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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

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Expertise in medical imaging, IRT, and EDC solution delivery to benefit ProTrials’ worldwide customers

Nottingham, England and Morrisville, NC – March 21, 2022 – Calyx, the eClinical and Regulatory solutions and services provider relied on for solving complex data challenges in clinical research, today announced it has been named an approved partner by ProTrials Research, Inc., a mid-sized full-service clinical research organization (CRO) specializing in delivering clinical operations services to the pharmaceutical, biotechnology, and medical device industries.

“We’re pleased to partner with Calyx and are confident that our customers will benefit from the scientific, medical, and clinical expertise they have honed during their 30 years of delivering reliable eClinical solutions to the clinical development industry,” said Christy Meyer, Director, Quality Assurance, ProTrials.

The partnership enables Calyx to extend its proven medical imaging, interactive response technology (IRT) and electronic data capture (EDC) solutions and services to help ProTrials’ worldwide customers achieve their clinical development objectives. ProTrials’ clients will leverage Calyx’s innovative technology to improve the reliability of clinical trial outcomes data, ultimately enabling them to deliver safe and effective medical treatments to patients in need.

“We look forward to delivering the important imaging and eClinical data ProTrials’ customers rely on as they evaluate the safety and efficacy of often life-saving medical treatments,” said Elizabeth Dalton, Vice President, Technical Solutions, Calyx. “We’re honored that ProTrials selected Calyx to support them as they deliver on their commitment to improve the health and extend the lives of patients worldwide.”

Click here for more information on how CROs – and their clients – benefit from partnering with Calyx.

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.

About ProTrials Research, Inc.

ProTrials Research, Inc., is a mid-sized full-service clinical research organization (CRO) headquartered in Los Gatos, CA, with clinical operations personnel located throughout North America and across the world. Since our launch in 1996 as a woman-owned business, we have been driven by a shared commitment to provide outstanding service to the clinical research industry. To this day, that commitment remains our guiding principle and is reflected in our high-repeat business rate. ProTrials works with sponsors in the pharmaceutical, biotechnology and medical device industries to deliver high-quality clinical operations services such as study management, investigative site monitoring, grant services, project and program management, biometrics including biostatistics, pharmacovigilance, and associated clinical development services. Our operations support expands into Europe, Asia-Pacific, and Latin American countries. To learn how ProTrials Research, Inc., can help advance your clinical trial success, please visit us at www.protrials.com or call 650.386.7712.

Contact:

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

Depth and diversity of Calyx scientific and technical teams’ experience extended to ClinChoice’s worldwide clients

Nottingham, England and Morrisville, NC – March 7, 2022 – Calyx, the eClinical and Regulatory solutions and services provider relied on for solving complex data challenges in clinical research, today announced it has been named a preferred provider of medical imaging and eClinical solutions by ClinChoice, a leading full-service clinical research organization (CRO).

“We chose to partner with Calyx due to their tenured scientific, medical, and technical teams who possess a depth and diversity of experience in providing reliable data outcomes,” said Tiepu Liu – President, Global Biometrics, ClinChoice. “We’re pleased to name Calyx a preferred partner and know our customers will benefit from their proven approach to optimizing clinical research.”

ClinChoice is committed to providing deep domain experience through reliable partnerships in support of clinical research trials around the world. As part of this partnership, ClinChoice will offer Calyx’s Medical Imaging and eClinical solutions to their pharmaceutical, biotechnology, medical device, and consumer product clients.

“We’re honored that ClinChoice chose to partner with Calyx,” said John Blakeley, Chief Commercial Officer of Calyx. “We look forward to a long relationship and to delivering the high-quality solutions and reliable services their worldwide customers have come to expect from this leading CRO.”

Click here for more information on how CROs – and their clients – benefit from partnering with Calyx.

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

Leading pharmaceutical company trusts Calyx to meet accelerated timelines and support multi-year trials

Nottingham, England and Morrisville, NC – February 21, 2022 – Calyx, the eClinical and Regulatory solutions and services provider relied on for solving complex data challenges in clinical research, today announced its electronic data capture (EDC) system has been selected by a leading pharmaceutical company to capture Real World Evidence (RWE) data for a global, late phase study.

The global company selected Calyx EDC based on its proven effectiveness in capturing important clinical trial patient data during lengthy, global studies. Calyx’s ability to expedite the delivery of a reliable, cost-effective solution to meet the pharmaceutical company’s accelerated study timelines and continuous data collection needs were critical to its selection.

“We’re thrilled to work with this leading pharmaceutical company and to extend our 30 years’ experience in delivering reliable, high-quality data to help them fully understand the long-term effects of their medical products.” said Juan Munoz-Pujol, Vice President, IRT and EDC at Calyx.

Click here for more information on Calyx EDC.

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

Trust in Calyx EDC based on decade-long relationship drives contract extension decision

Nottingham, England and Morrisville, NC – February 14, 2022 – Calyx, the eClinical and Regulatory solutions, and service provider relied on for solving complex data challenges in clinical research, announced today that a Top 20 specialty pharmaceutical company will continue to rely on Calyx’s electronic data capture (EDC) system for a series of upcoming, early phase studies.

The Top 20 specialty pharmaceutical company is furthering its commitment to the relationship it has formed with Calyx and extending its use of the EDC system in multiple additional studies scheduled to begin this year. The company ‒ which has relied on Calyx EDC for over a decade ‒ will use the proven, robust system to capture important clinical trial data in early phase studies of new compounds being developed for diabetes, obesity, and NASH.

“We are so proud of the trust this Top 20 specialty pharmaceutical company places in Calyx EDC and we are delighted to continue supporting their efforts to bring advanced treatment options to the many people living with metabolic disorders and other diseases around the world,” said Juan Munoz-Pujol, Vice President, IRT and EDC at Calyx.

Click here for more information on Calyx EDC.

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 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.

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

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!

SUBSCRIBE

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