Info & Opinion
July 21, 2019
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
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Given the highly cautious, risk-averse nature of the people purchasing clinical trial services, one might expect a rough launch for a new imaging core lab in San Antonio, Texas. Intrinsic Imaging was formed at the end of June of this year. Some of its competitors are big, long established and members of the S&P 500.
Then again, maybe Intrinsic's ride will not be so bumpy. It is affiliated with the South Texas Radiology Group (STRG). Intrinsic and STRG share access to the same group of more than 60 radiologists. At any given time, working in such capacities as principal investigator, protocol reviewer, or imaging consultants, STRG doctors are typically working on 100 clinical trials. They are not new to industry-sponsored research.
Nor are they small. The STRG corporate family comprises several organizations, Intrinsic being one. Taken together, the corporate umbrella is one of the top 20 radiology practices in the U.S., with 23 imaging centers and 572 supporting employees. The group handles 2,000 inpatient and 2,000 outpatient exams per day, for a total of at least 1 million exams per year in 12 Texas hospitals.
Intrinsic has recruited a strategist with 25 years in the contract research organization (CRO) industry, some of them at Parexel, a CRO with an imaging core lab of its own. Todd Joron was involved in Parexel's technology division and is now serving as Intrinsic's president and chief operating officer. He didn't jump directly from one firm to the other, but had a year off between posts.
Joron says that it's interesting to contemplate whether each established imaging core lab would choose its current technology all over again. Some might, he allows. Others might not.
Joron doesn't present himself as an all-knowing wizard of technology. But he does say that his counterparts at other central imaging labs may experience an occasional twinge of regret. "I've made wrong decisions in my past," Joron says. "I've learned from that." The life spans of big software systems used by industry may be 10 or 15 years, he says, allowing everyone plenty of time to ponder their choices.
During the past few months, Intrinsic's core lab competitors have been debating the relative importance of therapeutic area expertise, imaging-specific IT and project management acumen. Earlier ClinPage articles can be found here (on Parexel's imaging group), here (on BioClinica) and here (on Merge). Joron says that it's not necessary to choose between any of those elements. "You can have it all," he says. "You can have those three things optimized all at the same time."
Joron is respectful of his more established rivals in the $500 million imaging core lab niche. But he believes that sponsors are not so enamored with existing providers. "Have pharma changed the mix of their imaging providers over the past 5 years? Yes," Joron says, adding that some firms are seeing fluctuations in the amount of work they receive. "There is room," he says. Business is good, and his technology is not an incidental element in why companies are choosing Intrinsic.
"Scalability is critical," he says. Intrinsic considered buying technology, building a system and other options. In the end, the firm decided to rely on another clinical trial and health care informatics firm, Merge, for its imaging management platform.
In a sense, Intrinsic is looking at technology in the same manner as sponsors—as something that may be intelligently outsourced. Says Joron: "We think there is greater power and leverage by partnering with a company such as Merge that is operating and providing software under our guidance."
Merge's system, as it happens, was recently given a rave review by the people at Frost & Sullivan, the IT research firm. Frost declared Merge's system to be a quantum leap above the state of the art in the field, but it is impossible to tell from the press release how thoroughly the research firm assessed Merge and its competitors.
Joron allows that the decision to rely on Merge may be puzzling to some in the industry. But he points out that it's now commonplace to turn to specialized firms for laboratory information systems and transferring digital images for clinical trials. "The not-invented-here syndrome needs to go away," he says. "What is the smartest thing to do to provide the best service to clients? That's what we're trying to do."
The key question, for Joron, is not simply whether imaging core lab competitors will be able to handle complex trials, but whether they will be able to do so at an attractive cost. His clients are sophisticated. They expect some savings to flow back to them. Intrinsic's technology-driven margins are wide enough to permit that. Whether the system is in India, Russia or New Jersey, a lower-cost operating environment is driving sponsors of trials to demand ever-smaller bills from ever-leaner suppliers.
Intrinsic is sufficiently excited about combining Merge's system and its own operational skills that it is staking out levels of performance that other imaging core labs are silent about. Specifically, Intrinsic is publicly stating its operational goals in the standardized format proposed by the Metrics Champion Consortium (MCC).
The core lab industry's ability to deliver on 19 imaging-related MCC metrics and two candidate metrics is not a matter of public record. Most MCC data are private, available only to member organizations. In imaging, some of the MCC targets have been established in a survey of companies familiar with the terrain.
As a general matter, the MCC effort is intended to facilitate consistent definitions of common trial activities, and enable valid comparisons between CROs and vendors working on projects. The unpublished nature of MCC benchmarks will allow high-performance clinical organizations to shout good results to the marketplace, and let lagging organizations remain anonymous. An earlier ClinPage article on the MCC can be found here.
With Intrinsic's permission, we've replicated a chart from the company website to illustrate its intriguing juxtaposition of the MCC standards and its own aspirational numbers. The Intrinsic goal is to shave days or weeks off the MCC targets. There is a second chart on the Intrinsic website that details how the firm intends to surpass all 19 of the MCC metrics in imaging.
In some cases, the targeted time-savings of Intrinsic vs. MCC guidelines are in the 70-90 percent range. "They are dramatically different from what the MCC says," Joron notes. "We're publishing what we already know we can achieve." Even if the company's actual performance varies from its projected results, he says, it will still be a significant gap. As the company completes trials, Joron promises, it will publish statistics about its actual performance.
The Intrinsic targets are not rhetorical flourishes. Joron notes that, as appropriate, the metrics are written into service level agreements (SLA) with clients. The numbers become hard contractual elements. "We didn't take them lightly," Joron says, given that his company can be financially penalized if the metrics are not achieved.
Are the MCC imaging metrics so low that they are meaningless? Joron doesn't think so. "I think MCC is serving its purpose of finding its way to finding what a real baseline is for the industry." And of course, as ClinPage's previous coverage has noted, the MCC numbers don't have to be etched into stone tablets. As the industry improves, the numerical bar can be raised.d9A2t49mkex
Joron has been around the industry long enough to have seen other up and downturns in its fortunes. He thinks that well-run contract research organizations will always prosper. Says Joron: "Even when there is a contraction in the pharmaceutical market and a corresponding slowdown in the CRO market, it always recovers. Imaging CROs are a great place to be."