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; extracting the highest quality, most advanced imaging biomarkers to set the standard for developing new therapies. We’re helping biopharmaceutical sponsors around the world make quicker, better informed decisions, bringing new therapies closer every day.

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End-to-end imaging services for sponsors everywhere

Imaging is a true key component in clinical trials. Median brings together its imaging specialists, imaging platform iSee®, and expert teams to support biopharma sponsors in their clinical trials and exceed their expectations.

With our HQ based in Europe (France), and our two subsidiaries in the US and China (Shanghai), we deliver globally, providing best in class end-to-end imaging services to our biopharma clients. We also partner with major Contract Research Organizations (CRO), for whom our imaging solutions complement their traditional clinical trials expertise.

We are experts in oncology imaging and we deliver services for oncology trials from Phase I to IV. In HY2, 2019, Median exceeded the milestone of 100 clinical studies contracted with biopharmaceutical sponsors, with a growing number of phase III studies and immuno-oncology trials (+45%). Our approach is designed to improve clinical trial cost-effectiveness and efficiency.

Powering oncology trials with iSee®, our imaging platform

Our proprietary software platform iSee® provides expert oversight of our customers’ images, automating and standardizing lesion detection, selection, and measurement, reducing human error and missed lesions, and reducing results variability.

iSee® extracts standard and novel biomarkers using multiple imaging criteria, from RECIST 1.1 to more specific criteria such as volumetric assessments, mRECIST or iRECIST. Our technology focuses on the evaluation of new oncology drugs including immuno-oncology drugs and provides customization based on our customer’s clinical trial needs. iSee® can cover a wide range of solid tumors in cancer indications.

Download: Imaging for Oncology Clinical Trials

Operational excellence for high-quality imaging CRO capability

We leverage our experience, know-how, and technology in each area of clinical development:

Regulatory Compliance and quality: Our team has extensive practical knowledge of clinical trial regulatory requirements for image management. Our clinical services and technology platform iSee® comply with ICH/GCP guidelines, FDA, EMA and NMPA regulations, and clinical study protocols. As of Oct 31, 2019, Median has gone through 36 client audits and has been successfully inspected by the FDA twice in the past three years.

36


Client audits

2


Successful FDA inspections

Project Management: Our team includes collaboration professionals with a thorough understanding of project management practices, tools, and skills. Our project management processes and practices are derived from the international PMI standard and adapted to specific clinical trial requirements.

Data Management and Quality Control: Our iSee® platform provides structured image, disease and lesion data handling. Our automated and standardized processes enforce image management and quality control with automated checks conducted as early as possible and throughout the entire data collection process using Median’s integrated software solutions. Median’s solutions provide seamless, automated interoperability with clinical trial management and electronic data collection systems.

Biostatistics and Data Analysis: Median provides significant data analysis and biostatistics capabilities, including know-how, tools, and methodology, for use in our customers’ clinical trials.

IT Capabilities: Our cloud-based IT infrastructure is optimized to increase uptime, while our remote data centers provide power and connection redundancies, ensuring continuity of operations and scalable service.

Our imaging contract research organization services in 6 steps

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1. Study Start Up

2. Image and Clinical Data Management

3. Scientific Consulting

4. Independent Reviews

5. Image Data Processing and Site Support

6. Study Close-Out

What does this mean for our sponsors and partners

  • For phases II & III pivotal trials, Median Technologies’ stringent quality system ensures reliable results and readiness for potential inspections from regulatory agencies.
  • For phases I and II, Median Technologies’ flexibility and access to novel imaging criteria, in addition to the standard ones, allows for a better assessment of the molecule and make better informed Go/No Go decisions.
  • Median Technologies has also a unique capability to provide on-going reads with short turnaround time and is supported by a proprietary technology that reduces assessment variability through edit checks and automation.
  • Access to advanced criteria and novel imaging biomarkers, seamless comparison to RECIST
  • Short TAT with on-going reads
  • Eligibility and Progressive Disease confirmation with provision of comprehensive report and images
  • Integration of data into CRO/Sponsor database
  • Engagement and flexibility of small dedicated experienced teams

More meaningful data in regard to disease evolution and faster Go/No Go decisions

  • Global reach, proven expertise
  • Quality data generated by imaging system based on an FDA-cleared medical device (510K)
  • 2 FDA audits with no findings
  • Eligibility and Progressive Disease confirmation with comprehensive reports and images to support the evidence
  • 7 regulatory approvals, 4 indications and 3 drugs

Integrity of data, better dossiers for FDA submission and value dossiers for payers

  • True Integration at all operational and technical levels
  • Consulting/expertise to complement and enhance request for proposals.
  • Dedicated project managers with adequate back up team.

A differentiated offering for your biopharma sponsors

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