By Allison Proffitt 

December 3, 2013 | After 17 years in clinical operations, PharmaPros is shifting their focus and changing their name. The company unveiled its new identity – eClinical Insights, Inc. – last week, and a new product today. 

The changes in direction have been a long time coming, Brion Regan, Head of Strategic Development & Partnerships, told Clinical Informatics News on the day of the announcement. Regan, son of PharmaPros founder and CEO Peg Regan, says that the company has a history of evolving as the market has changed.

“In the mid-2000s we started to service the smaller to mid-sized companies... Ultimately what we saw was that when EDC [electronic data capture] hit the market, that was no longer going to be a model that was going to be successful for us. We had really taken on a lot of CRO-type services that [were] outside of our mission.”

In the past several years the clinical trials landscape has shifted to outsourcing and global trials. The technology landscape has become fragmented, said Regan, and the company realized that the technologies it was using internally fit a need in the industry.

In 2009, PharmaPros launched DataFlow Manager. Regan said it was soon clear that technology offerings would be the future for the company. PharmaPros leveraged their existing relationships with CROs and sponsors and began building a portfolio of technology solutions. As consulting projects came to an end, agreements weren’t renewed and new contracts weren’t signed.

The name change, Regan said, signifies the end of a metamorphosis that began with the DataFlow Manager launch.

eClinical Insights is a software company, Regan stressed, not technology enabled by a back-end “army” of busy consultants. There are no custom development services; no bespoke applications.

What the industry needs, Regan said, is a holistic view, technology that’s easy to implement and rapid to configure: operational intelligence, not point solutions.

With the shift in vision comes changes in the company structure and the client portfolio. Regan says that the headcount at eClinical Insights is down by about 40%, though he maintained that many of the company’s employees “converted” and still represent a depth of experience in the industry.

It’s a point that distinguishes eClinical Insights from its new competition, he believes.

“People in our company are not just software developers. We wanted to retain the value of people who have run clinical trials before and who are proficient in technology,” he said. “When software gets developed in a vacuum it can look pretty on the surface, but implementing it in a real clinical trial is a little bit more complex. Having people who have that perspective, who understand what this is really going to look like on the ground… is valuable.”

As for clients, Regan said 30-40% of the company’s services customers have turned into technology customers. He said eClinical Insights is finding the most traction with CROs.

“CROs are probably the companies most affected by the challenges in the industry today… A lot of them might have their own ECD systems or their own technology, but in fact they're only using their technology at best 25% of the time. The rest of the time the sponsor is dictating which systems they want the CROs to use. It’s a very challenging business model,” Regan said.

“There’s not a lot of predictability in what systems they’re going to be using in different trials and different programs. They needed a scalable way to bring data together regardless of what the underlying system is. Our goal is to be able to extract away the complexity of the underlying systems and provide a holistic view in a scalable way.”

Products for a Post-EDC World 

The backbone of eClinical Insights is a platform of tools, all leveraging integrated data. In addition to Dataflow Manager, the company has recently added TrialOps Director. Users will likely start with one product and choose to add on others, Regan said.

“Users aren’t entering a lot of information into our system,” Regan says. Instead, “it’s being automatically derived from source data that’s being integrated and aggregated up into our analytics engine… We’re positive there’s nothing else in the industry that can do this.”

He calls it “post-EDC technology, a step above that transactional, data management technology.”

This week, eClinical Insights added another product: EndPoint Reviewer, an endpoint adjudication system. “For instance,” said Regan, “if it’s a medical device trial or a cardiac trial, there are often medical experts or key opinion leaders who are asked to come in and adjudicate potential safety events in the trial.” 

The exercise, Regan said, can be arduous. “It’s very manual; there are a lot of source documents that are required.” Adjudication typically happens in one room at one time, but EndPoint Reviewer can automate that.

A screenshot of the eClinical Intelligence Platform in use. Image credit: eClinical Insights

The tool mines clinical data in real time, and users can set “triggers” that identify events. “Then the doctors can go online at their leisure and participate in the adjudication. It’s set up so they don’t have to be in the same room to do it.”

The automation is a concept that underpins the whole eClinical Insights platform.

“If there’s information that resides in another system, it’s not going to be entered into our system. It’s going to be leveraged automatically,” Regan said.

The company has built interfaces to all of the leading ECD technologies. Using commercial APIs, eClinical Insights has built a platform that is a “superset of every flavor we’ve ever seen.” The platform is accessing ECD technologies in real time, “and incrementally aggregating and integrating that information.”

“Our philosophy has always been automation,” Regan said. “Even back in the old days when we were developing custom technology, the mantra was, ‘Never repeat the same task twice. Always automate.’”