Microsoft Word documents and Excel spreadsheets are as ubiquitous in the life sciences as in any other industry.

In the clinical trial space, the question is: does having trial-related data in non-compliant, non-validated applications present an opportunity or a risk? Can Microsoft programs co-exist or support clinical-trial-specific applications? Or should they be banished in the name of having an entire organization working inside one system—and not cutting and pasting data from sundry other programs? Your guess is as good as ours.

But we were impressed by a case history on a clinical and research data system for the National Epilepsy Research Initiative (which doesn’t appear to have a website). In a year, its system was built using Microsoft tools and help from TAKE Solutions. It can handle genomic data, patient data, site data. The works.

MS Clinical?

Readers who may believe that Microsoft is playing on the margins of the industry should ask themselves about the epilepsy project’s participant activity tracker, which “is used to facilitate electronic data capture of all participant visits and schedule of events (e.g. questionnaires, specimen collection) across all participant activities. The participant activity tracker is the central application for managing patient visits and collecting phenotypic data on patients.” Here’s the white paper.

We caught up with Microsoft at the 2008 Drug Information Association conference in Boston. The company stressed it is leveraging XML and its own networking tools, such as Sharepoint, to allow clinical trials to capitalize on the familiarity that ordinary corporate mortals have with Microsoft programs.

Network Effects

“Microsoft wants to play nice in the sandbox and can, more so than other large vendors in the space,” says Les Jordan, Microsoft’s industry technology strategist in the life sciences. “We focus on open standards and open architecture, all the web services.” His unstated (and correct) insinuation is that some proprietary clinical data formats can inhibit both sharing and productivity.

Indeed, Jordan is somewhat circumspect about exactly how far the industry has come in its efforts to transfer and use electronic data and connect mission-critical systems used in the clinical trial industry. “There can be no movement because the technologies are too dissimilar,” he says.

Jordan notes that most knowledge workers in the business world spend 75 percent of their time inside the Office suite. Assuming he’s right, it’s not clear whether the same statistic holds in clinical research, where different functional roles tend to have their own favorite software package (or a few of them).

Picking Partners

It’s true that Microsoft’s platform is becoming a bit more open, mostly after litigation in Europe or the threat of it. (Here’s a link to a recent ArsTechnica story.) The other trend is that Microsoft is working with smaller firms to create an electronic framework in which data from Microsoft applications can be easily grabbed and manipulated by industry-specific tools.

The jargon is “Office Business Application,” or OBA, and we counted a number of life-science firms on the relevant Microsoft web page recently. Names familiar to us included Arx, Intrasphere, First Point, Good Products, Nextdocs and Qumas.

“The information workers in this industry live in Office,” notes Michael Naimoli, director of life science industry solutions at Microsoft. “They live in Outlook.” He says Microsoft has 900 people working on health care and pharma-related topics.

Naimoli formerly worked at Merck and SmithKline Beecham. His argument for Microsoft partners (and sponsors considering those vendors) is simple. Microsoft’s sheer size can address concerns about the strength of some of its partners. “One perception is that you’re taking a risk with the partner community,” he says. “We are some broad shoulders that these partners can stand upon.”

CTMS Alliance

As an example, Microsoft used the DIA show to issue an announcement with a Florida company called In.vision, which specializes in managing XML documents in regulated industries. The news release states that the combination of the In.vision technology and Microsoft Word creates “templates that encapsulate corporate business rules, thus allowing authors to create and reuse instructions, examples, and boilerplate text within templates that are tailored to the organization; [and] ensure that proper document style and structure is followed.”

Transenda is another example of a company working with Microsoft, and Microsoft’s Jordan notes that the clinical trial management system firm has received guidance on where Microsoft’s technology is going and on how Transenda is likely to fit into that landscape. The Transenda application is web-based but can easily extract data from Excel and use a nifty web-based calendar for scheduling patients. We’ll have a separate report on Transenda’s system soon.