Imaging for clinical trials

At Median we’re determined to push the boundaries of what imaging technology can achieve, to help develop next generation treatments with the potential to save or improve the lives of millions. We’re already transforming the use of medical images in clinical trials and patient care; extracting the highest quality, most advanced imaging biomarkers to set the standard for developing new therapies, diagnosing disease and treating patients. We’re helping biopharmaceutical organizations around the world make quicker, better informed decisions, bringing new therapies closer every day.

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‘Oncology is the most significant therapeutic area in terms of drug industry R&D expenses and represents the largest segment (approximately 38%) of the clinical trials market’

Imaging solutions for clinical trials

Imaging is a complex and critical component of many clinical trials. Imaging endpoints require high quality, accurate, and predictive data to be successful. The right people and best technology ensure therapies are properly assessed, and Median brings together its imaging specialists, superior platform, and expert teams to support trial sponsors.

Our clinical trials service provides extensive expertise

  • Imaging protocol design
  • Site training and management
  • Independent radiological review
  • Advanced imaging biomarkers
  • Image quality, analysis, and reporting

Our global imaging services and integrated image analysis technologies provide quality, speed, and advanced technology to access and leverage data for phase I through phase III clinical trials.

Early-stage study advantages

  • Direct correlation of advanced imaging biomarkers and standard RECIST 1.1
  • Fast and informed go/ no go decisions

Late-stage study benefits

  • Easy access to high quality data and images
  • High level data integrity for regulatory submission

Quality accreditations

Services

Median offers a full suite of global imaging contract research capabilities for early- and late-phase studies:

Study Start Up

  • Imaging Charter and Workflow Development
  • Imaging Site Technical Evaluation and Qualification
  • Imaging Manuals and Forms Development
  • Independent Review SOP Development
  • Imaging Site Study Materials Development
  • Imaging Site Training

Image and Clinical Data Management

  • Image Data Collection and Tracking
  • Image Quality Control
  • Image Query Resolution
  • Site Support

Scientific Consulting

Independent Reviews

  • Independent Review Charter Development
  • Image Data Transfer Plan
  • Imaging eCRF and Independent Review Database
  • Independent Review Set-up
  • Blinded Reader Selection
  • Reader Training
  • Blinded Image Review Session Management
  • Review Support
  • Independent Review Database Transfers

Image Data Processing and Site Support

  • Data Management
  • Image and Associated Record Storage
  • Storage Systems Maintenance

Study Close-Out

  • Project Data Archiving
  • Final Reporting

Technology

Median is at the heart of innovative information and healthcare technologies. Our core technology, Lesion Management Solution (LMS), automates and standardizes image management and endpoint review to ensure the highest quality data for fast, informed decisions.

  • Limits reader subjectivity
  • Reduces reader variability
  • Increases accuracy and reproducibility
  • Decreases data queries
  • Streamlines data management
  • Provides routine and advanced imaging biomarkers
  • Offers superior sponsor reporting

Operational excellence

We deliver superior levels of customer service for phase I through III oncology trial imaging services:

  • Dedicated team with expertise in all critical disciplines
  • Customized services for trial design
  • Imaging consulting for protocol design and data reviews
  • Advanced imaging criteria and regulatory trends training

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Imaging endpoints

Median images are a crucial part of cancer care, from diagnosis to follow up, and imaging biomarkers provide unparalleled quantitative information on disease status and evolution. Consequently, imaging biomarkers are key efficacy endpoints for new candidate oncology drugs and innovative therapeutic programs.

Clinical trial image interpretation and management can be challenging.  Interpretation variability, censoring bias, and complex data workflows can all present issues.

Median’s experience, expertise, and technology address these issues, which is why so many biopharmaceutical sponsors choose Median as the Imaging CRO of choice.

The Median Advantage

  • Setting a new imaging standard for oncology trials

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  • Image management automation
    • Creates speed and efficiency
    • Significantly reduces human error
    • Increases results reproducibility
  • Core technology cleared by FDA and other regulatory bodies
  • Unmatched quality controls, validation, and testing

Therapeutic areas

Median’s medical imaging expertise offers world-leading imaging solutions for clinical studies in a range of therapeutic fields.

Oncology

With hundreds of novel cancer therapeutics tested every year, oncology is the fastest growing sector of drug development. Median has the expertise, experience, and medical imaging technology needed to successfully support oncology clinical trials. We work on studies around the world, and our teams have the specialized oncology experience required to deliver the highest quality service and independent image review.

Other therapeutic areas

Our services are ideally suited to support studies in a range of indications – please contact us to discuss further therapeutic fields.

Modalities

Imaging modality and endpoint selection

Imaging modality and endpoint selection is critical for clinical trial success. At Median, imaging services are the core of our business, and our customers access our expertise to inform the correct selection, ensure multi-site implementation, and maximize imaging acquisition and management quality.

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