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Partnering with Pharma: A New CRO Approach

eClinical 2011: Remedies for the Clinical Trials Machine
The CRO Mike Wilkinson (PPD)

February 1, 2011 | Mike Wilkinson, CIO and executive vice president at PPD, has a message for pharma: “We’re in this together as partners; we’re not a vendor anymore. I think we need to move away from that kind of transactional approach where all they’re looking for is to have a vendor and buy a service. That’s not going to work in this environment.”

PPD is a 25-year-old global contract research organization with offices in 42 countries. Earlier this year they were named the top CRO at the 2010 Site Solutions Summit Eagle Awards. As CIO, Wilkinson’s top priority is to provide PPD’s customers—sponsors, investigative sites, and the internal teams that deliver clinical trials—with agile technology that enables effective and efficient employees, gives sponsors more integrated and trusted data, and creates a superior research experience for investigative sites.

Wilkinson is a former Navy SEAL whose background includes project management and optimization; it shows. His duties as CIO encompass not only technology, but process improvement, global training and business analytics.

“I’m a real firm believer that if you’re just going to throw technology at it, all you’re going to do is increase the error rate faster and… add more wasted time,” he says. “What you need to do is optimize the process first, build the technology around that, train the people, measure it, and do it again.”

Wilkinson says he’s seeing changes in the way that pharma works with CROs, and many of those changes have to do with the role of clinical technologies and implementing what he calls a holistic approach. “In the past when CROs talked about full service, they talked about clinical data, pharmacovigilance, biostats, those sorts of things… In a lot of proposals we’ve put together for sponsors in just the last six months, you’re seeing technology included in that. What they want to know is, ‘It’s all well and good to take over our clinical ops pieces, but how are you going to provide the technology and how are you going to integrate the technology with our current technology that allows us better data access and transparency?’”

For some customers, that means retiring their clinical trial management system and the associated costs, and letting PPD warehouse that data. For others it means building interfaces between the customer’s systems and PPD’s. “My job is to figure out what kind of technologies I can provide that will help [customers] do their business better,” Wilkinson says. “It doesn’t really matter which system is collecting the data, but that the data can be integrated and used by the business. That’s what’s critical.”

The economic climate is forcing closer customer relationships already, especially with pharma sponsors. “There’s no doubt about it, [pharma companies] are expecting more for less; they are more demanding; they are being better stewards of their finances than they have in the past; they are smarter, much more intelligent customers than they’ve been in the past about what technology can and cannot provide.”

Yet Wilkinson believes there’s room for even closer ties and stresses building real partnerships with customers. “The pressures that are being placed on pharma right now are the pressures that we are feeling as well. Not only because pharma is passing them on to us, but because we are in this difficult financial environment as well,” he says.

“As a partnership, we both have to put all of our cards on the table, together, and we have to decide if we want to lower costs together and if we want to build efficiency and improve performance. What we have to do is get rid of the parochialisms, get rid of the idea that we both have to have something in order to check the other—so we both have to have a CTMS system, we both have to have an EDC system. I think we have to get to the point where…we allow each company to focus on their core competency.”

PPD is taking the same approach to its own vendor partnerships. In July, PPD and Microsoft announced an agreement to jointly implement a technology solution to improve efficiency in managing FDA’s Risk Evaluation and Mitigation Strategy (REMS) programs based on Microsoft Amalga Unified Intelligence System. In October, they announced a strategic alliance to deliver clinical and medical imaging services with Virtual-Scopics. These partnerships “increase our bandwidth for providing solutions to our customers both in terms of capacity and capability,” Wilkinson says.

“It’s a business on both sides,” Wilkinson says. “We both have to succeed. If either one of us don’t succeed, neither one of us will.”

This article also appeared in the January-February 2011 issue of Bio-IT World Magazine. Subscriptions are free for qualifying individuals. Apply today.
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