Founded in 2008, Silicon Valley, CA-based MDDX invented a novel platform for research image management with the goal of providing private, searchable online image repositories.
As part of the transaction, MDDX’s image submission technology will become the backbone of Bioclinica’s SMART solution, the company said. SMART, which stands for Submit, Manage, Analyze, Report, and Transfer, is BioClinica’s medical imaging services suite.
“Using our global cloud network, SMART Submit reduces the image transit time from weeks to a matter of minutes,” Dan Gebow PhD MDDX founder and chief designer told Outsourcing-Pharma.com.
“By accelerating transfers within and outside the US, SMART Submit enables new speed records for ‘time to analysis’ for image data,” he said, adding that this is particularly important when screening for the trial requires an imaging endpoint.
“Patient eligibility can be determined by remote readers in under one hour, while the patient is still in the clinic,” Gebow added.
Additionally, the technology screens images for common issues before the images are submitted, cutting down error rates which Gebow said average around 8% – though can range as high as 85% for some trials sites, he explained.
“By screening that ensures the images are from the correct patient, it can reduce medico-legal risk by preventing accidental image mix-ups...which is a strong potential pitfall of working with de-identified data,” Gebow said. “Finally, because corrupt or invalid imaging files are detected before upload, the hospital staff saves hours of hassle in researching and responding to queries that result from unscreened images.”
SMART Submit also stores images online for 20 years, a benefit that Gebow said will result in fewer lost images at the lab or while in transit, as well as immediate confirmation that the imaging test was performed.
“Looking ahead, having a centralized repository of highly structured de-identified image data is the perfect substrate for machine learning technologies to elicit new insights for patient diagnostics and therapies that are beyond the throughput of human core lab readers,” Gebow added.
As per company integration, all MDDX employees will become part of Bioclinica.
“We acquired MDDX because it provides best technology, best practices and the best opportunity to provide non-intrusive, existing workflow self-service capabilities to eliminate waste and rework for our most unique customers ─ the research sites,” Medical Imaging and eHealth Solutions President David Herron told Outsourcing-Pharma.com.
“This is a major leap ahead of traditional solutions where transmission of ‘dirty’ images, slowness, and problems with installing software (old software model vs. cloud) are the norm,” he added.
Medical imaging in clinical trials
Medical imaging is used in clinical trials to monitor safety, assess efficacy, and provide primary, secondary or exploratory endpoints, across most therapeutic areas, Herron explained.
“Unfortunately, many times, the preparation and conduct of imaging is an afterthought in clinical trials and for whatever reason is thought to be an easy part of the study design, implementation and execution. It's essential to prepare for imaging needs and have the necessary processes in place early,” he said.
“For critical therapies without effective treatments, such as Alzheimer’s disease, the role and impact of medical imaging in these trials continues to grow - especially as clinicians and scientists seek to define and treat AD at the earliest stages of disease,” Herron explained.