Every year, across the globe, hundreds of new companies enter clinical development. Venture capitalists, academic scientists, refugees from big pharma—all of them invigorate and enliven industry science.
But awareness of best practices in clinical development isn't always evenly distributed. Certain domains of knowledge (command of a therapeutic area, say) seem to be more comprehensively represented in young companies. That's a concern at Quanticate, a contract research organization (CRO) that specializes in data management and biostatistics.
"A lot of these are virtual companies with venture capital backing," says CEO and chairman David Underwood, who sat down with a reporter at the 2012 Drug Information Association annual meeting in Philadelphia. "They have clinical backgrounds. They don't grasp the importance of the biostatistical design and analysis."
In a startup biopharma environment, every dollar, every euro is precious. It can be tempting to allocate limited resources to areas that seem likely to help the company cross a distant finish line.
Underwood shakes his head ruefully. He's seen companies try to take shortcuts. "We've worked with some virtual companies," he says. "They have come to us for rescue. They have not designed the trial properly or analyzed it properly. They have let good drugs go because they have not done the data part."
Says Underwood: "You want that data to have integrity. Everything should revolve around the data. People cut back on the data part. They think they're doing it because they're saving money. They're not."
Underwood believes the term centralized service provider (CSP) could be helpful to the industry. Why a new term? The proliferation of partnerships and strategic sourcing relationships is having unintended consequences that require a new idea.
Enter the CSP. In Underwood's view, a CSP could describe a trusted, specialized, go-to company where a sponsor designates a particular task or type of work should always be centralized. Unfortunately, he reports, some unknowable but significant fraction of work in the clinical trial space is duplicated. A centralized location would allow one firm to specialize and attain the efficiencies that the drug industry presumably wants.
"We're putting our hand up and saying, hold on, think about your data," says Underwood. "Shouldn't that be a strategic priority? Should you have half of your data there, and half over here?" Some sponsor firms, of course, will be very nervous about being overly reliant on a single supplier that could be buffeted by any number of business developments.
In some cases, Underwood says, mid- and small-sized sponsor firms are looking at the epic CRO-sponsor deals being done by mega-CROs and sponsors. They want a different model. Notes Underwood: "What they're saying is, 'The data doesn't seem to fit in these types of relationships. It's not quite working well for us.' "
Based in the United Kingdom, Quanticate has in the neighborhood of 200 people on its staff. Says Underwood: "We focus on data. We have a high proportion of experienced statisticians. What we're trying to say is, combine the biometric functions into a central provision."
The goal is to simplify those unruly diagrams of which firms do what across all trials. "If we can standardize database design, then we can use the same programs over and over again," says Underwood. "We'll be using the template we set up for you. You'll get a saving. We work across the data across all our functions," whether that is biostatistics, medical writing or data management.
The savings in time and money will be serious, he believes. "If you have all those things under the same roof, in theory you can get to the final point all that much sooner. "
In a few cases, some CROs have historically been a bit touchy on the question of how, whether and when clients can peek at clinical data as it rolls in. Some CROs have addressed this; others have not.
Underwood is trying to take the issue off the table. He's giving customers access to an internet portal. With the right user privileges, a user should be to see any appropriate, available aspect of the project. Underwood understands that some sponsors may want to push a button and export their data to another CRO with a different set of duties. He's OK with that. "We don't want to lock companies in," he says.
Looking ahead, Underwood hints of an R&D initiative within Quanticate that might affect the typical budget of standard clinical trials, especially antiquated processes that are virtually sacred in some quarters of the industry. "We are not going to keep sending thousands of clinical research associates all over the place. We don't have to do that. It's got to change," Underwood says.
Editor's Note: Here's an earlier article on the company.d9A2t49mkex