Bioclinica, a provider of scientific-enabled Medical Imaging, eHealth and patient-centric solutions supporting clinical research, has acquired Silicon Valley-based MDDX Research & Informatics, adding advanced cloud research image management and submission technologies to its extensive suite of eHealth solutions.
With the acquisition comes MDDX’s best-in-class, cloud-based image submission technology, which will become the backbone of Bioclinica’s SMART solution. SMART, which stands for Submit, Manage, Analyze, Report, and Transfer, is a robust suite of centralized medical imaging services designed to manage the complex imaging process from image receipt and analysis to regulatory submission. This SMART Submit innovation will make the image submission process easier, faster, and cleaner for clinical research sites anywhere around the globe – leading to higher-quality data for submissions and better outcomes.
Bioclinica President and CEO John Hubbard, Ph.D., said, “Combining the MDDX technology suite with Bioclinica, including advanced cloud research image management and services, is a perfect match, especially for sponsors who want the assurance that the critical medical imaging component of a clinical trial is managed efficiently, accurately, and reliably, regardless of where the trial is held in the world.”
Dr. Hubbard continued, “Making the sophisticated and proven MDDX technology the backbone of our medical image submission solution means that Bioclinica customers can now rely on a unique combination of the industry’s most experienced medical imaging professionals and the most advanced imaging technologies.”
"Harpoon Medical has relied on MDDX since the inception of our clinical protocols in Europe. The reliability and ease of the system interface has allowed our research sites to quickly upload images so that review for treatment decisions and core lab adjudications can be accomplished efficiently,” said Robert Villanueva, Director of Clinical Research, Harpoon Medical. “We are excited they’ve joined the Bioclinica family and look forward to seeing both teams leverage their respective resources to simplify and accelerate clinical trials.”
MDDX founder and chief designer Dan Gebow, Ph.D., joined by his full team of image data technologists and software engineers, will head up research image management at Bioclinica. Gebow is known as an industry disruptor, bringing advancements with image quality control, large file transport and global cloud-based high-speed transmission. Gebow said, “Bioclinica has been the hands-down industry leader in imaging and scientific integrity for clinical trials. Together with MDDX’s leading-edge technologies we will accelerate the pace of disease discovery, treatment and medical devices while opening new possibilities for cross-trial image data insights.”
The FDA 21 CFR Part 11 compliant MDDX platform was recognized earlier this year with a Pharma Tech Outlook ‘Top 10 Providers of CDM solutions, 2017’ award. The platform, powered by artificial intelligence and machine-learning technologies, integrated over 1,500 screening and de-identification rules to detect image issues and automatically de-identify any standard image type. An online hosting environment brings clients the added benefits of real-time access to imaging data complete with audit trail transparency.
Medical Imaging & eHealth Solutions President David Herron said, “This exciting acquisition brings us the gold-standard platform for collecting, screening, storing, and sending pristine and HIPAAcompliant image data to Bioclinica.” The result is a holistic service for rapid submission of images from research sites direct to the image readers in a matter of minutes.
The application uses proprietary algorithms and technology and is backed by a de-identification guarantee, a zero percent error rate for images that passes their image Quality Control, and 20-year online storage to exceed even the most stringent record-retention requirements. The cloud-based system has data centers for global coverage anywhere clinical trials or postmarket surveillance projects are performed-so that upload and download speeds is never a problem for users.
Moreover, with automated compliance and standardization, the new SMART Submit will completely remove the variability of improper image de-identification and mislabeling to ensure accuracy, conformance, and efficiency of image analysis. Proprietary algorithms are used to screen image data before submission, greatly reducing downstream queries and other issues. All images are processed to meet DICOM conformance standards and to satisfy health-authority, security, and privacy regulations worldwide. To ensure traceability, unalterable and searchable audit trails record the data stream of all events.
Herron commented, “The MDDX acquisition further solidifies Bioclinica’s position as the premier global provider of research image technology and services to sponsors and Clinical Research Organizations, and the only large independent medical imaging core lab with the industry’s most advanced in-house image transfer and workflow capability.”