Info & Opinion
December 8, 2016
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
Are there truly singular contract research organizations (CRO)? Or are CROs interchangeable, like airlines? It's not an academic question in an era when drug, biotechnology and device firms are offloading large and sacred clinical programs to outside firms.
The work done by every CRO—science—is driven by government regulations that permit little deviation from international norms. And the frequency with which sponsors hire and fire CROs would suggest that everything can be reduced to the lowest quoted price, or to deals hammered out by two colleagues who trust each other.
But there is an intriguing counter-example in Parexel. The Waltham, Mass. firm has 10,300 employees and $1.3 billion in annual revenue. It has walked a different road in ways that initially made Wall Street nervous. Some of the analyst head-scratching has stopped in the wake of last month's announcement that Pfizer had selected Parexel as one of two preferred providers.
"This new strategic partnership model is part of a comprehensive program to sharpen our research focus at Pfizer, and creates a more flexible cost base through outsourcing of certain research and development services,” said John Hubbard, Pfizer's senior vice president, worldwide development. Is it a coincidence that Icon, the other preferred provider chosen by Pfizer, is also more tech-savvy than peer CROs?
Alone among its rivals, Parexel has spent hundreds of millions of dollars buying or building clinical trial technology. In the late 1990s and early 2000s, electronic clinical data were considered a novelty. Back then, representatives from some CROs stood up at conferences and praised paper forms, making derisive statements about automation and technology.
There were no antiquarian tendencies at Parexel or its IT division, Perceptive Informatics. For one of the architects of that strategy, chief operating officer Mark Goldberg, software has always been something that should be deployed by a clinical services firm.
In one recent project, for which he provided few other details, Goldberg said the company's use of technology enabled one trial to start up 35 percent faster than industry benchmarks. Patient recruitment was 75 percent faster. "We would not have been able to do that had we not made those investments," says Goldberg, a radiologist by training.
In a presentation at the Partnerships conference earlier this year, and in a conversation with ClinPage, Goldberg made it clear that services and technology should be inextricable. Recognizing some of the pain sponsors experience in merging different types of data, the Parexel-Perceptive vision is now moving away from the concept or terminology of "integration."
"We provide a total solution," Goldberg says. He goes on to say that the company is seeing a shift in decisions in the sponsor community as technology becomes an obligatory, familiar element in every trial. "In this context, sponsors become relatively less prescriptive about which tools must be used," he says.
In short, he says, sponsors are starting to consider the entire technology package for a trial or clinical program, not selecting specific solutions as if they were choosing a beloved shirt and tie to be worn repeatedly, every day of the year.
Says Goldberg: "It's important that the technology is thought about from the beginning. We see now many more discussions about how the platforms used by the sponsor and CRO can be brought together." He doesn't feel the CRO industry will be able to avoid using technology: "You have to be proficient with technology going forward. Efficiencies are absolutely being demanded by the client base, and technology is core to being efficient," he says.
A Parexel customer, Merck, spoke at the same Partnerships conference that Goldberg addressed in the spring of 2011. Merck has traditionally been inclined to build big computer systems internally. But it sounds like that is changing, in part thanks to turning over some tasks to Parexel. "We were able to increase cycle time and improve productivity," said Lynne Germscheid, Merck's director of account management, clinical and regulatory systems. "We were able to decrease monitoring and site visits, which was a great reduction in cost."
To be clear, Parexel is still promoting, building and supporting the use of individual systems for individual trials. It would be premature to predict a transition to some glorious world of a single clinical trial database powered by seamlessly interlocking programs that all rely on data from each other. As far as we know, that unified vision has not been realized by any CRO. Smaller firms than Parexel—Almac, Clinipace, Target Health, even DataTrak—also take technology and more unified product suites seriously.
Still, it's clear that a unified database, with a single password at one Internet address, is the general direction that Parexel believes the industry would now like to take. "In a converged environment, we are talking about the creation of platforms," Goldberg says. "What becomes relatively less important is the individual features and functions."
Goldberg sees a link between the firm's technology portfolio and recent client wins. "Any data intensive business should be enabled by technology," he says. "We believe the reason we’re taking market share is in part related to that strategy. It is a strategy that increasingly resonates with our client base."
In the past, he says, the use of a particular brand of clinical data management system might have provoked a vibrant sectarian debate. No more. Says Goldberg: "No one would have this discussion today. It’s irrelevant. As we get over the adoption hump, this becomes a less significant topic."
Parexel offers one of the broadest, deepest suites of programs for clinical trials in the industry, a mix of internally developed systems (such as Impact) and externally acquired ones (from ClinPhone and Datalabs). The company has tools for adjudication, diaries and imaging.
But for Goldberg, the firm has three mission-critical systems that form the foundation: a) electronic data capture (EDC); b) randomization and drug supplies; and c) clinical trial management. "Those three things are really the core," he says. "We’ve believed this for a long time. This wasn’t a popular idea."
Inside the company, it seems, the process of restructuring to a digitally enabled business model was not necessarily fun. "Like any large transformative change, it is difficult, time consuming, expensive and painful," Goldberg says. "But to be competitive for the long term, we needed to do that. The industry was changing so fundamentally that we had to do a transformative change."
Customers and analysts, he says, chided him and other senior executives at Parexel about competing CROs that had abandoned technology as a key strategic issue. His firm did not waver. "We had confidence that the right way to deliver with our customers was with a comprehensive solution that delivers the technology and services," Goldberg says.
That sounds obvious in 2011. But it was prescient. The decision to embrace software is now the starkest line of demarcation in the CRO industry. It is not a settled matter. Some CROs are following Parexel's example and building their own systems. Others are remaining agnostic about technology, and partnering with a few top software houses (Oracle, BioClinica or Medidata) to serve sponsors that no longer want to worry about the details.
At this stage, Goldberg believes, most top CROs are not concerned about simply owning technology. They're focused on speed, ease of use, scalability, economics. "The question is how well can you do it, how efficiently can you do it, how cost effectively, how easy is it for the people who have to work with the system to do the trial? The more complexity you get into, the more benefits you derive from more integrated solutions," Goldberg says.