EDC upstart CTEP tackles Ph4 market

Dublin-based Clinical Trial EndPoint (CTEP) has found its sweet spot. With Oracle ($ORCL) glomming up big chunks of the clinical trials market for electronic data capture (EDC) software, smaller players seek out specialty areas that enable them to compete with the majors. For CTEP, that specialty is Phase IV or post-approval studies.

The 12-person firm recently released a web-based data-capture product for the post-approval market called RealWorld EDC, Siliconrepublic.com reported. Used to record data on drugs that have been recently approved, the firm's technology has attracted recent deals from large drug companies Novartis ($NVS) and Astellas Pharma, the company tells the online publication. And the firm is working with a total 15 drugmakers in Ireland and the rest of Europe.

CTEP appears to have designed its EDC system to address some of the challenges of the post-approval landscape. Rather than trained clinical trials workers, the users of such software in the Phase IV arena are often clinicians who are observing the effects of approved drugs on patients in the real world setting and recording what they see. This demands that the software be easy and convenient to use. To meet these challenges, CTEP's software is centrally hosted an available to users via the Internet on the iPhone and iPad.

The name of the game in the post-approval arena is spotting safety issues of products as quickly as possible. Greater use of information technology helps collect data rapidly and can be analyzed to spot issues that could trigger actions such drug recalls. Outcome Sciences in the Boston area and other groups have focused their technology and services on the Phase IV market, which has been growing along with greater demands on developers to ensure the safety of products after they are cleared for marketing.

"We would see ourselves as stealing a lead in the late-phase segment," CETP Managing Director Stephen Dorman told Siliconrepublic.com. "We're the only company that has specifically developed our software for the post-release space."

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