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

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.

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.

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.

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.

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.

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.

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.

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!

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

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.

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.

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.

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.

Advanced clinical trial management system on Azure cloud technology reduces risks in clinical trial operations

Nottingham, UK – April 14, 2021 — Calyx, the eClinical and Regulatory solutions and services provider most relied on for solving complex data challenges in clinical research, today announced the availability of Calyx CTMS v15.0, an advanced clinical trial management system for reducing risk and improving efficiencies in clinical development.

Jamie Moss, Chief Operations Officer, Calyx

Calyx CTMS on Microsoft’s Azure cloud technology delivers robust features that simplify the oversight of clinical trial operations, improve data quality, and reduce trial timelines and cost. Some of the features of CTMS v15.0 enable trial sponsors to:

  • Better manage clinical trials in today’s changing landscape with tools that address the complexities of traditional and decentralized clinical trials
  • Centralize the operational data of current and historical trials into a single source, providing actionable insights to support informed decision making and drive trial success
  • Boost productivity by seamlessly connecting to the clinical development ecosystem through standard and custom API integrations
  • Conduct monitoring visits anywhere, regardless of internet connectivity via the smartphone- accessible Calyx CTMS mobile application

“A key component of Calyx’s end-to-end approach to improving trial efficiencies, CTMS v15.0 represents a leap forward for clinical trial sponsors striving to accelerate clinical development in today’s competitive market,” said Jamie Moss, Chief Operating Officer at Calyx. “By leveraging the system’s cloud-based technology, improved interconnectivity, and easily accessible mobile app, clinical trial sponsors are taking the next step in reducing trial risks and ensuring compliance with operational processes to bring new treatments to patients sooner.”

Click here for more information on Calyx CTMS.

About Calyx

Through innovative eClinical 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 more than 25 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.

Media Contact:

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

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