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Oracle Discusses Agenda for Clinical Trials

By Mark D. Uehling

March 14, 2006 | The news from Oracle is largely speculation about its “Fusion” project, middleware that is still under development. Oracle promises that Fusion will unite all of the acquired tools in its portfolio. Those include Siebel, PeopleSoft, and J.D. Edwards, all part of a $19 billion acquisition binge. In surprising ways, Fusion is helping to shape Oracle’s strategy in the clinical trial space.

The unanswerable question across the company’s user base, however, is the same: How significantly will Oracle’s new applications have to be rewritten to fit under the company umbrella? Will such changes make the biggest, most bureaucratic Oracle customers cringe or smile?

Oracle’s vision in the life sciences is as eloquent as they come. With the industry’s preferred database and a suite of applications designed for clinical trials, Oracle executives have their hands full.

Ed Lengyel, Oracle’s senior director of product strategy, says it was premature to offer any predictions about how the Siebel acquisition will affect Oracle Clinical. Siebel Clinical is a tool for customer relations management, but it’s possible to imagine it being put to other tasks. “We’re still digesting it,” Lengyel says of Siebel. “We’re getting to understand better the products they have. They have very, very nice analytics.”

Lengyel mentions the forthcoming Clinical Data Repository (CDR) product from Oracle. CDR is a validated data warehouse designed specifically for the pharmaceutical industry. CDR has been in development for years. Mike Grossman, Oracle’s director of product management, explains that Oracle’s CDR would be appropriate for companies of any size. “You can get a return on investment from a small, medium-size, or large company,” he says.

Unwieldy Beasts
Some regard data repositories as foundational — the bedrock for astute, real-time decisions in pharma. Others scoff, comparing data warehouses to Hummers: extravagant, unwieldy beasts inappropriate for trips to Starbucks. Oracle’s Mike Grossman acknowledges that some data repositories are not driven on a daily basis. “People stop using the repository because it’s out of sync,” he concedes. Some repositories (federated or not) become obsolete after glorious debuts, especially if new types of information or updated data cannot easily be injected into them.

Oracle’s vision for CDR is still under wraps. But pieces of the strategy have been discussed in public. It’s clear Oracle hopes to simplify the mundane infrastructure aspects of a data repository — security, audit trails, a graphical user interface, and the like. But the nature of the information flowing into it will be at the customer’s discretion. Oracle is stressing the importance of process in the design of the repository. To support that, its technology will include new data “loaders” that can be individually validated without affecting the whole repository. And the company will supply ways to freshen up the repository with automatic and ad hoc “triggers” to keep the data current via prescheduled and manual updates.

Ideally, Oracle believes, ordinary mortals in clinical and nonclinical jobs should be able to use a data repository regularly. If it contained the most recent data, line employees could well regard their repository as indispensable.

Grossman is cordial about his next point. But he observes that data at the highest levels of certain drug companies are not necessarily in sync with the data in the trenches. There’s a gap. If users really accessed a repository more routinely, and the repository contained crisp intelligence, some of that should be visible all the way up the command chain.

It’s certainly true that getting one’s arms around, say, patient recruitment milestones often requires information from more than one source. And so we asked Grossman about Oracle’s enhancements to two symbiotic clinical trial management systems (CTMS): TrialMinder and SiteMinder. The company has not overdone the marketing of these products. Grossman assures us the applications — one designed for sponsors of trials, the other for clinical sites — are available and interoperable with other Oracle pharmaceutical applications.

“We have some offline reporting and feedback capability that is being added,” Grossman says of a forthcoming patch to TrialMinder and SiteMinder. “A lot of times, when monitors go out, they may not have connectivity inside the firewall. We allow them to download Adobe PDF reports that are forms. They can fill them out, do their visit, go back to headquarters, and upload them.”

Gentle Migration
Oracle’s Andy Alasso, director of product management, is responsible for high-profile offerings such as Oracle Clinical as well as the company’s thesaurus and drug safety systems. Oracle has always done user testing, but apparently it has intensified of late, especially with the company’s electronic data capture (EDC) product, called RDC, which is also in Alasso’s domain. “We’re working on a release that we’re calling RDC OnSite,” Alasso notes. “This interface is intended to show them their patient list upon login. We’re trying to streamline the experience of our customers.” Look for OnSite later this year. It could ease the lives of people who never liked what Pfizer is said to have stipulated — RDC’s front end, which relies on Adobe PDF forms.

That brings us back to the Fusion middleware: It’s a gentle migration away from proprietary Oracle Forms and toward generic HTML and Java-based ways to enter data. This is a companywide migration for Oracle, but it’s hitting the pharmaceutical suite, too. Says Alasso: “The publicly stated position for Oracle, as we embark on our Fusion platform, is to move away from the proprietary Oracle Forms environment.”

In a rare tip of the hat to a competitor, Alasso alludes to a recent acquisition by Phase Forward: Lincoln Technologies builds a variety of analytics (some Web-based) for drug safety; its prowess in the niche is respected at the FDA. Alasso says the company is endeavoring to give customers similar capabilities within Oracle. “We are definitely addressing that functionality within our application,” Alasso says.

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