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2023 brought many healthcare advances and opportunities for life science professionals to stay current on the research, technologies, and processes that are driving change in how new medical treatments are developed and ultimately approved for worldwide use.

So here, in case you missed them, are the most sought-after articles, videos, case studies, and more produced by Calyx scientific, technical, and regulatory experts this year. Each provides direction and perspective on optimizing and accelerating the clinical development and approval of medical treatments.

We hope you find them as insightful and valuable to you now as they were the first time around.

De-risking Medical Imaging in Solid Tumor Trials

During anti-tumor treatment development, imaging modalities, criteria, and regulators’ expectations change frequently. Without the direction of imaging scientists who work day in and day out in clinical trial imaging, it would be difficult, if not impossible to keep track of and react to changes during these critical and often, lengthy trials.

Successful medical imaging in solid tumor trials requires professionals with therapeutic experience, expertise in the modalities required to demonstrate safety and efficacy, and first-hand insight into what global regulators will look for in your submissions.

This blog presents examples of scientific advances and regulatory changes that are currently impacting anti-tumor treatment research, demonstrating the need for an imaging partner who is immersed in the regulations, scientific learnings, and trends that could impact the success of your development program.

READ THE BLOG

Overcoming Oncology RTSM Challenges with Advanced IRT

Sponsors of oncology trials face unique randomization and trial supply management (RTSM) challenges, including:

  • Central vs. local sourcing of standard-of-care treatments
  • Unknown patient treatment duration
  • Impact of rescue medication on study drug expiration
  • High cost of treatments / need to reduce excessive drug wastage

Learn about these and other supply challenges and how a flexible IRT system can reduce errors, ensure patient safety, and meet changing RTSM during lengthy oncology trials in this article by Calyx’s Malcolm Morrissey, published in International Clinical Trials®.

READ THE ARTICLE

Exceeding Timelines for Accelerated Approval: Calyx Medical Imaging

In oncology clinical development, every day matters. Even more so when your compound has been fast-tracked for approval by global regulators.

Which is why so many clinical trial sponsors rely on Calyx Medical Imaging. Calyx’s collaborative approach, ability to meet each sponsor’s unique needs, and expertise in image acquisition and analysis have repeatedly been proven to help clinical development programs succeed.

Like in this example, where Calyx Medical Imaging delivered critical imaging data in advance of deadlines on an already expedited timeline to help a leading pharmaceutical company receive accelerated FDA approval for a Multiple Myeloma treatment.

WATCH THE VIDEO

How IRT Expertise Surfaces – and the Difference it Makes

An IRT system is a critical part of a clinical trial. The implications for failing to get it right can be impactful not only to study goals but to participants as well.

Here, Calyx’s Craig Mooney gives examples of the consequences that can arise if a study’s IRT system isn’t implemented with insight and precise focus on the protocol’s needs and why expertise matters throughout the clinical trial lifecycle.

READ THE BLOG

Calyx RIM Supports Successful FDA eCTD 4.0 Pilot

Calyx RIM has been successfully used by a global market-leading pharmaceutical company in FDA’s eCTD 4.0 implementation pilot program.

Calyx’s regulatory experts worked closely with this leading company and the FDA throughout the pilot and advanced Calyx RIM based on their feedback and lessons learned.

Learn why you can rely on Calyx RIM as you adopt eCTD 4.0 as part of your global regulatory processes.

READ THE ANNOUNCENENT

Neuroimaging in Alzheimer’s Disease Trials

As our understanding of Alzheimer’s Disease (AD) pathophysiology continues to evolve, we’re seeing advanced approaches for assessing treatment effects in clinical development, including AI/machine learning to measure subtle changes that are difficult for the human eye to detect.

Calyx Medical Imaging delivers neuroimaging expertise to help sponsors meet the unique and emerging needs of early to late-phase AD clinical trials. This paper outlines Calyx’s capabilities and experience, which includes confirmation of eligibility and brain safety assessments with rapid turn-around times as well as advanced quantitative analyses for PET and MRI data to help your AD trial succeed.

READ THE PAPER

Mitigate Unblinding Risks with Calyx IRT

Every clinical trial runs the risk of unintentional unblinding. With 30 years of experience designing reliable RTSM solutions and the processes behind it, Calyx IRT is the solution you can rely on to minimize these risks and ensure the integrity of your clinical trial.

The solution design and technical experts behind Calyx IRT have published a variety of papers, webinars, and blogs to demonstrate where and how unblinding can occur and more importantly, how to minimize those risks.

Access Here

Calyx CTMS Select: Scalable for Small/Mid-sized Biopharma and CROs

The features of Calyx CTMS deliver significant benefits for studies of all shapes and sizes. However, not all studies have the same needs.

Enter Calyx CTMS Select, a pre-configured and validated clinical trial management system for small to mid-tier biopharmaceutical companies and CROs who want reliability and global support but don’t require CTMS customization.

Calyx CTMS Select enables SMID organizations to scale as their operations require and includes the rich features required for clinical trial management oversight and monitoring at lower costs than comparable solutions.

READ THE ANNOUNCENENT

Cookie Cutter Solutions don’t Cut it in Clinical Trial Imaging

When medical imaging is used as a clinical trial biomarker, your centralized core lab provider needs therapeutic/modality and operational expertise to help you meet your development objectives, regardless of where you are in the clinical development spectrum.

Here we review how a small biotech captured the imaging data needed to secure funding and advance their early-stage research on a rare neurological disease compound. And, how a top 5 global pharma captured reliable primary efficacy endpoint data in a pivotal phase III study to achieve regulatory approval on a prostate cancer compound. All supported by Calyx Medical Imaging.

READ THE BLOG

Pre-configured, scalable trial management system enables quicker study starts at a lower cost

Nottingham, England and Billerica, MA – November 20, 2023 – Calyx, the eClinical and eRegulatory solutions and services provider relied on for solving complex data challenges in clinical research announces an offering for small and mid-sized (SMID) biopharmaceutical companies and CROs that delivers the reliability and global operational support of a proven Clinical Trial Management System (CTMS) with faster implementation times and at lower costs.

Calyx CTMS Select is a scalable, pre-configured, and validated solution with the rich features required for effective clinical trial management oversight and monitoring. Based on Calyx’s 25+ years of expertise supporting diverse trials, it is perfectly tailored to meet the needs, timelines, and budgets of SMID organizations that don’t require CTMS customization.

“We listened closely to our customers in designing a robust CTMS solution that’s backed by Calyx’s global support team and enables SMID organizations to scale as their operations require,” said Serena Barker, Vice President and General Manager of Enterprise Technology at Calyx. “We’re delighted to extend our expertise on best practices to drive value for these organizations and to deliver a reliable CTMS that enables them to simplify the oversight of their trials at a lower cost than comparable solutions available today.”

Calyx CTMS Select can be implemented in as little as 6-8 weeks and includes out-of-the-box eTMF and EDC integrations and sophisticated features – such as comprehensive site payments – that are rarely included in solutions for smaller organizations.

Click here for more information on Calyx CTMS Select.

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.

CTMS | EDC | IRT | Medical Imaging | RIM

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

Contact:

Christine Tobin | Christine.Tobin@Calyx.ai | +1 412-628-8598

2022 brought many healthcare advances and opportunities for life science professionals to stay up to date on the research, technologies, and processes that are driving change in how new medical treatments are developed and ultimately approved for worldwide use.

So here, in case you missed them, are the most sought-after articles, white papers, webinars, and more produced by Calyx scientific, technical, and regulatory experts this year. Each provides direction and perspective on optimizing and accelerating the clinical development and approval of medical treatments. We hope you find them as insightful and valuable to you now as they were the first time around.

How Unintentional Unblinding Occurs in Clinical Trials

This blog series addresses the trigger points for unintentional unblinding, how partial unblinding can become full unblinding, and some controversial issues related to unintentional and partial unblinding in clinical trials.

Read the Blog Series
Partnering to Advance CNS Treatment Development

In 2021, Calyx advanced its strategy of partnering with best-in-class technology providers to offer innovative imaging biomarkers required to find new treatments for unmet medical needs. Our groundbreaking partnership with Qynapse enables our clients to more confidently assess the full potential of treatments in development for Multiple Sclerosis, Parkinson’s, Alzheimer’s, and Huntington’s disease, as well as other neurodegenerative disorders. And our partnership with Neosoma delivers novel, improved AI-based neuro-oncology imaging assessment to clinical trial sponsors developing new treatments for gliobastoma and other life-threatening neuro-oncological diseases.

Read the Announcements
Improving how we Evaluate Treatment Response in Oncology Research

The Journal for ImmunoTherapy of Cancer recently published ‘Comparison of tumor assessments using RECIST 1.1 and irRECIST, and association with overall survival,’ marking the first time immune-related criteria show correlation with Overall Survival as its most meaningful endpoint in the treatment of cancer patients.

The publication demonstrates the benefit to a subgroup of patients who otherwise would have foregone treatment and survival benefit when relying solely on RECIST 1.1 instead of irRECIST, as irRECIST takes the entire tumor burden including new tumor growth into consideration.

In this webinar, co-authors Peter Eggleton of Merck and Oliver Bohnsack of Calyx – leading experts on RECIST and irRECIST – discuss the implications of these findings, what it means for oncology clinical development and treatment decision-making, and why irRECIST easily can and shall replace outdated RECIST 1.1 on all solid tumor trials going forward.

View the Webinar
150 Orphan Drug Indication Approvals Trusted to Calyx IRT

In rare disease trials, it is critical that trial supplies are available when patients are identified, and that drug overage is minimized – a real challenge due to larger numbers of investigative sites typically required to meet trial enrollment levels. Which is why we’re honored that so many sponsors of orphan drug-designated trials have entrusted their RTSM needs to Calyx IRT and continue to rely on our expertise as they bring safe and effective treatments to patients in critical need.  Learn more about Calyx IRT.

Read the News
The Practicalities of Implementing eCTD 4.0

This blog series reviews the factors regulatory affairs professionals should consider as they prepare for eCTD 4.0 implementation, beginning with people and business processes, the impacts of new concepts and terminologies, and the challenges to be expected.

Read the Highly Requested Blog Series
The Siren Song of Deferred IRT Functionality

What are the consequences of deferring IRT functionality to meet clinical trial start dates? In this Applied Clinical Trials article, Calyx’s Craig Mooney reviews the inefficiencies and potential quality / regulatory risks likely to occur.

Read the Article
Leading CROs join Calyx Partner Program

At Calyx, we have a long history as part of a CRO, so we know how a CRO functions, the challenges you’re up against, and the importance of keeping your customers satisfied. This inside knowledge affects every aspect of our CRO relationships and makes us more efficient and easier to work with.

Our Activate Solutions for CRO Partners Program enables CROs of all shapes and sizes to partner with Calyx and extend our advanced technology and proven services to drive success for their customers. In 2022 we added more CROs to the program – get to know some of them and learn how they’re partnering with Calyx to deliver more value.

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

80 sites enrolling 150 patients: How do you minimize overage without burdening your supply team? Learn how one of Calyx IRT’s advanced trial management options solved the complex in this case study.

Read the Case Study
Seeing the Patient beyond the Data

In this episode of the Calyx Café, Patient Advocate Emily Epstein discusses the importance of supporting clinical trial patients’ mental health and the impact that clinical trial technologies – including DCTs – may have on patient welfare.

Watch the Interview
CTMS Functionalities

Your clinical trials deserve every chance to succeed. And your monitors deserve the most effective tools to improve trial efficiencies. This brochure describes why Calyx CTMS is the solution.

Read the Brochure

We’ll be delivering more valuable content throughout 2023 to help you achieve your clinical development and regulatory objectives. Subscribe to make sure you don’t miss out!

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2021 brought with it many healthcare advances – the most monumental being the availability of numerous COVID vaccines to bring an end to the global pandemic. The year also brought many other advances, and opportunities for life science professionals to stay up to date on the research, technologies, and processes that are driving change in how new medical treatments are developed and ultimately approved for worldwide use.

So here, in case you missed them, are the ten most downloaded articles, white papers, webinars and more produced by Calyx scientific, technical, and regulatory experts last year. Each provides direction and perspective on optimizing and accelerating the clinical development and approval of medical treatments. We hope you find them as insightful and valuable to you now as they were the first time around.

Behind the Breakthrough
Behind the Breakthrough (White paper)

When breakthrough therapy designation is granted, the challenges of clinical trial imaging increase. This white paper presents an insider’s view of what happens when the stakes, scrutiny, and demands of clinical trial imaging are sky-high, to help you get medical imaging done right in your accelerated trial.

READ NOW
Direct-to-Patient Shipments: It’s All in the Details (Published article)

While Direct-to-Patient (DtP)shipping offers potential advantages in improving clinical trial patient engagement, this approach is not as simple as it sounds. This article from International Clinical Trials outlines the pros, cons, and factors to consider when designing decentralized or hybrid clinical trials that include a DtP approach.

READ NOW
Myeloma Trials: The Changing Landscape of Imaging in IMWG Response Assessment (Webinar)

Focusing on the use of PET and addressing key problem areas in response assessment seen frequently in clinical trial settings, this virtual panel of IMWG 2016 authors and imaging experts answered questions about optimizing imaging-related assessments in multiple myeloma trials and shared their expertise in imaging as well as the clinical parameters in myeloma response assessment for running successful myeloma trials.

WATCH NOW
CTMS: Key to Unlocking Clinical Data Power (Podcast)

Listen in and learn how clinical trial management systems can adapt to support positive industry changes, including advances in user interfaces, integrations, and the ability to use CTMS as a data hub to better surface clinical trial risks.

LISTEN NOW
Data, Data, Who Owns the Data? (Calyx Cafe video)

Calyx’s Craig Mooney reflects on recent changes in the regulatory landscape that emphasize the investigative site’s ownership of IRT data collected during clinical trials, and considerations for making progress toward this goal.

WATCH NOW
A Guide to Bringing Regulatory Publishing In-house (Blog)

Regulatory publishing is the backbone of any pharmaceutical, biotech, or medical device business. Do you know what needs to be considered as you bring publishing activities in-house? This guide outlines everything you need to know.

READ NOW
Imaging Biomarkers in Phase 1 Oncology Trials: Choosing the Right Strategy (Webinar)

What biomarker to target? Is Blinded Independent Central Review necessary? Should we ‘Collect & Hold’? In this live panel, Calyx medical imaging experts answered questions about how to succeed in early phase oncology.

WATCH NOW
Understanding the Machine: Can Humans and AI Work Together (Calyx Cafe video)

You won’t want to miss this episode of the Calyx Cafe where our host explains how AI can benefit randomization and trial supply management processes. You’ll never believe who’s asking the questions!

WATCH NOW
Reducing Clinical Trial Lab Data Variability through EDC (Blog)

Learn how to prevent data variability and potential clinical trial delays by normalizing local labs data with advanced EDC systems.

READ NOW
The Ultimate Guide to IRT approaches that help with reducing drug waste (Guide)

Understand the various factors that drive drug wastage in clinical trials and the different IRT approaches that can be used to reduce each in this ultimate guide.

READ NOW

We’ll be delivering more valuable content coming throughout 2022 to help you achieve your clinical development objectives. Subscribe to make sure you don’t miss out!

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The clinical trial management system (CTMS) is a staple of the clinical development industry, providing a centralized repository of data to track the health of clinical trials, which enables sponsors and CROs to make informed decisions throughout trial lifecycles. Changes in how users interact with systems, combined with our high expectations from technology advancements, will help us to achieve significant clinical trial efficiencies. Requiring systems that are open, interoperable, flexible, and continuously adapting to evolving industry trends.

Here we review the CTMS interface and how it has adapted – and will continue to adapt – to better support the industry and deliver real value to users.

CTMS interfaces: The value of integration

Clinical trial management systems have typically been large applications with a single interface designed to cater to many different users, whether they’re a clinical research associate, a site monitor, or an administrator of the system. Typically, the user’s role determines what data they see within the system and their access to features – but the front end remains the same.

However much of the information held within a CTMS comes from integrations with other applications, for example, electronic trial master file (eTMF) and electronic data capture (EDC) systems, meaning they’re machine-to-machine transactions. Considering the big advances we’ve seen in technology, the data platforms underneath, and targeted use of data tailored toward end-users, it’s time to rethink how we interface with a CTMS to make it more efficient and effective, and not have a “one size fits all” approach.

Learn how clinical trial management systems are adapting to support positive industry changes further improve data quality and better surface trial risks.

LISTEN NOW

Flexibility is key

Since every pharmaceutical company and CRO is slightly different in how they process data, a critical component of the CTMS is its flexibility. A flexible CTMS enables the company to tailor their data model to fit their business needs and processes to ensure data can move seamlessly from their own systems into and out of the CTMS. That wider ecosystem also plays into how user interfaces of the future could potentially look, having perhaps a role-based application that links to an eTMF and CTMS solution to complete set tasks, without the user even being aware.

“Calyx CTMS seamlessly takes information from other systems; stores, processes, and moves it on to other systems for future processing – putting information efficiently in the hands of those who need it, to make key decisions and drive successful outcomes.”

– Serena Barker, VP, eClinical, Calyx

Don’t forget user preferences

Considering how we input and access data into and out of the CTMS, the interface should be tailored to each users’ preference. For example, for users at a site, it could be a mobile-compatible interface. For office users and administrators, perhaps something more heavyweight that’s easily accessible and usable via web browsers.

We also need to keep in mind that users may access CTMS data through other systems entirely, via other main applications that are part of the clinical trial process. Or, as the role of citizen developer starts to emerge and evolve, there will be the need for CTMS to interface with very specific and quick applications that are constructed for small and short-lived purposes.

Summary

It’s possible to envision a different future for CTMS, compared to its initial starting point as a very big database with a very big user interface attached to it.

For today’s clinical trial management systems, owing to the diversity within the application estate, To get there, the CTMS must adapt to the demands of its users, be interoperable and flexible – features essential in the reimagining any next-generation CTMS.

Learn how Calyx CTMS is delivering advanced clinical trial management to help sponsors and CROs drive trial efficiencies now, and into the future.

Background 

Listen in as Calyx’s Serena Barker and Stephen Tait discuss how clinical trial management systems can adapt to support positive industry changes ‒ including advances in user interfaces, integrations, and the ability to use CTMS as a data hub ‒ to improve data quality and better surface trial risks.

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