Firm’s software eases development of medical advancements

Keep it simple.

That was the advice doctors, nurses and others gave to John Schwope in his development of a software solution to the complexity of clinical trials.

The result: Simplified Clinical Data Systems, which he incorporated in 2003, which has developed a way to help compress and simplify the time table of getting a new medically related product through the development and trial stages and into production and public use.

“We’ve stuck to that,” says Schwope. “One of the best selling points of our product is that it’s simple and easy to use for these sites, for the doctors and for the nurses. They’re the most critical component in this process.”

Simplified Clinical, based in Portsmouth, is a software as a service company, which delivers software and applications over the internet as a service, rather than an installation. Privately held, the company specializes in the medical and biotech field, helping them bring products and processes to market by way of clinical trials.

“Compared to the old days, when you used to buy software, you used to buy a box, and it had floppy disks or CDs or whatever. You took that and you installed it either on your PC or on a server in your own facility,” he says. “In this case, software as a service, you don’t buy any boxes of anything. We run that software application on our servers. And in this case, they’re actually Microsoft’s servers. And now people just log in and use our software. We provide software as a service as opposed to software in a box.”

It keeps its operation simple as well: It has six employees that operate in a hybrid at home-at work environment on Fleet Street in downtown Portsmouth.

Clinical trials are involved, sometimes rigorous exercises that are required before a medical product, process, medication or vaccine gets government approval. It is a process that used to depend on paper.

“The clinical trial process was so laden with paper,” says Schwope, “and that whole cycle time of completing a clinical trial took forever because it was so paper-intensive.”

As an example, he cites the experience he had before creation of his company.

He was working on a contract basis for Boston Scientific, which developing a stent — a tiny tube that is placed in the coronary arteries to maintain blood flow in the treatment of heart disease. Clinical trials for the product were taking place at Massachusetts General Hospital in Boston.

Each patient who agreed to be part of the trial generated pages and pages of paperwork that then had to be FedExed from the hospital to Boston Scientific, where the information was then typed into a database. And to make sure there weren’t any input errors — such as the simple transposition of two numbers, say — a second individual was also keying in the same information into the database.

“Then they run a comparison of the first pass and the second pass to see if there are any discrepancies. If there are, now they have to go get the paper and get the two different people and figure out which one is correct,” he says.

From print to digital

Schwope’s background is in business forms.

“I used to sell business forms to banks and insurance companies by the pallet load,” he says. “Part of that work was working with different people in their company: How do you want to design a form? What information do you need to capture on the form? Who does it go to next? It was workflow, but the old-fashioned way.”

He tried to sell his employer, a printer, on the idea of electronic forms but was rebuffed. Schwope recalls his boss saying, “’We aren’t in the software business; we’re in the printing business,’ and it didn’t make sense for the company to get involved in that.”

He struck out on his own in the move from print to digital.

It was during his work as an independent contractor in Boston Scientific’s IT department that his idea of digital forms gained some traction.

“A woman came down from their clinical operations group and said to the guy I was working for:

‘We want to start trying to capture some of our data electronically, instead of just using all these paper forms.’ So the guy I was working for said: ‘Go talk to that guy over there, he does these electronic forms things.’”

Schwope visited clinical trial sites on behalf of Boston Scientific as he developed and refined his idea, and it was the goal of keeping it simple that was uppermost in his mind.

“The one thing that all these sites said to me was:

‘Please just keep it simple. I’m a nurse. I got 15 things waiting for me to do. This guy’s a cardiac surgeon. He’s got other things to do,’” says Schwope “They said: ‘We really don’t care about your system. We just want to get in, enter the information and get out.’ When they’re doing these clinical trials, this is just extra work for the physician and his study coordinator. This is just extra work for them. So they said: ‘Please just keep it simple.’”

Global footprint

In general, according to Schwope, his Simplified Clinical digital applications can halve the clinical trial timeline compared to the analog days of paper.

The speed of trials came prominently into play in the response to fast-spreading Covid-19 infections in 2020. Simplified Clinical’s applications were used in the development of a Covid-test kit from a prominent firm that Schwope does not have permission to name.

“As multiple new studies were quickly launched in the U.S. and EU, Simplified Clinical ensured the critically important emergency use authorization data was collected, cleaned and available for meaningful statistical analysis,” Schwope’s company says in a statement. “Simplified Clinical’s efforts helped this client obtain necessary FDA approvals in record time — and before their competitors.”

Today, Boston Scientific is a client, and Schwope says his company is involved with OssDsign, a Swedish company specializing in bone replacement technologies. OssDsign is currently sitetesting a product called Catalyst, an innovative synthetic bone graft used to help promote bone growth in spinal fusions.

Schwope says Simplified Clinical’s use of Microsoft Azure has given the company an ability to offer its services globally. Azure is a cloud computing service operated by Microsoft for application management via Microsoft-managed data centers. That means Simplified Clinical doesn’t have to manage its own servers. Microsoft takes care of all that in a regulated fashion that satisfies FDA security requirements for clinical trials.

“It now gave us that ability to compete on an international basis without that gigantic investment,” he says. “So we compete with these big competitors. And we’re just little Simplified Clinical Data Systems. But we’ve got the footprint now with Microsoft. That was a big step forward for us.”

“We will continue to leverage Microsoft’s Cloud for Healthcare in order to be able to offer our clients future advances in clinical research through the use of their AI/machine learning tools, Real World Evidence through FHIR, and mobile device connectivity using IoT (internet of things) data collection tools,” says Schwope.