Imaging Solutions

Medical Imaging

Clinical imaging solutions that make a difference.

Imaging Solutions

Medical Imaging

Clinical imaging solutions that make a difference.

Combining science, experience, and technology for trial success.

Calyx Medical Imaging – and the team of imaging experts behind it – have supported over 2,600 clinical trials, delivering reliable data that enables sponsors and CROs to meet their clinical development objectives, time after time.

Whether you’re in early phase development looking to partner, planning to take your compound through regulatory approval, or even seeking Breakthrough Therapy designation, lean on Calyx’s 25+ years’ experience and benefit from a tailored core imaging strategy proven to meet your end goals.

 

Combining science, experience, and technology for trial success.

Calyx Medical Imaging – and the team of imaging experts behind it – have supported over 2,600 clinical trials, delivering reliable data that enables sponsors and CROs to meet their clinical development objectives, time after time.

Whether you’re in early phase development looking to partner, planning to take your compound through regulatory approval, or even seeking Breakthrough Therapy designation, lean on Calyx’s 25+ years’ experience and benefit from a tailored core imaging strategy proven to meet your end goals.

 

Join us for this brief session where Calyx solution designers review how, from earliest protocol design to the final data export, Calyx Medical Imaging has got you covered.

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Join us for this brief session where Calyx solution designers review how, from earliest protocol design to the final data export, Calyx Medical Imaging has got you covered.

Your images. In safe hands.

Since 1997, Calyx has helped global biopharmaceutical companies and CROs successfully leverage medical imaging in their clinical trials. We offer the full range of imaging services to enable transparent and standardized processes and deliver therapeutically-aligned value that allows you to best assess the safety, efficacy, and effectiveness of your compounds.

Your images. In safe hands.

Since 1997, Calyx has helped global biopharmaceutical companies and CROs successfully leverage medical imaging in their clinical trials. We offer the full range of imaging services to enable transparent and standardized processes and deliver therapeutically-aligned value that allows you to best assess the safety, efficacy, and effectiveness of your compounds.

clinical imaging solutions and benefits

Proven experience + Advanced technology = Imaging success

Calyx’s 80+ imaging experts each have a career’s worth of experience merging the clinical, academic, and commercial interests of medical imaging research and are responsible for hundreds of publications and patents in the imaging space, including criteria publications, biomarker development, and imaging in clinical trials.

Our team helps set up your clinical trial imaging effectively and efficiently from the start, providing consultation on trial design, protocol review, clinical data management, EDC design, and site/investigator training.

And we invest in advanced technology including advanced viewers and custom-built eCRFs with smart logic and edit checks as well as cloud-based storage to deliver the reliable, efficient clinical imaging solutions and services you need to optimize your clinical development.

clinical imaging solutions and benefits

When breakthrough designation happens

Earning the FDA’s prized breakthrough therapy designation is just the beginning of the race, one that likely requires the use of an imaging surrogate for preclinical evidence and accelerated approval.

In these instances, study oversight takes on new meaning; Imaging must be performed correctly, and results delivered quickly. From consulting on imaging charters and modalities to suggesting optimal sites, readers, and investigators, working with an experienced imaging provider can be critical.

This was evident in a recent study that Calyx supported, where the need for medical imaging escalated when breakthrough therapy designation was granted for a novel oncology compound and a simple phase I trial design converted to an advanced phase 3 trial practically overnight.

Learn why Calyx Medical Imaging is repeatedly trusted for accelerated approval studies and has been used in the development of half of recently approved oncology breakthrough therapies

Demystifying clinical trial imaging for 25 years.

270
SUPPORTED
APPROVALS
2.6K
STUDIES
75
BREAKTHROUGH
APPROVALS
270
SUPPORTED
APPROVALS
2.6K
STUDIES
75
BREAKTHROUGH
APPROVALS

All therapeutic areas, phases, and complexity.

Calyx has significant experience managing the imaging components of clinical studies – across all therapeutic areas, with varying degrees of complexity, and in all phases of clinical development. Regardless of study phase, Calyx Medical Imaging experts will guide you through the highly nuanced world of clinical trial imaging to ensure your development program succeeds. Or if it’s going to fail, to fail fast.

clinical imaging solutions pie chart

CNS Imaging

Calyx has significant experience managing the imaging components of clinical studies – across all therapeutic areas, with varying degrees of complexity, and in all phases of clinical development. Regardless of study phase, Calyx Medical Imaging experts will guide you through the highly nuanced world of clinical trial imaging to ensure your development program succeeds. Or if it’s going to fail, to fail fast.

In CNS-related disorders, the presentation and progression of brain disease is complex. This causes significant challenges in the clinical development of new CNS treatments, especially for neuro-oncology, neuro-degenerative, and neuro-psychiatry disease.

Calyx’s experienced team of medical imaging experts understand your need to objectively measure CNS disease progression and treatment response. We have provided essential imaging services for nearly 200 clinical trials with CNS imaging, many of which have resulted in approved medical treatments.

By working with Calyx, you have access to some of the industry’s most renowned imaging experts. They work with you to identify the optimal imaging biomarkers based on disease mechanisms and leverage our established operational footprint to acquire complex yet optimized medical images from investigative sites around the world. And our partnerships with best-in-class providers of AI-based solutions deliver quantitative endpoint measurements to help your development program succeed.

Learn more about Calyx’s expertise in CNS clinical trial imaging

In oncology trials, imaging experience matters.

Calyx scientific consultants have the industry’s most extensive experience in oncology clinical trial imaging. We’ve successfully managed the imaging components of over 1,500 clinical trials across 90 unique oncology indications. This includes more than 50 pivotal studies – where imaging data supported successful submissions to regulatory agencies – and over 75 trials of compounds that were designated breakthrough therapies.

Calyx’s expert scientific and medical team is experienced in the successful implementation and operationalization of hematology trials, providing solutions to manage complex clinical data and advanced imaging. Our experience includes 300+ hematology trials, including support of 40+ approvals in Lymphoma, CLL, Waldenstorms and Multiple Myeloma.

 

Calyx has close collaborations with key opinion leaders including Dr. Bruce Cheson, Dr. Joseph Mikhael and Dr. Shaji Kumar, which enables us to address criteria gaps and we work closely with a large pool of board-certified reviewers from renowned institutes with extensive experience in various hematology criteria including Lugano, iwCLL, IMWG, LYRIC, RECIL etc.

 

You can trust the Calyx Medical Imaging team to provide reliable consultation on hematology trial design, template charters, and applications based on our lessons learned from previous studies incorporating reviewer, KOL, and regulatory feedback.

Calyx provides a wide range of proven imaging services for Neuro-oncology clinical trials. Our network of scientific advisors and in-house expertise allows for full spectrum service offerings to help take your product from discovery to market.

 

Calyx’s experience in Neuro-oncology imaging includes:

  1. Primary or metastatic tumor detection/propagation on contrast-enhanced CT & MRI utilizing appropriate criteria and analysis approaches
  2. Superimposition of sequences to segment out tumor and edema volumes and follow over time
  3. Advanced MRI analysis per study needs

In oncology trials, imaging experience matters.

Calyx scientific consultants have the industry’s most extensive experience in oncology clinical trial imaging. We’ve successfully managed the imaging components of over 1,500 clinical trials across 90 unique oncology indications. This includes more than 50 pivotal studies – where imaging data supported successful submissions to regulatory agencies – and over 75 trials of compounds that were designated breakthrough therapies.

Calyx’s expert scientific and medical team is experienced in the successful implementation and operationalization of hematology trials, providing solutions to manage complex clinical data and advanced imaging. Our experience includes 300+ hematology trials, including support of 40+ approvals in Lymphoma, CLL, Waldenstorms and Multiple Myeloma.

 

Calyx has close collaborations with key opinion leaders including Dr. Bruce Cheson, Dr. Joseph Mikhael and Dr. Shaji Kumar, which enables us to address criteria gaps and we work closely with a large pool of board-certified reviewers from renowned institutes with extensive experience in various hematology criteria including Lugano, iwCLL, IMWG, LYRIC, RECIL etc.

 

You can trust the Calyx Medical Imaging team to provide reliable consultation on hematology trial design, template charters, and applications based on our lessons learned from previous studies incorporating reviewer, KOL, and regulatory feedback.

Calyx provides a wide range of proven imaging services for Neuro-oncology clinical trials. Our network of scientific advisors and in-house expertise allows for full spectrum service offerings to help take your product from discovery to market.

 

Calyx’s experience in Neuro-oncology imaging includes:

  1. Primary or metastatic tumor detection/propagation on contrast-enhanced CT & MRI utilizing appropriate criteria and analysis approaches
  2. Superimposition of sequences to segment out tumor and edema volumes and follow over time
  3. Advanced MRI analysis per study needs

clinical imaging solutions and muskuloskeletal

Musculoskeletal imaging

Calyx is a leading provider of imaging core lab services, offering proven clinical imaging solutions to standardize musculoskeletal (MSK) imaging endpoint assessments. The key to our success can be credited to a dedicated and experienced operational and medical team.

Our flexibility in choosing readers enables you to utilize virtually any KOL as an expert reader. We collaborate with you to identify the best possible readers and read model for your trial. Due to the technical nature of MSK assessments, having an expert and small pool of readers is essential to balance read volumes while maintaining high quality and ensuring low inter-reader variability.

 

Our primary goal is to provide accurate and precise assessments by expert readers. To achieve this, we ensure standardization in image acquisition by providing imaging templates, positioning devices, and monitoring instrument quality control, as well as consistent scanner calibration across sites within a study.

 

Standardization of image acquisition allows optimal image quality at baseline and consistent imaging at follow-up; this results in increased sensitivity and power to demonstrate treatment effects. Our staff compares the results of all follow up scans to baseline to ensure consistent positioning across timepoints.
We have invested in creating state of the art technology to facilitate the use of complex criteria across the MSK spectrum including:

 

  • Customizing analysis application based on criteria author’s reading preference
  • Integrating advanced imaging algorithms for muscle and fat segmentation into our standard imaging workflow
  • Investing customized solutions for monitoring drift in scanners over time, as well as proprietary software to harmonize DXA imaging across multiple manufactures
  • Expedited reporting, including, eligibility results and safety endpoints, for example, confirmation of fracture, T and Z scores and excessive bone loss

clinical imaging solutions and muskuloskeletal

Musculoskeletal imaging

Calyx is a leading provider of imaging core lab services, offering proven clinical imaging solutions to standardize musculoskeletal (MSK) imaging endpoint assessments. The key to our success can be credited to a dedicated and experienced operational and medical team.

Our flexibility in choosing readers enables you to utilize virtually any KOL as an expert reader. We collaborate with you to identify the best possible readers and read model for your trial. Due to the technical nature of MSK assessments, having an expert and small pool of readers is essential to balance read volumes while maintaining high quality and ensuring low inter-reader variability.

 

Our primary goal is to provide accurate and precise assessments by expert readers. To achieve this, we ensure standardization in image acquisition by providing imaging templates, positioning devices, and monitoring instrument quality control, as well as consistent scanner calibration across sites within a study.

 

Standardization of image acquisition allows optimal image quality at baseline and consistent imaging at follow-up; this results in increased sensitivity and power to demonstrate treatment effects. Our staff compares the results of all follow up scans to baseline to ensure consistent positioning across timepoints.
We have invested in creating state of the art technology to facilitate the use of complex criteria across the MSK spectrum including:

 

  • Customizing analysis application based on criteria author’s reading preference
  • Integrating advanced imaging algorithms for muscle and fat segmentation into our standard imaging workflow
  • Investing customized solutions for monitoring drift in scanners over time, as well as proprietary software to harmonize DXA imaging across multiple manufactures
  • Expedited reporting, including, eligibility results and safety endpoints, for example, confirmation of fracture, T and Z scores and excessive bone loss

Improve data quality throughout the imaging lifecycle.

Calyx’s Medical Imaging expertise is backed by a robust operational infrastructure that ensures standardized, consistent processes, from selecting the ideal biomarker to minimizing reviewer discordance and improving the experience for investigative site personnel.

Imaging biomarkers can provide a great deal of valuable information during the development of new medical treatments. But the role they play – and how to go about deciding which biomarker to use for your clinical development phase – will vary based on numerous factors.

 

Calyx scientific consultants leverage their broad experience to help you set a strategy and implement the right imaging biomarker to meet your clinical development objectives, balancing the tensions that inherently exist in clinical trial data acquisition and driving your trial’s success.

Calyx recommends an innovative index to monitor individual reader performance; the Reader Discrepancy Index (RDI), which considers both the overall adjudication rate for a study and the individual adjudication agreement rate for each reader. The RDI indicates the percentage of discrepant/disagreed cases for a given reader across the total number of cases read, where a low RDI value indicates better reader performance. The RDI improves upon the information obtained from the adjudicator agreement rate by additionally incorporating data about the reader discordance, making it a more reliable index.

 

In addition to tracking RDI for our reviewers, Calyx also employs the Reader Assessment Paired Matrix (RAPM) to proactively monitor reviewer performance. This method tracks all reader assessments against other readers on the study, constantly calculating the statistical likelihood that a reader is not making assessments per protocol. This allows for early intervention and training, ensuring the highest quality data.

As clinical trial imaging becomes more common and is being requested earlier in development due to accelerated approvals, demands on study coordinators and radiology staff continue to increase. Thus, it is essential that the requirements for sites are simple and clear and that studies are designed with the sites’ needs clearly defined upfront.

 

Calyx helps to keep site personnel engaged in imaging trials by extending our expertise, proven processes, and advanced technology that simplifies day-to-day tasks; allowing these critical stakeholders to return their focus to what matters – their patients and helping to support drug approval.

Improve data quality throughout the imaging lifecycle.

Calyx’s Medical Imaging expertise is backed by a robust operational infrastructure that ensures standardized, consistent processes, from selecting the ideal biomarker to minimizing reviewer discordance and improving the experience for investigative site personnel.

Imaging biomarkers can provide a great deal of valuable information during the development of new medical treatments. But the role they play – and how to go about deciding which biomarker to use for your clinical development phase – will vary based on numerous factors.

 

Calyx scientific consultants leverage their broad experience to help you set a strategy and implement the right imaging biomarker to meet your clinical development objectives, balancing the tensions that inherently exist in clinical trial data acquisition and driving your trial’s success.

Calyx recommends an innovative index to monitor individual reader performance; the Reader Discrepancy Index (RDI), which considers both the overall adjudication rate for a study and the individual adjudication agreement rate for each reader. The RDI indicates the percentage of discrepant/disagreed cases for a given reader across the total number of cases read, where a low RDI value indicates better reader performance. The RDI improves upon the information obtained from the adjudicator agreement rate by additionally incorporating data about the reader discordance, making it a more reliable index.

 

In addition to tracking RDI for our reviewers, Calyx also employs the Reader Assessment Paired Matrix (RAPM) to proactively monitor reviewer performance. This method tracks all reader assessments against other readers on the study, constantly calculating the statistical likelihood that a reader is not making assessments per protocol. This allows for early intervention and training, ensuring the highest quality data.

As clinical trial imaging becomes more common and is being requested earlier in development due to accelerated approvals, demands on study coordinators and radiology staff continue to increase. Thus, it is essential that the requirements for sites are simple and clear and that studies are designed with the sites’ needs clearly defined upfront.

 

Calyx helps to keep site personnel engaged in imaging trials by extending our expertise, proven processes, and advanced technology that simplifies day-to-day tasks; allowing these critical stakeholders to return their focus to what matters – their patients and helping to support drug approval.

Partner with us for clinical imaging solutions.

Calyx Scientific Consulting offers valuable services to optimize your medical imaging investment. The benefits of working with Calyx Scientific Consulting include:

Diamond Icon-cirlce
successful early phase clinical trials
Tools Icon-cirlce
Foundation for later phase trial strategies
Sheild Icon-cirlce
Identifying risk signals earlier
Checklist Icon-cirlce
Streamlining regulatory approvals

Partner with us for clinical imaging solutions.

Calyx Scientific Consulting offers valuable services to optimize your medical imaging investment. The benefits of working with Calyx Scientific Consulting include:

Tools Icon-cirlce
Foundation for later phase trial strategies
Diamond Icon-cirlce
successful early phase clinical trials
Sheild Icon-cirlce
Identifying risk signals earlier
Checklist Icon-cirlce
Streamlining regulatory approvals

Our Medical Imaging Experts

With experience from 2,600+ imaging studies and having supported over 250 new drug approvals – including half of the recently approved oncology treatments designated as breakthrough therapies – Calyx Scientific Consultants can help you design and implement an imaging strategy that gets your compound across the finish line. Faster.

Our Medical Imaging Experts

With experience from 2,600+ imaging studies and having supported over 250 new drug approvals – including half of the recently approved oncology treatments designated as breakthrough therapies – Calyx Scientific Consultants can help you design and implement an imaging strategy that gets your compound across the finish line. Faster.

Library

Satisfaction of search (SOS) and new lesions identification on imaging in central review for clinical trials

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Using reader disagreement index as a tool for monitoring impact on read quality due to reader fatigue in central reviewers

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Assessing Prostate Cancer on Imaging in Clinical Trials

This whitepaper highlights Calyx’s expertise in using and adapting the PCWG3 criteria to address imaging-based objectives and endpoints in prostate cancer clinical trials.
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Higher Data Reliability of Blinded Independent Central Review Compared to Local Evaluation

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