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.

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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®.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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