Medical images are an essential part of the story. Capturing disease as it really is, at every stage. Medical imaging is a powerful tool helping accelerate the development of new, innovative medicines. And in every day practice, medical imaging can help provide the right treatment for the right patient at the right time.
With our proprietary software, unique approach and industry-leading knowledge of Imaging Phenomics™, Median’s specialists analyze and manage medical images with unrivalled accuracy, consistency and quality. In our centers of excellence in Europe and the United States, we’re building an exceptional resource for understanding the efficacy of treatments for our partners worldwide.
Our unique proprietary software platform manages end-to-end medical imaging workflow. Our technology extracts standard and novel biomarkers using multiple imaging criteria, providing an unrivalled resource for radiologists and clinicians. Through the use of standardized automated practices we deliver the highest quality standards, preventing human error and reducing results variability, independent of our partners’ location, level of expertise or experience.
Our unique algorithms, developed with top research institutions, enable the detection, diagnosis, and monitoring of disease evolution. Our comprehensive cloud-based clinical imaging applications allow real-time data access at any location. As an advanced software developer we offer flexibility, speed and customization, with no hardware hardcoding restrictions. All this comes together to collect powerful, mineable information linking images to disease evolution and treatment effectiveness. Helping chart more precise treatment decisions and accelerate product development
For many severe or life threatening conditions, such as cancer, imaging biomarkers can quantitatively evaluate disease evolution and the effect of therapy. Biomarkers may be simple, such as the size of a lesion, or highly complex, from the measurement of cancerous lesion volume variations, to specific lesion shape pattern identification or volume assessment of specific organ parts.
Median’s technology plays an invaluable role in this evaluation. We enable accurate, reliable biomarker extraction at the large scales required for drug development trials or wide-scale healthcare programs.
By combining algorithmic image processing, advanced image visualization and cloud-based imaging systems, we guide and support medical image interpretation, while leveraging automation for the large-scale extraction of standard, novel, simple or complex imaging biomarkers.
Automation and Standardization
Median collaborates with a worldwide community of expert radiologists and clinicians to gain key insights into streamlining image interpretation and management processes for both routine radiological use and clinical trial applications. This knowledge allows us to standardize and automate these processes, improving performance, such as reducing intra- and inter-reader variability.
Global Reach and Access
Median’s expertise is at the crossroads of innovative healthcare and information technology. Our core platform allows access to imaging applications from any location worldwide. Our cloud-based technology provides access to imaging data with instant structured reporting while also enforcing best practices and meeting all applicable regulatory requirements. By working seamlessly with existing radiology information and clinical trial management systems our platform enables near real-time data exchange.
iBiopsy® Big Data Platform
Our large-scale imaging, and linking images to disease evolution and treatment effectiveness, provide significant potential for big data applications. Using this approach, our iBiopsy® platform offers the capability to uncover new opportunities to improve both patient care and drug development.
Our imaging biomarker expertise is at the heart of ongoing advances in medicine, helping create a better tomorrow.
Working with biopharmaceutical companies, and leading clinical centers around the world, we are using medical images to identify disease fingerprints, paving the way for new personalized and innovative medicines and improved diagnosis and treatment. Image biomarker analysis using big data analytics has an important role to play in this vision of the future, and we are exploiting this approach with our groundbreaking phenotyping system, iBiopsy.
The exceptional volume of data we can access, combined with our ability to draw meaningful insights, offers our partners a unique capability. We are making impressive progress and constantly broadening the scope of what we can achieve in a wider range of diseases.
We are ideally placed at the heart of the rapidly advancing personalized and precision medicine revolution, where detailed, accurate, quantitative imaging is crucial. It’s here that our unique platform offers new and exciting opportunities for both clinical trials and patient care.
Imaging for Patient care
Median’s proven expertise in developing innovative medical device software products, cleared by regulatory authorities around the world, brings advanced imaging to the patient care market. Our technology provides large-scale deployment, standardization, and automation across healthcare networks, and at the regional and state level offers valuable big data to inform health programs.
Our patient care imaging services offer:
- Technology transfer from research to industrial scale
- Product and service definition and validation by key opinion leaders and leading practitioners
- Design control ensuring safe and effective products
- Regulatory clearance across multiple territories
- Post-market, scientific and medical surveillance
- Efficient training, support, and maintenance
- Scalable, cloud-based IT infrastructure with industry-leading capabilities
- ISO 13485 compliance
Imaging for Clinical Trials
Median is an advanced software developer providing flexibility, speed, and customization based on our customers’ clinical study needs. Our technology has no hardware hardcoded restrictions, ensuring image details precisely map therapeutic efficacy.
Our unique software solution provides expert oversight of our customers’ images, automating and standardizing lesion detection, selection, and measurement, preventing human error and missed lesions, and reducing results variability. Our approach is designed to improve clinical trial cost effectiveness and efficiency.
We leverage our experience, know-how, and technology in each area of clinical development, from regulatory compliance, to project management, data management, quality assurance, quality control, imaging and data science, and information security.
Regulatory Compliance: Our team has extensive practical knowledge of clinical trial regulatory requirements for image management. Our clinical services comply with ICH / GCP guidelines, FDA and EMA regulations, and clinical study protocols. Our technology platform provides standardized, automated therapy response assessments, enforcing applicable ICH / GCP guidelines and regulatory standards.
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 platform provides structured image, disease, and lesion data handling, with the link between images and extracted information maintained throughout the clinical trial. Our automated and standardized processes enforce image management and quality control:
Automated checks of imaging parameters, image quality, and target organs are conducted as early as possible during data collection.
Automatic data coherency checks occur throughout the entire data collection process using Median’s integrated LMS and REM 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 a scalable service.
The spirit of cooperation is found in everything we do. Whether working in clinical trials or patient care and treatment, we share the same single-minded goal. To defeat the diseases that still touch so many lives.
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.
Quality is at our core
Our quality assurance system covers everything we do, from product development to distribution, support, and service. Our customer focused system is built on strong processes combined with continuous improvement.
Our Quality Management System is EN ISO 13485:2012 + AC:2012 and CAN/CSA ISO 13485:2003 certified. Our ISO 13485:2012 accreditation ensures our medical devices and related services consistently meet customer requirements and applicable regulatory requirements.
- Europe: our Lesion Management Solution (LMS) product family is marketed under CE (European conformity) mark class IIa certificate in compliance with European directive 93/42/CEE (updated 2007).
- USA: our LMS-Liver and LMS-Lung/Track are marketed under 510(k) FDA clearance.
- Australian and New Zealand: our LMS software suite is marketed under registrations in the Australian Registry of Therapeutic Products (GTPA), and New-Zealand’s registry of medical devices (NZ Wand database).
Clinical trials operations
Our clinical trial services fully comply with regulatory requirements for clinical development. All our services and standard operating procedures comply with ICH GCP guidelines and relevant clinical study protocols. Our clinical trial management teams are highly experienced with FDA and EMA regulations and our technology platform provides standardized, automated therapy response assessments that enforce applicable ICH GCP and other regulatory requirements.
What we do, we can’t do alone
Since Median’s inception, we have developed strategic partnerships to deliver a seamless service in all fields of our work.
We have built our imaging expertise through long-established collaborations with leading imaging centers and key opinion leaders around the world. Consequently, we have comprehensive and extensive medical imaging interpretation and management experience in both routine radiology and image-based clinical trials. Our expertise is continuously evolving through major collaborations and we recently partnered with the San Antonio-based START organization, which is conducting the world’s largest phase I medical oncology program.
Median is at the heart of innovation in healthcare and information technologies, and we partner with industry leaders to deliver advanced solutions to our customers. We partner with Microsoft to deliver our cloud-based iBiopsy® platform and with Canon to develop new imaging technologies for patient care. In the clinical trials field, we have established collaborations with major Contract Research Organizations (CRO) worldwide, where our imaging solutions complement our partners traditional expertise.