How Keenova Reignited A Stalled Trial

By Dan Schell, Chief Editor, Clinical Leader

As an editor, this is the power of just being at a conference like SCOPE: You have the opportunity, often through random conversations, to come across unexpected stories that would make good articles for your subscriber base. That’s what happened when Carrie Lewis, executive director, clinical program optimization at Keenova (she’s also a member of the Clinical Leader Editorial Board), strolled up to our exhibit booth with her coworker Suzy Montanye, site relationship manager.

The two started talking about a study of theirs that had stalled and the surprisingly simple tactics that brought it back to life. Carrie leaned in and said, “You should interview Suzy and Dana about this. What they’re doing isn’t flashy, but it’s working.”

That comment stuck with me because it echoed a theme Carrie raised when I interviewed her last year for The Case For Research-Naïve PIs: Innovation in clinical research doesn’t always come from new technology; sometimes it comes from rethinking how we engage the people doing the work.

A few weeks later, I spoke with Montanye and Dana Plummer, clinical trial manager at Keenova, about how a difficult-to-enroll Phase 3 orthopedic study regained momentum — not through new platforms or automation, but through relationships, creativity, and a willingness to listen.

When Enrollment Momentum Fades

By the time the team reassessed the study, it had been running for nearly two years. Enrollment had slowed, screening failures were high, and sites were juggling competing priorities. What had started with energy and focus gradually became just another demanding protocol competing for attention.

“We had hit a plateau,” Plummer told me. “Sites were engaged, but enrollment is hard in an indication like this. After a while, it just gets tougher to keep momentum.”

Montanye, who previously had worked for years at a site, agreed, saying that fatigue is inevitable in long-running trials. “After a study’s been running for a while, it’s hard to keep it top of mind,” she said. “Sites have multiple trials and competing demands.”

Rather than escalating reminders and pressure, the team reframed the problem. Instead of asking why sites weren’t enrolling more patients, they asked what sites needed to stay engaged and productive. Sure, I’ve heard other sponsors tout some form of this “site-centricity” strategy, but quickly Montanye and Plummer made me think this was more than just a marketing ploy.

An Unusual Gamble

The turning point came when several high-performing sites credited a smaller recruitment vendor they were using independently. Instead of defaulting to familiar large vendors, Keenova listened and expanded their recruitment partnership to include that vendor. As Montanye said, “That’s a gamble a lot of pharma companies aren’t willing to take.”

The vendor’s approach was intensely personal. They contacted sites directly, trained staff themselves, and even helped resolve IRB approval challenges. It was a no-brainer to see that kind of personalization mattered. “Sites loved having direct contact. It built trust,” Plummer said.

Eventually, referral volume improved, but the deeper impact came from responsiveness and collaboration. Listening to sites didn’t just improve recruitment flow; it reinforced that their voices influenced decisions, which strengthened engagement across the study.

Simple Communication Could Yield The Outcome You Want

Recruitment support alone didn’t solve the engagement problem, though. The team also rethought how they communicated with sites and how sites communicated with each other. Weekly email updates were redesigned to be engaging rather than perfunctory. Motivational quotes, seasonal themes, and even a holiday parody song turned routine updates into messages sites actually wanted to open. The emails also highlighted study coordinators — not just PIs — recognizing the people doing much of the day-to-day work.

Monthly coordinator calls evolved as well. Instead of top-down updates followed by silence, the team invited coordinators and investigators to share what was working at their sites. Hearing peers discuss recruitment strategies, workflow improvements, and operational hurdles created credibility that sponsor instructions alone rarely achieve.

Plummer saw the impact almost immediately. “The week after those calls, engagement increased,” she said. “Sites would reference what others shared and ask how they could implement similar ideas.” The calls became conversations, and the study became a shared effort rather than a sponsor directive.

Relying On A Tech Revolution Is Shortsighted

Montanye’s outreach philosophy reflects her two decades working at clinical trial sites. “Sites hate calls that ask, ‘How many have you screened?’ My question is, ‘What can I do for you?’” Sometimes that meant troubleshooting systems in real time. Other times it meant adjusting communication frequency or simply listening to challenges. That shift in tone — from monitoring performance to offering support — strengthened trust and responsiveness. “No site wakes up in the morning planning to do a terrible job,” Montanye said. “If nothing is happening, there’s a reason. Our job is to understand it.”

One of the most meaningful changes involved site budgets. Recruitment demands and pre-screening requirements had grown beyond what sites planned and increased costs significantly, so Keenova revisited budgets and worked with sites to ensure they were fairly reimbursed for additional effort.

Montanye emphasized that transparency makes adjustments easier. “If sites can show the time and resources required, we can work with that,” she said. For sites accustomed to hearing “you agreed to the budget,” the willingness to revisit terms mid-study reinforced that they were true partners rather than interchangeable vendors.

The study involved roughly 60 sites, a scale that allowed Keenova to maintain direct relationships. Both women believe the approach can scale if organizations invest in dedicated relationship roles and empower teams to respond to site feedback.

And considering, these days, AI and automation dominate most industry conversations, Montanye sees a risk in overlooking the human element. “We’re not ignoring technology, but relationships are what make us successful. When people trust each other, they go the extra mile.”

Plummer concurs and says that she’s watched that dynamic play out in real time. “People are reaching out excited about screenings,” she said. “They feel like true partners.”

Don’t get me wrong — none of the tactics Keenova employed were revolutionary. They involved listening, recognizing contributions, encouraging collaboration, and compensating fairly for real work. Frankly, elements you would think to be table stakes with sponsor-site relations. But that’s not our current reality. So, for Keenova, embracing these simple actions helped revive enrollment and reenergized sites that had begun to disengage.

I love the simplicity of this initiative, especially in an industry where we are constantly chasing the next “digital transformation.” I know it sounds touchy-feely and cliché, but this is a good reminder that clinical trials still run on human relationships. When sites feel respected, heard, and supported, progress follows.