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By Mark D. Uehling

Special Issue 
· When Behold: Bio-IT Innovators
· When Only Brute Force Will Do
· Breaking Down Silos and Busting Bottlenecks
· Managing Innovation and Adversity
· Prescription for Success: Mix IT and Science
· The Power of Expression
· Taking Data Storage to Infinity — and Beyond
· Profiting from the Proteome
· Serving the National Health
· Powerhouse CRO (Slowly) Goes Electronic
· Talent Fuels Drug Pipeline in Swiss Time
January 13, 2003 | As Quintiles Transnational Corp. began to design a process for starting clinical trials, the company discovered an embarrassing fact: Using EDC (electronic data capture), the startup process took as long as three months, compared to six to eight weeks for a conventional paper-based ramp-up. Getting going with a vaunted new technology, in other words, was taking considerably longer than with an archaic technology based on dead trees. "Customers were not happy," admits Graham Bunn, vice president of the E-Clinical franchise at Quintiles.

Unhappy customers at Quintiles — the world's largest CRO (contract research organization) — are rare. It kept plugging away at the startup process, redesigning it from scratch. Now starting electronic trials takes no longer than paper ones. "We've got startup down to six weeks," Bunn reports. "We've done it in two and a half weeks."

With 17,000 employees and $1.6 billion in annual revenue, Durham, N.C.-based Quintiles is the most successful CRO. The company has run clinical trials for every big pharma at one time or another. "You have to give them credit for trying to expand the vision of what a CRO is," says Steven Zisson, managing editor of Centerwatch, an online and print resource about clinical trials.

Zisson notes Quintiles' size is both an advantage — it reassures pharmaceutical goliaths that studies will actually be completed — and a source of confusion. After years of acquisitions and biotech deals that share the risks and rewards of drug development, some observers wonder if Quintiles might someday morph into a pharmaceutical company itself.

For now, Quintiles is one of a select number of genuinely global CROs, operating in 40 countries. It has finished 15 electronic clinical trials, with a similar number under way, and thus is hardly ignoring the pharmaceutical industry's glacially paced migration away from paper. But the company is going with the electronic flow in its own deliberate way that reflects a results- oriented philosophy.

A Big Dog 
At any time, Quintiles has hundreds of clinical trials in process at thousands of major academic medical centers and more modest medical clinics around the world. Compared to tiny dot-com clinical trial or EDC startups, the breadth of Quintiles' expertise is commanding. The company designs entire trials, from the case report form to the statistical analysis. The company has specialist expertise for clinical research in a huge range of therapeutic areas. A small clinical trial may have just one patient; the largest ones involve tens of thousands of subjects. Doing both well is difficult.

In the IT world, the company may be best known for an unhappy partnership with WebMD Corp. — a relationship that dissolved with a lawsuit and WebMD paying Quintiles $185 million. But in the CRO industry, having been around since 1982, Quintiles plays a quieter role. In November, for example, Quintiles Chairman and Founder Dennis Gillings was instrumental in establishing the Association of Clinical Research Organizations (ACRO), which arranged one of the first public appearances of incoming FDA Commissioner Mark McClellan. "CROs hold great potential to help this process," McClellan told a Washington audience of CRO executives.

Customer Metrics 
Quintiles uses the Internet to survey the satisfaction of its pharmaceutical customers after each clinical trial is complete.

Impressively, given the company's size, every key metric is up, from those measuring overall customer loyalty to satisfaction with how the trials are conducted. "It's all about repeat business," says Diane Clark, Quintiles' vice president of IT for the clinical development services division. "If that metric continues to rise, that means you're going in the right direction."

When it comes to IT, Clark does not subscribe to wishful dreams of greater productivity in the future. "Where we are maturing as an organization," she says, "is being able to evaluate the placement of technology — the proper technology — for a given clinical trial. Sometimes paper is the answer."

'No Silver Bullet' 
It's not that Quintiles is anti-EDC. It's that pleasing customers comes first — not heeding a vague yearning to adopt the latest, greatest technology for its own sake. Drug companies, after all, outsource their clinical trials to CROs because they want their data collected as quickly, cheaply, and reliably as possible.

Building a plan: Customers come first at Quintiles, and survey results attest to high satisfaction. "It's all about repeat business," says Diane Clark, vice president of IT for the clinical development services division.

To meet customers' expectations, Clark notes, Quintiles has a five-year strategic plan, matching people, technology, and business processes, which is uncommon in the CRO industry. "Big pharmas put together strategic plans," she says. "But CROs tend not to do that. That is an important difference for Quintiles. We are light years further along than other CROs in setting a direction and building a plan to get ourselves there."

As Bunn puts it, understanding how technology does or doesn't facilitate the clinical trials process is key. "There is no silver bullet," he says. "It's really about sitting down with customers and working with them as one so that we all understand them as a key stakeholder in our process."

Part of Quintiles' approach has been born of practicality. "Our customers want solutions that work," Bunn says. "We don't want revolutionary. It's an e-volutionary approach, using the tools, modifying the process. I refer to the other vision as a Big Bang approach, which in our highly regulated world is not one that really works, because you throw out everything that you've learned, everything you know."

Indeed, as Centerwatch's Zisson points out, a comprehensive EDC strategy could imperil an important revenue stream for Quintiles and other CROs. They earn their fees by dispatching study monitors around the nation and the world to oversee the nitty-gritty details and overall progress of clinical trials. If such matters could be monitored electronically, there could be a diminished need to send out a human being. "When EDC and e-clinical trials solutions prevail over paper, CROs' core cash cow — monitoring — will be greatly reduced," Zisson says. He predicts that the role of the study monitor will change, possibly shifting into a more IT-intensive job.

So if Quintiles is not embracing EDC as it is conventionally understood, what is the company developing? "eDC+," as Quintiles calls it, is a reconsideration of EDC from the viewpoint of the stakeholders — the people who actually gather or analyze the clinical data. "When we truly get to what we think of as e-clinical," Clark says, "it's not just around the collection of the clinical trial information. There is a vast amount of process and work that happens around that clinical trial process that we want to also make 'e.'"

Old Tools, New Methods 
So for each major type of participant in the clinical trial process, Quintiles says it has tried to figure out how to make the digital collection and processing of information truly faster than with paper. Clark says the emphasis is on the human and process questions: "Eighty percent of the effort is around process and people; 20 percent is around technology."

For Quintiles, traditional EDC is a camel — an ungainly slapping of a few digital tools on top of a paper process. Its eDC+, on the other hand, is a redesigned, streamlined, tried process that eliminates repetitive tasks and allows trial managers to be proactive. Says Bunn: "We see cleaner data, quicker. For a project manager who's making decisions about the conduct of a clinical trial, they can actually make decisions that are informed, because the information is up to date."

Its vision of eDC+, Bunn and Clark say, will use externally developed, commercial EDC tools. But Quintiles will customize those applications, tweaking them to provide reports that automatically identify trouble spots anywhere in the world. Perhaps one clinic is missing a study monitor, or another is generating more than the usual number of queries about the incoming data. The key is to provide real-time information for decisions.

The applications that provide those reports, Bunn predicts, will become a powerful tool for those who run clinical trials. "That really changes the way you approach the trials," Bunn says. "The first application you go to in the morning is your EDC application, not your e-mail."* 


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