Does Microsoft matter in clinical trials? Is it staring numbly at the start of an era of enterprise-worthy, web-based tools from Google?

Or does Microsoft have unique hardware, application and networking tools that make it a more or less indispensable part of the technological infrastructure of the modern clinical trial? That was an interesting thing to ponder at the annual Drug Information Association (DIA) meeting.

With the publicly traded First Consulting Group (FCG), Microsoft announced a new application that is built on the Microsoft applications and networking foundation.

FirstPoint allows customers to have what has typically only been engineered by customized consulting projects: an industrial-strength, 21 CFR Part 11-compliant environment for Microsoft classics like Word, Outlook and Excel.

Clinical Content Management

FCG hopes that the new product will allow smaller customers to take the plunge toward a more affordable enterprise content management system (CMS) that is appropriate for the life sciences. “We are opening up completely new markets,” says Jeff Klein, FCG’s VP of product development.

Klein calls the new FirstDoc a game-changing event for the company, allowing it to leverage its domain expertise and the Microsoft tools that are used to create study documents throughout the 17-odd years that a new drug may wind its way to the market.

What They Already Use

One of the key pieces of the puzzle, Klein says, is the Microsoft Office SharePoint Server (MOSS), which helps FCG to deliver security, audit trails and other Part 11 necessities for the life sciences. MOSS, for the uninitiated, is Microsoft’s way to share meta data and establish user roles and privileges using the Microsoft technology stack.

There’s no question that FCG hopes to take advantage of the comfort users have with Microsoft applications. “One of the key differentiators of the solution is that it is driven from a Microsoft user experience,” says Klein. “Office is the tool that users use. I think it’s almost impossible to compete with the power of end users at their desktops.”

High Demand

Nigel Whitehead, president of FCG’s life sciences group, says the company polled customers on the idea of adapting its tools to the Microsoft platform. The response was overwhelming.“The reasons were so positive that not to have brought this to market would have hurt us with our client base to some extent,” says Whitehead.

Whitehead notes that the cost and complexity of many large content management systems are prohibitive for some customers. Such systems can be daunting to end users who just want to open a colleague’s spreadsheet.

The new product will be significantly easier to deploy and less expensive for a tier of smaller customers than FCG is reaching with its heavy-iron FirstDoc product now.

Two Solutions

FCG’s flagship product, FirstDoc, has shared its logic and intellectual inheritance into its kid brother, the web-based FirstPoint solution.

The new FirstPoint product incorporates FirstDoc’s document types, common work flows, and security arrangements. The system has extensive functionality around collecting the raw data across the life cycle of a drug, not to mention managing the generation of the electronic common technical document (eCTD) to be submitted to regulators.

The Microsoft Platform

Microsoft has been coming to the Drug Information Association for a few years. It has selectively attempted to help customers who have already invested in the company’s applications and networking tools.

Paul Mattes, industry solutions director at Microsoft, says FCG is the dominant document management system in the industry. (Companies like Mission3 and Octagon Research might quibble with that.)

“We’ve been getting our hands around the key issues and the pain points in the market,” says Mattes. “We started working with partners to ask what are the key things to have a powerful solution?”

Findability

As an example of what MOSS can enable, Mattes points to the ability to not just find a document, but to find the right document, meaning the one that was most recently updated or approved by the organization—not a bewildering list of documents with slightly different versions of the same name that Google Desktop might present.

Office, Secured

“MOSS has an integrated search feature to allow users to find information much more rapidly than they have before,” Mattes says. “All the folks in the life sciences are drowning in information and documents. What we’re talking about is the ability to get down to a single version of the corporate truth. You want that to be as intuitive and as rapid as possible.”

The key message, Mattes says, is that Microsoft is a foundation on which other domain-specific tools for industry can be built. “Office is a platform,” Mattes says. “It has evolved to really being an extensible development platform that is highly inter-operable with other applications in the IT portfolio.”

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