Pharma, Health IT

eClinicalHealth co-founders on challenge of making remote monitoring for clinical trials manageable

The company headed up patient engagement for Europe’s first remote clinical study to include full electronic informed consent.

 Medicine Doctor Hand WorkingA Scottish technology company is trying to simplify remote clinical trials for pharmaceutical companies and for trial participants.

eClinicalHealth Ltd. makes Clinpal, a patient engagement platform that patients can access on their computers and smartphones. The company headed up patient engagement for Europe’s first remote clinical study to include full electronic informed consent. The 2015 VERKKO study, a Phase IV clinical trial for diabetes, was a collaboration among four-year-old eClinicalHealth, Finnish diabetes technology maker Mendor, French pharma giant Sanofi and British health advertising agency Langland.

Clinpal delivered study materials for directly to patients, who connected the smart, wireless glucose meter to their personal Clinpal accounts. The glucose meters automatically transmitted patients’ readings into the Clinpal system, where they were available for real-time review by the patients and the study site.

The pharma industry has been experimenting with remote patient monitoring for clinical trials for some time, but barriers remain. Chief among them: too much technology for drug companies, trial sites, and participants to manage, according to the co-founders of eClinicalHealth.

Pharma companies routinely provide trial participants with devices to enable remote monitoring. Buying and shipping all those devices gets expensive and time-consuming for sponsors, and cumbersome for patients who already lug around smartphones, tablets and laptops, said Kai Langel, director of patient solutions for eClinicalHealth.

“One of the technical challenges has been the extra load on the sites in particular when they’re doing clinical trials,” added Douglas Bain, the company’s chief technology officer. “It’s almost like the latest, greatest, cool technology to add on top of what’s already there.”

Langel was a wee bit reluctant to lay the entire blame on technology, saying that change management at pharma companies was also a factor. Regulators aren’t the problem, either, according to Langel. eClinicalHealth has found European and U.S. regulators “very supportive,” he said.

eClinicalHealth’s core business is supporting late-stage, traditional clinical trials. The company works with four of the top 10 pharma companies sponsoring trials with 22,000 patients through 1,600 sites in 30 countries, Bain noted. Its goal is to enable more fully remote studies like VERKKO for more companies, despite Brexit. (Bain opposed it, like about half of Britain’s small-business owners.)

“There are many companies out there that are creating point-based solutions,” Bain said. “We’re trying to create a platform for the engagement process.”

Both men worked with electronic clinical trials before co-founding eClinicalHealth. Bain co-founded the European office of Medidata, developer of the clinical trial electronic data capture system Medidata Rave. Langel worked for about a dozen years for Plymouth Meeting, Pennsylvania-based CRF Health, rising to senior director of technical support.

The study primarily served to test Mendor’s 3G-enabled wireless blood glucose meter and glucose profiling technology. eClinicalHealth also used it to evaluate how its web-based platform, Clinpal, performed in recruiting patients, obtaining electronic informed consent, enabling online patient-site communication and capturing patient-reported outcomes and measurements.

Bain declined to to name the top 10 pharma companies it’s working with. “We provide a platform that engages patients in clinical trials,” Bain said. “The methods of engagement and the types of engagement will differ with the trial.”

He added: “We wanted more of a patient-centricity toward the technology we provided. We are working in 50 countries with 22,000-plus patients on the Clinpal platform, and 1,600 clinical sites are using Clinpal.”

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