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Clinical Trial Services

Resoundant offers Core Lab services in collaboration with the Mayo Clinic scientists and medical professionals who invented MR Elastography over 20 years ago.

 

Today, Resoundant and Mayo Clinic continue to support the ongoing advancement of MRE through joint research and development activities. Resoundant Core Imaging personnel also hold joint appointments in Mayo’s MRE laboratory, and are recognized as experts in the field of MRE.  The MRE laboratory at Mayo Clinic has held continuous grant support from the National Institutes of Health since 1995.

 

This unique relationship offers clinical trial sponsors the ability to tap into sophisticated products and tools developed through rigorous Mayo Clinic academic research, but in a nimble, low cost, and industry-friendly manner.  These services include image central reading, protocol development, scientific advisory services, site training, and site qualification.  

Our specialization,

at your service

As the developers of MRE, we specialize in a powerful marker that can quickly & accurately assess fibrosis stage. 

 

For trials of chronic liver diseases, our in-house analytics pair MRE with PDFF so trial sponsors can reliably enrich study populations and support more rapid go/no-go decision making - all at a low cost and in an extremely short amount of scanner time for the subject.

Experience matters

Our staff has extensive experience in the use of quantitative imaging in clinical trials and can deliver a rapid, accurate, and quantitative assessment of liver health from MRE+PDFF expert central analysis. Our goal is to streamline the image analysis process for drug development clinical trials in order to provide an accurate, rapid, and biologically relevant evaluation of liver health for trial enrollment, safety, monitoring, and endpoints.

 

Resoundant personnel are recognized leaders in the field, with deep experience in the acquisition and post-processing of key MR-based biomarkers - notably MRE and PDFF.  Collaboration with our team offers you access to the technology’s inventors, unparalleled experience, and state of the art technology and post-processing tools.

 

Altogether, our staff have served as consultants on completed and ongoing trials, as well as international consortia. These roles have included protocol development, scientific advisory services, imaging central reading, site training, and site qualification.

Our Work

Number of Trials

Number of Exams

Phases

Indications

8

1500+

IIa-IIb

NAFLD

NASH

HCV

HBC

PBC

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Core Services

Dial-in just the amount of support you need.

Expert Image Reading

Because our analysts are recognized leaders in MRE, you gain the confidence that one of your trial’s most important markers is being evaluated by the recognized experts in the field.

Advanced Analytics

Our commitment to advancing MRE in both the clinical and research settings has resulted in proprietary, advanced analysis tools unique to Resoundant. These analytics can reduce errors, decrease variability through automation, and allow for more rapid turnaround.

Resource Allocation

Having stewarded the installation of MRE on over 1,500 MRI scanners worldwide, we can either help locate MRE capabilities or explore technological acquisitions to get a preferred practice equipped wtih MRE for the trial.

Data Management

Resoundant is committed to delivering efficient, HIPPA-compliant, secure transfer of images utilizing solutions that are fully compliant with HIPPA/HITECH HITRUST and SOC2 compliant with an FDA-approved viewer and comprehensive HL7 support.

Additional Services

Study Start-up

From governing documents to eCRF, imaging manuals and charters, our experts can help create high-impact study documentation. 

Regulatory Support

Building upon our own work on MRE biomarker qualification, we can advise on MRE for submission to regulatory authorities.

Quality Control

Our validated QC infrastructure ensures high-quality data with rapid turnaround while working with sites directly on any quality issues that may arise.

Site Support

Resoundant’s experts are always available via our dedicated hotline and other timely support resources to ensure each acquisition is optimal.

Study Design Consultation

No matter the context of use, you can engage our team at any point in your design process to ensure accurate, precise, and reproducible MRE results.

Training Needs

Whether through online courses, live webinars, or onsite training, we ensure that each site meets our standards.

 

Levels of Service that

Fit Your Needs

Our goal is to fit seamlessly into your existing architecture and workflow. 

 

Whether you need end-to-end support for imaging of fibrosis and steatosis, or you simply need more tailored levels of support that fit into your current workflow, we are here to support you and your sponsors along the drug development journey.

Site Support +

Advanced Tools +

Central Reads

Full End-to-End

Resoundant’s experts are always available via our dedicated hotline and other timely support resources to ensure each acquisition is optimal.

Resoundant’s experts are always available via our dedicated hotline and other timely support resources to ensure each acquisition is optimal.

Advanced Tools +

Central Reads

Central Reads

Proprietary analytics that decrease variability and speed turnaround time 

Sometimes you just need the best image analysts.

Why MRE for Clinical Trials

Many clinical trials focused on liver diseases, such as non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), require detection and staging of liver fibrosis. Liver biopsy with histopathologic analysis has been the traditional tool for this purpose but is not ideal due to cost, invasiveness, and sampling error. There is a widely-recognized need for non-invasive approaches to reliably assess liver fibrosis at a significantly lower cost and with greater technical capacity.

  

MR Elastography (MRE) is an MRI-based technique for quantitatively assessing liver fibrosis, with high diagnostic performance that has been extensively documented in the literature and recognized by the US Centers for Medicare and Medicaid Services.

With over 1,500 installations worldwide (including 600+ in the United States), MRE is widely available and provides a more comfortable, more accurate, and less costly alternative to liver biopsy for assessing hepatic fibrosis. 

 

The combination of MRE and PDFF in a single, rapid exam for steatosis and fibrosis staging - as well as the use of advanced in-house tools - provide a comprehensive assessment of liver health by helping to distinguish NAFLD/NASH phenotypes. For longitudinal research, MRE can also be used to assess disease progression, regression, and treatment response. Together, our powerful tools can bring promising therapies closer to realization more rapidly, more confidently, and at far less cost than ever before.

 

Want more info? Let's chat.

Use the tools below to schedule a one-on-one virtual session with one of our clinical trial services experts.

  • New to MRE? We can give you a high-level overview.

    30 min

  • A deep dive into the services and expertise of the Resoundant team.

    30 min

  • Fibrosis is a critical biomarker. Find out how MRE can get it right.

    30 min

 
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© 2020 by Resoundant, Inc.