MORRISVILLE, N.C. — In what executives are calling the biggest deal of the firm’s history, etrials Worldwide is launching a massive clinical trial utilizing wireless technology for one of the world’s largest pharmaceutical firms.

etrials is one of the world’s pacesetters in the use of online and wireless data gathering for drug testing with its “eDiary” and “eClinical” software.

Profitable for two consecutive quarters, the Morrisville firm picked up additional momentum with the new contract announced this week.

etrials can’t identify the client other than as a “top 10 global pharmaceutical company”, can’t identify the drug it is testing and can’t disclose financial details of the contract. But the company can disclose enough details to describe the far-reaching scope of the project.

“This particular deployment is a big deal,” said David Levin, etrials’ vice president of marketing. “We believe it is the largest in the world to date to use wireless technology, but we can’t prove that. It certainly is the biggest deal in company history.”

Pharmaceutical and biotech companies are moving to embrace eClinical applications for costly, long drug trials. Among the benefits as touted by firms such as etrials is a faster means of collecting data rather than relying on paper. (See related story, , about the industry trend.)

etrials (NASDAQ: ETWC) has embraced EDC across the spectrum of data gathering, from e-diaries to voice capture to overall trial management. The company has worked with 15 of the top 20 pharmaceutical firms and announced in November contracts with two major clients.

The newest contract will require etrials to deploy 4,700 wireless devices for the gathering of patient data. Both etrials’ office in Morrisville and in the United Kingdom will be involved.

Patients will be trained to answer questions through wireless equipped personal data assistants (Dell Axim X51s). Data will be transmitted over cellular networks, including Cingular and British Telecom.

Patients will be trained to use both eDiary and interactive voice response technology as provided by etrials.

“Almost 5,000 subjects around the world will be using handheld computers to report outcomes that are wired to a central server so the sponsoring pharmaceutical firm is getting real time information,” Levin said.

“This is a direct comparison to paper. It could take months before a sponsoring organization could get information back and begin to make decisions.

“If you think of why pharmaceutical firms conduct clinical trials to begin with, it’s to collect data. If you can get the information in an integrated fashion to the people who need to make the decisions as quickly as possible, that’s a real win.”

The contract covers a Phase III trial in which the pharmaceutical firm wants to determine the safety and tolerability of its proposed vaccine.

etrials is also responsible by management and maintenance of patients enrolled in the trial. More than 420 sites are involved in Europe and the U.S. etrials is also responsible for training, language translation, and technical support.

John Clines, etrials’ chief executive officer, was traveling and unavailable for comment. However, in a statement about the new contract, he said its scope and complexity demonstrated the growing confidence pharmaceutical firms have in both EDC and etrials.

“The scale of this deployment further demonstrates that the top global pharmaceutical companies are selecting our eClinical solutions for their most complex and comprehensive clinical studies,” Cline said. “Our proven software and solutions have again shown that our customers can deploy large scale trials utilizing multiple solutions while rapidly integrating data into one central database, a critical advantage in this study and as sponsors scale their multi-site trial investigations.”

To date, etrials has been involved in more than 900 clinical trials, working with pharmaceutical, biotech and medical device firms.

Because of growth in business over the past year, etrials has increased its headcount by 15 percent, to more than 120 employees. Over the next year, the company plans to add another 10 percent.

“We have active positions available,” Levin said, “primarily in our operations group.”

For the third quarter of this year, etrials reported $4.4 million in revenues, an increase of 40 percent over the same quarter in 2005, and a profit of $391,487. In the second quarter, etrials reported a profit of $60,000. It currently has more than 30 customers, compared to eight in 2005.