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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

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.


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