Whatever happened to Oracle Clinical, the database firm’s flagship application for clinical data management? It’s still there. As we noted a few days ago on this site, some Oracle customers in the sponsor and contract research organization (CRO) community are starting to acknowledge their usage of the company’s technology.

But the company doesn’t make as much noise as its competitors. Some in the industry no longer believe they need a massive, central clinical data management system. In another key market, electronic data capture, Oracle’s technology has been outflanked by smaller, more agile companies that it must have formerly viewed as irksome tse-tse flies.

Fair or not, the perception in the industry is that Oracle allowed Pfizer to drive the design of its EDC solution to such a degree that few other sponsor companies or CROs wanted anything to do with it.

At the corporate level, the database firm has spent several years digesting $25 billion in acquisitions in a global race for size with Germany’s SAP. Even after that spree, Oracle is one of a select number of top-tier technology firms with a pristine financial profile. Just in case any other companies catch the eye of CEO, cofounder and yachtsman Larry Ellison, Oracle has $10.7 billion in cash in the bank.

A Different Game

Not long ago, Oracle’s Patti Devereux Gaves rang us up to explain that the company is hardly dozing. She’s based in Connecticut; her title is senior director of product strategy. Gaves says the health care and life sciences group at Oracle has been busily building for the future, and is not ceding any territory to any competitor on any front. “We’ll be #1 or #2 soon,” she says. “We’re not ruling anything out.”

Gaves notes that the company already has most of the elements of an eclinical portfolio—including EDC, data management, safety, coding, data warehouse, clinical trial management—and is considering what to do about those it lacks. It sounds like buying, building and partnering to fill out its offerings are all under consideration.

With time at Medidata and Pfizer under her belt, Gaves has a uniquely well-qualified background with which to pitch in on any Oracle effort to flex its muscles. One of her early jobs was with the database firm; she returned to the company in 2008 to help it chart a sort of re-entry to the still-thriving eclinical battlefield. At this point, at the end of the first decade of the 21st century, Gaves does not see the game as being purely about EDC.

Big trials, she suggests, pose larger technical challenges than just gathering clinical data. “I think it will be a different game,” says Gaves. “We’re talking about a full health science and clinical development safety suite. There will be options around which applications to use.”

On the EDC front, she acknowledges that an early version of the company’s solution may have been a bit too dependent on the Acrobat PDF interface from Adobe. But subsequent updates have freshened the product, adding a more traditional web-only browser interface. Oracle’s EDC software continues to be seamlessly integrated with a full-fledged clinical data management system (CDMS) in ways that other EDC solutions are not. Big pharma understands the ongoing relevance of a full-featured CDMS, Gaves says.

New Unit

Without tipping her hand, Gaves says there are discussions at Oracle which will convince the industry that the company is serious about offering modern, up-to-date eclinical tools. “There are things that are going on here. They’re interesting,” she says.

Last June, she alerted us, Oracle created a dedicated business unit for the life sciences, something that the Redwood Shores, California company doesn’t do casually. (Here’s a release on the topic.) The new group will have additional resources and a bit of independence from the usual corporate encumbrances. (Other business units at Oracle are devoted to financial services, retail stores and insurance.)

Business unit status raises the stakes. Within Oracle, there’s an expectation that the unit will be first in its industry niche. (Any such assertion about its dominance of eclinical or even EDC would be vigorously contested by Oracle’s competitors.) Says Gaves: “With that attention comes opportunity and risk and expectation. We’ve seen a lot of momentum in terms of strategic deals. It’s an extremely busy road map.”

Gaves reports to Nick Giannasi, who is leading the product strategy of the business unit and a veteran of the health care division of take-no-prisoners GE. Although not typical in the eclinical space at the moment, the ability to address health care and industry-sponsored pharmaceutical research in the same product suite could be an advantage for Oracle in an era in which some customers want more all-encompassing solutions that touch both worlds. The company’s core strength in databases and their accessories remains razor-sharp.

Analytics Push

An example. Oracle had a clinical data repository that limped along for a while, not so much on its merits but because of perceptions that no one in any industry really ever gets much done with a data warehouse. But then a few life science customers started using Oracle’s product, and it worked. “Some customers use it to automate clinical study reports. It’s starting to take off. There are five customers up on it now and lots of interest,” Gaves reports.

She offered a hint about another initiative for 2009: business intelligence. “That is the next product we’re working on,” Gaves says. Oracle did buy Hyperion and Siebel during its acquisition spree but has also put its own business intelligence mojo into the new product’s functionality.

Gaves is not arrogant. “We did lose market share,” she says. But she believes the work Oracle was doing on its pharmaceutical-industry product suite leaves it well-positioned for the next few years. Says Gaves: “There are some positive things coming out of the investments we made in that time. We’re here, we’re curious.”