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.