Info & Opinion
April 25, 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
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
M. Denis Connaghan is the new CEO at etrials. He’s been on the job a bit more than a month, since mid-November, and had just returned from meetings with clients on the west coast when we rang him up for a chat.
“I didn’t hear, ‘we need another product from you. We need another technology from you,’” Instead, Connaghan reports, the message was more service-oriented. “‘We need you guys to be better at what you do.’ That’s going to be the focus. Where our focus is going to be initially is in perfecting what we do.”
We asked Connaghan about how customers weigh service and technology. “Service is key in this business,” Connaghan said. “What I heard from our customers was they do like our technology and do like our product. Where we could improve would be service. We have to be sure we’re delivering the service they expect and need.”
The company is unusual in that it links several key technologies in a unified manner—electronic data capture, clinical trial management, patient diaries, randomization.
That approach is not the prevailing one in the industry. Most companies prefer to have several important stashes of clinical data, and to pay people to triangulate between them to figure out which stash has the most current information on a particular topic. Or sponsors and contract research organizations pay, again and again, to knit the same technologies from different companies together. Because large pharmaceutical companies have the funds, IT knowledge and inclination to take on that integration of technologies, smaller companies follow suit.
And while all that is popular, it does not necessarily make sense. If the pharmaceutical industry purchased books the way it collects clinical trial data, it would go to one company to get a list of titles of books, another to search for books on the list, a third to actually buy books from, a fourth to ship the books, and a fifth company to track which books had been purchased. Clinical technology companies like etrials, DataTrak and even Oracle are seeing themselves more as research-oriented versions of Amazon.com, with one-stop shopping. But they are not the fastest-growing names in the field.
The degree to which the industry warms to a more integrated, connected vision for clinical tools, and starts to rethink trial-by-trial knitting projects, is a crucial dynamic affecting the future of etrials. Says Connaghan: “There is a little more increase in the EDC/IVR combination. The combination of the technologies is something that we are trying to leverage, and it’s getting acceptance in some of the new deals.”
The company’s marketing pitch is being tweaked slightly to reflect the “adaptive” study, in both a biostatistical sense and in a general way. “To be effective with an adaptive trial, you must use technology. We need to be in a position to be nimble and responsive enough for our customers in their use of adaptive trials,” he adds.
But some of the need for technology and flexibility is being driven by the darker investment climate, in which some biotechs are charging ahead, and others are worried about burning cash. Says Connaghan: “Priorities are being changed, whether in the big pharmaceutical company or a biotech that is venture capital-funded.”
We asked Connaghan about how much the incoming Obama administration will change the drug industry and health care. He recalls a similarly ambitious health care agenda during the Clinton era—and how quickly it bogged down in an acrimony-oriented Washington. “I think we’ll see changes,” says Connaghan. “I don’t think we’ll necessarily see the radical changes that were talked about in the campaign. This is a tough business to change.”
That conservatism extends to the industry’s use of technology, he notes. “There was still what I would call limited adoption of technology,” he says of the drug industry, still heavily dependent on paper. “Technology is the only way they are going to be able to respond with speed to market and quality of product that is being imposed on them. There is still what I would call limited adoption of technology,” Connaghan says.
After our conversation, etrials announced another reorganization. “We’re moving aggressively to deliver the most possible value to our customers and seize the new opportunities we see ahead for drug and medical device development,” Connaghan said in the press release. “The eclinical market is continuing to grow and evolve at a rapid pace, and we’re reshaping etrials to be a leader in this transformation, just as we did successfully three years ago. Our strategy capitalizes on big emerging trends and leverages our core strengths in data capture, end-to-end trial visibility and tightly managed control mechanisms.” The company said Chuck Piccirillo, Stuart Thiede and Michael Harte will be leaving the firm.