Jersey City’s TrialScope Making Sure Human Clinical Trials are Compliant and Transparent

 

If you have ever had a loved one in need of a miracle medical intervention, you will admire the work being carried out by TrialScope, a growth-stage startup with about 40 employees in Jersey City.

“TrialScope is a compliance software company for clinical trials,” said CEO Jeff Kozloff.

“Human subject research is being carried out all over the world, and there are two important pieces of information that need to be shared with the public and regulators, based on the law,” he explained.

The first piece of information is how the research will be conducted. That’s called the “protocol registration.” The second piece, and the more important in the interest of good science, is the results of that research, which should be shared with the public, he said. “Whether the results are good or bad, you are always learning from the past.”

Sharing these results is not an easy task, however. “There are 90 different countries with different rules around the world. More than 30 different countries have specific registries for clinical trials. In the United States, the registry is ClinicalTrials.gov, and in Europe, it is the EU Clinical Trials Register (EU-CTR). Our software helps companies that are conducting clinical trials to manage their registration, their results disclosure requirements and their data transparency around the world.”

Five-year-old TrialScope is venture funded, and has raised a total of about $17.6 million, according to TechCrunch. Its most recent investors were Princeton-based Edison Partners and two firms near Philadelphia, NewSpring Capital and Dublin Capital Partners. Kozloff came on board as CEO earlier in 2018, after serving on the company’s board of directors for several years. He is also a founder of two successful healthcare technology companies, HeroLinx (Bryn Mawr, Pa.) and Verilogue (Philadelphia).

The company’s technology was spun out of the global financial advisory firm Deloitte which has offices in Jersey City. Kozloff is very fond of  TrialScope’s Harborside location there. “It really gives us great access to a large talent pool,” he said.

TrialScope is gaining traction, and has a “really fantastic roster of customers,” Kozloff noted. “We have 13 of the top 15 pharmaceutical companies as customers. Collectively, our customers are responsible for 40 percent of all industry trials on ClinicalTrials.gov and the EU-CTR.”

A new offering is the company’s Clinical Trial Transparency Service (CTTS), which develops dedicated clinical trial websites for sponsors. The purpose is to enable the public to find nearby trials through geo-targeting and keyword searching. “It does so in a nice plain-language format, and we are using iconography and graphics to make the information more accessible to those searching,” Kozloff said. “Most people want to find health information online now, but how do you know this is coming from a trusted source? How can you tell the quality of the information?” TrialScope is that trusted source, and the information it provides is certified and presented in an interesting way, he said.

In fact, Kozloff said, his goal as CEO is to extend the vision of the TrialScope platform so that it becomes the one source of truth for validated clinical trial information. “If you are a patient or a family, you need to be able to find authoritative and trustworthy clinical trial information, so you can make a quality treatment decision. If you are a researcher, you might want to build upon the study data that has been collected. If you are an advocacy group, you will want to share this information with your membership. If you are a regulator, you’ll need to know that researchers are following the global rules around registration and disclosure.”

The company’s goal, he said, is to be the one authoritative source that will help its customers, typically pharmaceutical sponsors, “make sure that this private, typically confidential information goes through a review and an approval process internally, and then is shared publicly with as many people who are interested in it as possible.”

Kozloff said that TrialScope has been expanding by partnering with all of its various customer groups and by understanding their needs. It is also extending its reach to academic institutions.

“If you are Johns Hopkins, for example, and you are conducting interventional studies with human subjects, you have to register that protocol and share how you are going to conduct the research. The large pharmaceutical companies are really good at this. However, academia is actually at the other end of the spectrum, with only 20 percent compliance.”

The company is currently hiring, Kozloff told us. “We are moving really quickly and expanding rapidly in the areas of patient engagement and health literacy. And, so, we’d really like to hear from people who are interested in that area, so we can partner with them or hire them onto the team in engineering, sales and product development.”

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