DATA CAPTURE

By Deborah Borfitz

Nov. 3, 2008 | Kayentis, a provider of digital pen and paper technology for the clinical trial industry, is strengthening its U.S. presence with an infusion of $8.7 million in cash to hire new technical and sales staff and expand its offices in Philadelphia. The move is in direct response to “high market demand” for its unique paper-based e-trial solution, Clin’Form, which blends the familiarity of pen and paper with the reliability of electronics to capture case report form (CRF) data, says Guillaume Juge, corporate general manager based in the company’s main office in Gif-sur-Yvette, France.

“The beauty of the technology is that it’s EDC [electronic data capture] in the end, making data available on the Web,” says Juge. “But [trial-sponsoring] companies still have paper as source documentation on site.” The U.S. Food and Drug Administration and the European Medicines Agency have yet to fully embrace digital signatures, he adds, and problematic studies in the recent past are apt to make them reluctant to do so in the foreseeable future.

Guillaume Juge

The same technology used to capture CRF data can also be used for electronic patient diaries, which is experiencing rapid uptake because of significant deficiencies with the alternatives, says Juge. Interactive voice response systems require answering questions by telephone. Personal digital assistants are costly and involve training. And paper has protocol compliance problems. Digital-pen-and-paper technology is simple to use and time-stamps diary entries so sponsors know precisely when data was written down.

In the last 18 months, diary-only studies have accounted for six of the 50 trials run by Kayentis, says Juge. The company expects to be running “dozens per year” in the very near future because its application makes “fake” data detectable so that it can be cleansed from the database. It has been estimated that up to 30 percent of data from traditional paper diaries is unusable.

With Clin’Form, an infrared camera in the digital pen reads small gray dots invisibly embedded in the digital paper, capturing data as well as the identity of the person entering it and time of note-taking. Each reusable pen has a unique identifier assigned to a particular investigator, study monitor, or patient that allows them to enter data appropriate to their role, says Juge. The dot pattern was developed by Swedish Anoto Group.

In most cases, data gets transmitted from the digital pen to the study’s sponsor via computer, says Juge. But it is also possible to transmit the data wirelessly via a mobile phone using a digital pen embedded with Bluetooth technology.

Juge says he first came to the U.S. last October to visit technical partner Hewlett-Packard, which developed Clin’Form’s underlying “forms automation system” architecture. In June, Kayentis took office space at Philadelphia’s Science Center, a life sciences incubator. By September, the office had two employees. Guy Maestre, former vice president of strategic planning at Wyeth, serves as Kayentis’ vice president of operations for North America.

The company expects to acquire its first U.S.-based customer this month. Currently, Kayentis serves three major customers: France-based Pierre Fabre and Servier and Switzerland-based Actelion Pharmaceuticals. But in global trials, Clin’Form has been implemented in 40 countries, including the U.S., says Juge. Actelion was the early adopter and does 100 percent of its Phase II and III trials with digital pen and paper. The other two companies also use traditional paper-based CRFs and EDC.

Clin’Form is being used on a more limited basis by pharmaceutical reps to produce sales and sample delivery reports and by bench researchers for note-taking in the lab, says Juge.
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