Info & Opinion
June 26, 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
We asked Quintiles to tell us about one of the most improved sites or site networks in its five-year-old partner sites program. The contract research organization (CRO) introduced us to Piedmont Medical Research, a group of 11 sites in North Carolina, South Carolina and Tennessee.
The network is based in Winston-Salem, N.C. It's comprised of nine sites opened by Piedmont and two purchased in 2005. In the early years of decade, it was doing about 350 studies at any one time, but not actively working to land specific ones.
“We just took whatever studies came, and were always busy with many studies and clients and didn't pro-actively seek out additional therapeutic areas,” remembers Amanda Wright, now Piedmont's director of business development.
Nor was Piedmont trying to look at its own performance, or collecting any well-defined internal metrics, or challenging itself to be better. It just did its studies and kept on keepin' on.
Then Quintiles called. As part of an investigator site relationship management program called Access to Patients, the CRO had just started its partner sites initiative, and had been keeping metrics on various large sites in an effort to hand pick a few for strategic relationships. Piedmont, right in Quintiles' North Carolina back yard, had some nice numbers. “Piedmont bubbled to the top of the sites Quintiles was looking at,” says Tommy Littlejohn, president and medical director of Piedmont.
Piedmont and Quintiles started talking. When Piedmont saw how much more work it could get from Quintiles and other CROs and sponsors by being a bit more proactive, it decided to launch into high gear.
The company then restructured, recalls Wright. Instead of many people wearing many hats, employees were organized into departments like finance, operations and IT. Wright, who had been with Piedmont for eight years, became the nucleus of a business development department.
On the heels or those changes, Piedmont decided to focus on collecting specific operational metrics and then organizing “quarterly priorities” around them. Wright explains, “We looked at our contract finalization and first-patient, first-visit numbers—which is not something we had ever looked at very closely at all. Then we started trying to get both down to 10 days. We did that in other areas, too, like regulatory.”
Then Piedmont just kept going, trying to get ever faster at study start up. “After about nine months, looking at first-patient, first-visit quarterly, we then tried to get it down to five. That worked. Now it's at four.”
And what happened when the sites couldn't reach their goals? “We'd look at: why can't it be done?” says Wright. “Are there missing documents? Was the P.I. not available for a few days? We started to assess: when were the times that goals couldn't be met? And then we looked closely at whether that was something we contributed to."
When the sites had been at fault for a goal being missed, often the problem was personnel, says Littlejohn. Piedmont started closely monitoring coordinators and other staff to see if they were as committed to the “quarterly priorities” as management was. “If people weren't meeting their goals, they weren't here anymore,” says Littlejohn, who declined to say just how many employees were let go.
Setting and aggressively trying to reach rigorous goals worked like a charm. Things began to speed up at Piedmont as the site network became a tighter ship. And the site's relationship with Quintiles bore fruit. Now about 10 percent of Piedmont's business comes from Quintiles. In 2007, seven of their trials were courtesy of Quintiles; currently, 41 are. Formerly working in 12 therapeutic areas for Quintiles, Piedmont now works in 18 different therapeutic areas for the CRO.
Once a month, the Quintiles Access-to-Patients manager assigned to Piedmont checks in to discuss recent metrics and anything else that needs to be talked out about current or upcoming studies. Sometimes the two talk more frequently than that. (Here's a story we previously wrote on Quintiles' efforts to forge tight bonds with select sites.)
The rest of Piedmont's clients are mostly big pharma. The site network also has strategic relationships in place with other CROs, which Littlejohn says he really appreciates.
“It's been satisfying because the relationships are just better,” he says. “If we get off track with a study for some reason, due to the closer contact, we deal with it much more quickly now. We're delivering a better product.”
One of the big upsides of close relationships with CROs and sponsors has been the opening of the portfolio, when the client comes to the site to discuss all the upcoming studies it would like the site to work on a few months to a year out. These are a sharp contrast to the more transactional, last-minute meetings the site was used to, says Wright.
“If we can prepare for what's to come in six months or a year, we can do much better internal planning,” she says. “For instance, do we need to add additional investigators? Is, say, a dermatology study coming? If so, we can get out and train investigators well in advance.”
A similar situation spurred Piedmont to add investigators in the area of pediatrics. “A year ago, we were a company that could probably only accommodate pediatric trials at three sites,” says Littlejohn. But after Quintiles and some of the site network's other clients opened up their portfolios and showed that there were more pediatric trials coming down the pike, Piedmont beefed up. Fast.
“We now have six sites that can do pediatric trials; we better positioned ourselves, and it was all driven by having insight early on about what was coming up,” Littlejohn says. “Time is of the essence on these matters—it takes time to forge relationships with new investigators.”
Piedmont has 145 employees across its 11 sites as well as 145 investigators. It has conducted 5,500 studies. Wright says the network considers itself multi-specialty. It doesn't tend to do oncology trials.
Piedmont has been using proprietary software called StudyTrack, but it's no longer doing the trick, says Wright. “We designed it as a single-site application long ago and have forced it to integrate.” Early next year, the network plans to roll out more modern, more integrated software called InSite.
What's next for the large, mostly home-grown network? Is it done closely scrutinizing all its operations? Likely not, says Littlejohn. “I feel confident that we still may be missing something,” he says. “Maybe there's something we need to look at differently. Next, we plan to look at everything we've already been looking at, but with more awareness about safety concerns. How can we improve randomization? Documentation? We want to get better and better at quality and safety.”
—by Suz Redfearn