learn how Calyx’s proven IRT system can minimize the risk of unintentional unblinding in your clinical trial.

Minimizing the risk of unblinding during clinical trials is of paramount importance. Clinical trial sponsors, monitors, investigative site personnel and all others involved have a responsibility to ensure that unintentional unblinding does not occur.

In an earlier blog we established the difference between partial and full unblinding. Here we review the trial trigger points that may result in unintentional unblinding including scenarios during randomization, dispensing, shipping, site supply, drug accountability, and study management.

It’s important to work with a reliable IRT provider who understands your study needs and will design a system to mitigate the risk of unintentional unblinding at every stage.”

– Malcolm Morrissey, Assoc. Director, Statistics, Calyx

Hear from the expert!  In this webinar, Calyx’s Malcolm Morrisey presents “Unintentional Unblinding: Don’t Miss Hidden Risks.”

View Recording!

Randomization

  • Reporting randomization number when blocks are dynamically allocated to strata (with a higher risk with site stratification)
  • Reporting randomization number when forced randomization is permitted (with a higher risk with site stratification & if there are only 2 treatment arms)
  • What IMP the IRT system checks is available at site before randomization is permitted to proceed (the risk depends on the number of treatment arms & also whether forcing is permitted)
  • Replacing patients at the end of the cohort
  • Reporting randomization number when patients are being replaced
  • If re-randomization is required for a sub-set of treatment arms

Dispensing

  • What IMP the IRT system checks is available at site before medication assignment is permitted to proceed (the risk depends on the number of treatment arms)
  • Selecting which kits should be dispensed to patients
  • When dispensing only a partial amount of required treatment (which could be allowed if the patient can be given sufficient medication until the remainder can be provided)
  • When blinded medication is used in an open label manner (i.e., single blind run-in)
  • When the dose level is known to Investigators, but the treatment is not
  • When one or more treatments are supplied by the site (i.e., the IRT only manages the ‘active’ kit, with the placebo supplied by site: local & central sourcing)
  • If third party lab data is required to make a patient treatment decision (see figure)

Shipping

  • Selecting which kits should be included in shipments
  • If a partial shipment is sent to a site due to a stock out at a depot
  • When shipping in boxes, but dispensing individual packs to patients (the risk depends on the number of treatments in a box, whether dispensation is “random” & also whether forcing is permitted)
  • When different expiry dates are used across blinded batches

Site Supply

  • If there are different trigger & resupply values (buffer stock) for different IMP
  • If the initial shipment to the site only contains 1 of each IMP
  • When new doses are added e.g., for an adaptive study
  • If medication is predicted for all possible treatments for re-randomization when not all patients re-randomize
  • If medication is predicted beyond re-randomization for patients who are not re-randomized and not all patients re-randomize
  • When predicting for an open label extension where medication is not the same across treatments & is determined by blinded treatment (see figure)

Drug Accountability

  • If there is variability in returns and/or destruction procedures for each blinded kit type en-route to or at the destruction facility
  • If there are both blinded and unblinded site personnel, and variations in drug accountability process for different blinded kit types at site
  • If expiry date is unblinding

Study Management / Data Changes

  • If the study is open label, but the Study Team are blinded to treatment group
  • If the study is Double blind, but there is open label treatment
  • When there are two treatment groups and patients receive a different number of kits based on their treatment group
  • When the IRT is only managing one treatment group

Click here to learn how Calyx’s proven IRT system can minimize the risk of unintentional unblinding in your clinical trial.

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