We've always thought of clinical data managers as members of what amounted to a quasi-religious order, like the Franciscans. Data managers serve as scientific priests, guiding wayward medical information back into the light, anointing and condemning clinical computer systems as appropriate.

Then we got on the phone with Nagaraja Srivatsan, VP of the life science practice at Cognizant. It turns out that data management is a business.

And while rivals are hardly absent from the high end of life sciences consulting, some of Cognizant's competitors are less visible of late. IBM insiders say the firm is soon to move jobs offshore and fire another 2,000 employees in the U.S. Accenture was tightly involved in fixing the clinical systems and processes at Wyeth; the companies vowed to radically alter clinical development timelines and paradigms. But it's not clear if Accenture's approach survived Pfizer acquiring Wyeth. So outsiders may never be able to quantify whether the Accenture-Wyeth partnership produced real results relevant to other companies in the industry—or whether the arrangement was just fodder for feverishly hopeful presentations and self-promotional thinking by proponents.

Clinical Army

Cognizant, meanwhile, is adopting a more understated, sober approach. It's taking on massive, sophisticated process change assignments that use employees with significant amounts of postgraduate education and on-the-job training inside pharma. One megaproject, which Cognizant declined to discuss, is a multiyear engagement with AstraZeneca.

Srivatsan has been at the firm for 8 years. He has an impressive number of people working for him: 7,500, or roughly ten percent of all Cognizant staffers. Not long ago, Cognizant brought on 450 workers just for a single client. By head count, the life sciences operation could be considered one of the top ten contract research organizations (CROs) in the world, although of course other CROs might not necessarily embrace Cognizant as a peer.

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Nagaraja Srivatsan of Cognizant

Srivatsan notes that while some big CROs have traditionally been skeptical about functional service providers (firms that do one thing well) they're now coming around to that view. And his firm, he says, is accepting more and more types of work traditionally done by CROs. "The CROs are becoming more like us. We're becoming more like CROs," Srivatsan says.

Budget Heat

He is quick to add that if clients want a standard outsourcing arrangement in which cost reduction is the main goal, the company can certainly oblige. But Cognizant is more focused on a more elusive goal. "We try to enable the business transformation," Srivatsan says. "Cognizant has a truly unique value proposition. A sponsor can give us a protocol and we can do everything to get you a submissions document." Specifically, he says, the company can help with coding, with statistical review, with regulatory affairs.

Pharmacovigilance is a relatively new area for the firm. Cognizant can help with call centers and case processing. Says Srivatsan: "We are sitting down and helping our customers handle FDA queries." With the mundane high-pressure reporting of spontaneous adverse events and serious adverse events taken off their shoulders, Srivatsan says, internal drug safety staff in the sponsor company can function as strategic thinkers again.

And transformation? Srivatsan is not tossing around the term casually. Cognizant believes that data integrated from multiple systems will become increasingly important, and that big efficiencies and change will be driven by data integration.

"That synergy and interaction between process integration and IT and infrastructure will give many clinical organizations quite a bit of transformation," he says. "There is no power in data. There is power in integrated data." The advent of electronic health records (EHRs) integrated into clinical trial systems, he predicts, will slowly make the monitoring profession less dependent on traveling to investigative sites.

Beyond India

To that end, the company is building several advanced repositories of clinical data to connect the heavily fortified information silos the industry has carefully erected over the years. The firm is doing both customized projects, and using clinical repositories sold by SAS and Oracle.

One key to helping with clinical projects, and one similarity to traditional CROs is that Cognizant is using nurses, physicians and other dedicated trial-savvy people in places like Hungary and China, Argentina and the Philippines. "We are no longer an IT firm," Srivatsan says. "We are not a one-trick pony."

In a brutal economy, Srivatsan reports, deals are starting to flow in big pharma. "We are not seeing a slowdown," he says.

But the pressure for cost-containment is intense. "Gone are the heydays," Srivatsan laments. "American pharma is under severe cost pressure. They are looking at every cost center." After seemingly endless numbers of reorganizations and mergers, life science companies are harshly reassessing their research costs, and bowing to investors and financial analysts worried about massive clinical development budgets that rarely produce new products.

Transform & Perform

All of which presents a paradox. A radically different way of working is necessary. But how to pay for it and support large, complex trials? Says Srivatsan: "We give you a self-funding model. We will give you savings, but plow back that savings into the transformational infrastructure you need. Transform while you perform."

Srivatsan gives a hypothetical example. Suppose your budget for data management is $1 million. Suppose he can handle the data management in ongoing projects for $650,000. Rather than just hand the company's accountants back $350,000 in savings, Cognizant's proposition is to spend $200,000 on a system or informational dashboard that delivers greater efficiencies in the future.

What sort of efficiencies? Perhaps trials that start after 800 days of planning, not 1,000. Trials that finish faster. In some cases, Srivatsan says, those efficiencies may give sponsors no need to conduct entire trials because the necessary answers will already be in hand. That could save tens of millions of dollars for some sponsors.

Cognizant's approach constitutes a new model for services and technology in clinical trials. It's premature to say if Cognizant, Accenture and smaller rivals can provide significant cost savings or operational advantages to the sponsor community. But the firm's impressive size and growth already have significant competitive ramifications for CROs. Outsourcing firms that have more diminished familiarity with—and appreciation of—technology may need to rethink that strategy.

Editor's note: The first published version of this story mistakenly included a total revenue figure for Cognizant in the life sciences, something the company does not disclose as a matter of company policy.

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