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 | [email protected] | +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 | [email protected] | +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 | [email protected] | +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 | [email protected] | +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

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.

Imagine you’re in charge of running multiple international banks. And each of those banks processes multiple transactions every day that require currency conversions. Would you ask the tellers at each site to manually convert each deposit, withdrawal, transfer, etc. before completing the transaction?

Of course you wouldn’t. To ensure the correct amounts are being processed your staff would rely on automated currency converters, which ensure correct amounts are processed and recorded every time.

The same concept is true in clinical trials that use EDC systems to capture data from local labs. We explore how it works and the benefits it delivers here.

Background

Local laboratories are commonly used in clinical trials because they are on-site or close to the investigator site, and they often provide data that are needed immediately for treatment or randomization decisions.

But, as studies are conducted around the globe, there are differences in the instruments that local labs use and the units of measurement they produce. Instruments can be calibrated differently, use different reagents, use different units of measure and normal ranges. This makes direct comparisons of lab values across local laboratory sites difficult and introduces additional time required by investigative sites to manually convert values to ensure their consistency and compliance with the protocol.

Dianne Piccone Cologne and Clinical Trial lab data

“By leveraging an EDC local labs module, lab data can be captured and normalized across patients so that medical monitors and study teams can look at the data holistically.”

– Dianne Piccone, Director, Solution Consulting, Calyx

So, how do you prevent the data variability, increased site staff burden, and potential trial delays that arise when local laboratories are used in clinical trials?

The EDC Local Labs Module

By leveraging a local labs module within an Electronic Data System (EDC), lab data can be captured as it is provided and then normalized across patients and throughout the study so that medical monitors and study teams can look at the data holistically, to identify safety findings and trends.

Local lab results are entered into the system, then pre-configured conversion factors normalize the data, in real-time, into a common standard unit. Normal reference range values for each lab test, with gender and age attributes can be maintained, and the system produces an alert for out-of-range values. Lab data sets can also be exported at any time for analysis.

Data Normalization Benefits

A local labs module within an EDC system allows study teams to gain important information earlier with a glimpse into the overall dataset sooner. Study teams can identify and overcome common issues in data collection to avoid an accumulation of errors or inefficiencies upon the closeout of a clinical trial.

Summary

For many clinical trials, laboratory data comprises a large portion of all data collected. It can be inherently complex, and the time it takes to manually normalize it could be better spent by an investigative staff meeting other clinical trial requirements.

By leveraging a local labs module within an EDC system, trial sponsors normalize the collection of disparate lab value, simplify processes for site staff, and ensure the validity of the important clinical trial data.

And that’s value you can bank on.

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