By Benjamin Ross

June 4, 2018 | Bioclinica is providing a service the company’s VP of Imaging Technology, Dan Gebow, calls an “alternative to FedEx.”

The service, a medical imaging platform called SMART (Submit, Manage, Analyze, Report, and Transfer), collects, stores, screens, and distributes pristine, HIPAA-compliant image data for clinical trials through a web browser. 

Bioclinica’s service caught the attention of judges during the 2018 Clinical Informatics News Best Practices Awards competition, earning the company the Best Practices Award for Patient Data Management at the Summit for Clinical Ops Executives, SCOPE, in February.

SMART serves as a conduit in the imaging process from image receipt and analysis to regulatory submission. During that process, 150 different quality checks occur that clean up the image parameters, checking off the box of various qualifiers (such as: is this the correct image, a duplicate image, etc.?).

“If left to their own devices, such as shipping CDs or using Dropbox, the query rate (meaning the number of times images are submitted with some type of issue) averages somewhere around 60-64%,” Gebow tells Clinical Informatics News. “And so by using this screening before upload, [Bioclinica] is able to reduce that query rate to 30%.”

There are two main advantages to SMART: reliability and durability.

“We store images upwards of 25 years depending on the trial requirements,” Gebow says. “The reason that’s important is that every different country and every different sponsor has their own record retention requirements saying how long they’re asked to hold on to medical images or any sort of document.”

Concordantly, Gebow says that Bioclinica separates itself from other clinical research solutions companies who will charge significant amounts for retrieval of those stored images. This is because of the sheer size of particular files (sometimes terabytes of data, according to Gebow) and because they are not immediately accessible images.

“So if 10 years from now the FDA comes and wants to audit 100 selected images for re-review, it can take weeks or months to try to retrieve them from one of the archives,” says Gebow. 

The turnaround time is also quicker than standard practices, Gebow says. 95% of the quality checks take place before the user completes the submission process, with the remaining 5% occurring while the data is on Bioclinica’s server.

The industry standard for electronic submission, according to Gebow, is to have images submitted either through an application that needs to install on the hospital network, which requires a lot of bureaucracy and red tape, or through outdated Java Software, which requires downloads and updates every few weeks.

“Java in particular has been an industry standard for 7 or 8 years,” Gebow told Clinical Informatics News. “There’s a pain of having to constantly be on top of updates, and Java has also been deemed insecure by the majority of modern hospital information systems.”

Bioclinica’s solution will work with any web browser, functioning through Amazon Web Service’s (AWS) global cloud network. This is crucial, Gebow says, when considering the vast amounts of regulations and pending regulations that impact the data industry.

Regulations like the European Union’s General Data Protection Regulation (GDPR) have set many companies in a panic about what to do with their clients’ data and how to properly store it.

“EU Data Protection and US HIPAA regulations carry stiff penalties or criminal charges for accidental or intentional disclosure of identifiable patient health information,” Bioclinica wrote in their Best Practices entry, “making de-identification of medical images a critical step in de-risking a clinical trial as far as data breach for the sponsor, CRO and/or investigators.”

Bioclinica has had the advantage of being one step ahead, Gebow says. “We’ve been [de-identifying patient’s information] for going on 6 years, long before the regulations were enforced,” Gebow says. “The reason we do that is because we’re building a 20-year repository, and if you consider the patient identifiers as akin to radioactive material, you do not want any of your repository to be a potential liability for lawsuits and/or criminal activities.”

Business has been good for Bioclinica, adding a dozen new trials to their portfolio every week. Gebow says their cloud-based approach prepares the company for the workload.

“While other companies are still working out of servers in their backrooms, we’ve been able to scale really quickly on [AWS], which allows infinite scalability,” says Gebow. “If we get a big push of images coming in, say around Christmas or the Fourth of July, with a flick of a switch we get to uptick the number of virtual servers that are accepting those images. That type of scalability and elasticity is something no one else does. I don’t think they’ve even tiptoed into the area. The complexity of the cloud is a barrier to most people.”