In the movies, scientists scour databases to find what they need in a few keystrokes. In the real world, it’s surprising just how limited and narrow most clinical trial databases are. They hold the data from a single trial, a single type of lab equipment. Connecting one database to something else requires Herculean effort, both politically and technically, within most companies. It’s pathetic in 2007.

Waban Software has a different vision for clinical databases. The company can tie together toxicology and microarray data, clinical trial data and generic clinical data, biomarkers and pharmacoeconomic data and anything else that’s in a customers’ electronic cupboard. Uniting discovery and clinical data is, frankly, too lofty a challenge for some companies in the industry.

Thinking Out Of The Box

Waban says its stronghold was in systems for biological sample banking and tracking as that became more important. “We are well positioned and pretty much the leader in that space,” says Pratap Malik, Waban’s VP of corporate strategy. As the same samples were archived, the data locked away for future uses, the company realized that it would have to help customers in the clinical arena as well as the drug discovery space.

Says Malik: “These tools are transitioning into the clinical trials and clinical diagnostics space. Things done on the clinical development and clinical diagnostics side have to be done in a validated environment. Sophisticated information management systems are needed to do that.”

Paper Can’t Do This

There may be two competing products from large companies, specifically SAS Drug Development and the Oracle Life Sciences Data Hub. Even so, says Malik, things at Waban are going pretty well. “Demand for our products is increasing very rapidly,” he says. “What our company is focusing on is breaking the gap between the submission and electronic data capture (EDC) systems.”

New FDA requirements for submitted data in the electronic common technical document (eCTD) format, not to mention expected requirements to adhere to CDISC standards, are all at the back of customers’ minds, he says. “The data are coming more and more in electronic format and will go to the FDA more and more in electronic format,” Malik notes. “All the processes related to data analysis and reporting that have to handle data are in an electronic format.”

Careful Language

Waban readily concedes a certain amount of industry-wide confusion and sloppiness around the terminology of such words as hub, warehouse and repository. For Malik, a repository is a system to store data in an organized manner. A data mart or warehouse provides the ability to search across multiple data sources for analytical purposes.

“The way we have architected our platform, and the way we approach clinical data warehouses and the processes for clinical data management and clinical trial data analysis is pretty different,” says Malik, whose firm recently helped a customer design a new trial by looking at 20 or 30 old ones.

Product-wise, Waban has several tools. Waban Explorer and Waban CDR are the main warehouse and repository products for the clinical market; Waban SCE is a tool for managing the analysis processes in clinical biostatistics, providing full traceability between reports, programs and data. The Cambridge, Mass. firm also has several other dedicated applications for managing data from pharmacogenomics and laboratory information systems (LIMS).

Looking Across Trials

The nut of the difference between Waban and other firms is that it doesn’t think it’s hopeless to combine genetic, clinical and laboratory data across multiple trials. That’s a novelty: Malik estimates perhaps 5 percent of the industry can look across more than one trial.

As he readily concedes, many past efforts to tie silos of data together have, ahem, not ended well in the pharmaceutical industry. “Technology initiatives that have been taken in the past, most of them have not been very successful,” says Malik. “That is the primary reason companies are hesitant to invest more money.”

Problem Child?

For some Waban projects, he says, warehouses can be set up in as little as 3-6 months or as long as a year or two. It depends on what the customer wants to do, of course.

But paper remains a problem. “This industry is lagging behind,” Malik says. “There is no other industry that is so paper based. We are trying to educate the industry and also trying to insist, by being persistent, that they adopt these newer systems and streamline their processes.”

At The End of The Road

Once the data is linked into the same system, Malik says, it can be analyzed and reported on by any of the standard packages, from S+ to SAS to Spotfire. “We hook up to multiple analysis tools, not just SAS. We are agnostic about the type of analysis tools you use. We don’t restrict our customers to using any reporting or editing program. Our strength is to organize the data, and be able to pipe to the analytics of choice or visualization of choice. People have their own preferences and choices.”

But it’s important to not just stop there, Malik says. The output from the analytical pipeline needs to be managed at the enterprise level to capture the pathway and steps that went into a particular insight. Says Malik: “All that is vital information for anyone to be able to recreate that analysis. We have the capability of tracing the connection between a listing to how it was done. If FDA asks, ‘how was this table created?’ a company has to go through a huge effort to figure that out. We have the ability to do that instantaneously.”

When Others Sift Your Data

This pharmaceutical industry is limping into a new and somewhat stomach-roiling era in which external experts (say at the Cleveland Clinic) are going to exhaustively analyze a company’s once-internal, once proprietary clinical data. Google “Avandia” and “Nissen” if you’re not sure what we’re alluding to.

The bottom line is simple. Every company managing clinical data must have the ability to respond in 24 hours to a third-party analysis of its own data. We’re talking about raising the level of your game, folks. At some companies, to be honest, it will never happen. (The politics and IT issues will be too fractious, the existing systems too brittle and lacking in functionality.) But forward-thinking companies will turn to Waban (or SAS, Oracle and others) to dive in and prepare for a future that is already here.