EDC helps Phase Forward march ahead in 2Q

By Phil Taylor

- Last updated on GMT

Related tags Phase forward Clinical trial Edc

Like many of its peers in the contract clinical research sector, data management specialist Phase Forward put in another bumper financial performance in the second quarter headed by a 30 per cent hike in revenues to $41m.

Operating income rose 42 per cent to $6.4m, with earnings per share of 12 cents that was at the top end of the company’s targets.

Phase Forward, which provides software for electronic data capture (EDC), clinic automation and clinical data management, has benefitted from healthy demand for its products from contract research organisations (CROs), according to CEO Bob Weiler.

Leading the charge was the company’s InForm EDC software, which sales of which advanced 37 per cent to $31m in the quarter, helped by the increasing use of EDC among CROs and other organisations running human subject studies.

A highlight of the quarter was the signing of Charles River Labs as a customer for InForm in its Phase I operations, which came about in no small part because of Phase Forward’s concentration on the outsourced trial sector via its CRO Advantage Program. CROs now account for 19 per cent of total revenues in the quarter, and sales to this sector rose 35 per cent. The firm also expanded its business with ICON, i3 StatProbe, Chiltern International, Omnicare, Veristat and Quintiles.

CROs are big adopters of EDC because of the advantages it can confer in winning business, but the technology seems to be moving firmly into the mainstream, according to Weiler.

One of the key messages from the recent Drug Information Association (DIA) meeting in Boston, he told a conference call, was that “EDC has become accepted, and is increasingly becoming a requirement, in the pharmaceutical space.​”

In previous years the question most often posed at DIA was ‘should we adopt EDC technology?’, but in 2008 that changed to ‘how can we best adopt it’, according to Weiler.

That’s great news for Phase Forward and other EDC suppliers because the clinical trial market remains “robust in terms of trial activity​,” and in turn bodes well for the future performance of the company, he said.

Safety signals future growth

Phase Forward is also well place to benefit from another hot topic in clinical research – safety – said Weiler. The company’s Empirica software suite and safety group in Lincoln will allow it to tap into this emerging trend in data management.

Empirica Signal was launched in the second quarter as a major new release of the company's signal detection and management software formerly known as WebVDME. The data mining and knowledge management tool developed in collaboration with the US Food and Drug Administration (FDA) is designed to provide a powerful environment for detecting and managing safety signals throughout the product life cycle.

Other highlights of the second quarter included the sign-up of new customers such as Genzyme for Phase Forward’s Clinical Trials Signal Detection (CTSD) and WebSDM products for safety monitoring, and an expansion of a contract with Galderma related to Empirica Trace product for adverse event reporting.

Phase Forward also formed an alliance with AG Mednet, a clinical trials imaging network, to integrate its InForm integrated trial management system with AG Mednet's imaging transport network. The result will be a streamlining of the process of transporting images between clinical sites and central reviewers, and should enable trial sponsors to access the status of patient images in real-time.

For the full year 2008, the company is predicting revenues will come in between $167m and $169m.

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