Service:
Trial Rescue & Restructuring
Client:
Well-Funded Startup
Duration:
15 months
CONFIDENTIALITY NOTE:
This case study represents a composite of multiple client engagements in remote patient monitoring. Specific details including exact device type, indication, company information, and metrics have been modified to protect client confidentiality and comply with NDAs. The methodologies, challenges, and outcomes described are accurate representations of our work.
Their Clinical Trial Was Off the Rails
The founder had strong credentials—PhD from a top-tier university, nearly a decade at a major tech company in healthcare. She'd built a remote monitoring algorithm that could detect physiological changes and alert clinicians before symptoms became critical.
She'd raised significant funding to bring it to market.
But 14 months into her first clinical trial, nothing was going according to plan.
Where things stood:
Enrollment: Below 50% of target
Budget: Over original plan by 20%+
Timeline: CRO was projecting "at least 18 more months"
Sites: Multiple sites enrolled, but most weren't recruiting patients
The warning signs: Every month, the CRO would send another invoice with line items for "scope changes" and "protocol amendments." When the founder pushed for explanations, she'd get vague answers about how "clinical trials are inherently unpredictable."
Her board was losing patience. At the last meeting, they'd put two options on the table: shut down the trial and pivot to a different approach, or keep funding it and hope things improved.
She didn't like either option. That's when she reached out.
Week 1-2: Emergency Diagnostic
I started with what I always do when a trial is struggling: a complete audit.
I reviewed every document—protocol, informed consent forms, site agreements, the CRO contract. I pulled enrollment data for every site, every week since the trial started. And I did something the founder hadn't thought to do: I called the site PIs directly, without the CRO on the line.
What I found:
The protocol was a mess. It had been written by the CRO's team without enough input from people who understood patient recruitment in this therapeutic area. The inclusion criteria were too narrow (excluding a significant portion of potentially eligible patients), and the visit schedule required patients to come in multiple times over several months. Most patients weren't willing to commit to that.
Of the enrolled sites, most had enrolled very few patients over more than a year. They were still getting paid monthly fees, but they weren't performing. A small number of sites were carrying the entire trial.
The CRO had no incentive to fix any of this—they were billing monthly per site, so more sites and more time meant more revenue for them.
By the end of week 2, I had a presentation ready for the founder and her board.
The assessment: "This trial is salvageable, but we need to act fast. Here's what needs to happen: amend the protocol, cut the underperforming sites, bring in better sites, and restructure the CRO contract. If we move now, you can complete this trial in 8-10 months."
They voted to move forward.
Month 1-2: Restructuring
Protocol Amendment
We rewrote the key sections of the protocol to make enrollment realistic:
Simplified inclusion criteria (opened up the patient pool significantly)
Reduced required visits
Streamlined the primary endpoint
I worked with a regulatory consultant to prepare the amendment package, and we submitted it to FDA. About six weeks later, we had written feedback: approved with no substantive changes required.
Site Strategy
We cut the non-performing sites immediately. The CRO pushed back hard on this (it meant less revenue for them), but the data was clear—these sites weren't contributing.
I reached out to clinical sites I'd worked with on previous trials in this therapeutic area. We brought on sites with high patient volume and experience with similar device studies.
CRO Contract Renegotiation
This part took several weeks and wasn't pretty. The founder brought in her lawyer, and I helped her build the case: the CRO had missed contractual performance milestones, and the client had grounds to terminate.
We didn't terminate—but we renegotiated. New terms included reduced monthly fees (fewer sites meant less scope) and performance-based milestone payments. If enrollment targets weren't hit, the CRO didn't get paid.
They weren't happy about it, but they signed.
Month 3-10: Execution and Oversight
My role for the rest of the trial was straightforward: make sure everyone stayed on track.
Weekly check-ins: Every Monday, I'd review enrollment numbers with the founder and the CRO project manager. If a site went two weeks without enrolling a patient, we'd dig into why and figure out how to fix it.
Site performance: We implemented quarterly performance incentives for top-enrolling sites. It cost extra but created healthy competition among the sites. Enrollment rates improved noticeably.
Materials and processes: The CRO's patient recruitment materials were too clinical and intimidating. We rewrote them in plain language. The founder's team actually did most of this work; they knew how to make things user-friendly.
The trajectory:
Early months (restructuring period): Enrollment was slow while new sites ramped up
Mid-trial: Enrollment accelerated significantly
Final months: Strong, consistent enrollment across sites
By Month 10 after I started, all patients were enrolled and the trial was complete.
From Crisis to Clearance
Timeline comparison:
When I started:
Enrollment significantly behind target
CRO projecting 18-24 more months to completion
Projected FDA clearance: 30+ months from start
What actually happened:
Trial completed: 10 months after I started
510(k) submitted: Shortly after trial completion
FDA clearance: Several months after submission
Time saved: 8-14 months compared to original trajectory
Cost impact:
I can't give exact dollar figures (NDA), but here's the general picture:
Original path would have meant 18+ more months of CRO costs and operational burn. Even at their relatively lean burn rate, that's substantial additional spend.
Actual cost to complete the trial after intervention was significantly lower than projected.
My engagement added to their costs, but they came out well ahead overall.
Business outcomes:
The founder raised her next funding round two months after FDA clearance. The lead investor? The same one who'd wanted to shut down the trial months earlier.
They launched to their first customers within months of clearance and hired a full-time Head of Clinical Operations (I helped with the search and onboarding).
Last I heard, they're growing rapidly and the product is performing well in the market.
WHAT MADE THE DIFFERENCE
Pattern recognition
I'd seen failing trials like this before—multiple times. I knew what to look for in the first week, and I knew what solutions actually work vs. what sounds good in theory.
Speed of diagnosis
The faster you identify what's broken, the less money you waste. Two weeks to audit and present a fix plan isn't magic—it's just experience and focus.
Willingness to make hard calls
Most advisors won't tell you to fire your CRO mid-trial or cut half your sites. It feels too risky. But sometimes keeping dead weight is riskier than cutting it.
The founder's courage
None of this would have worked if the founder hadn't been willing to make tough decisions fast. She made the hard calls. She stood up to the CRO. She put in the work to fix what was broken. I advised—she executed.
Lessons Learned
1. MOST FAILING TRIALS HAVE FIXABLE PROBLEMS :The protocol was salvageable. The sites could be swapped. The timeline could be recovered. But only if you act fast—waiting another 3-6 months would have made it unfixable.
2. CRO'S DON'T SELF-CORRECT: If your CRO is underperforming at Month 6, they won't magically improve at Month 12. You need outside oversight or you'll keep bleeding money.
3. FOUNDERS NEED PATTERN RECOGNITION : First-time founders don't know what "normal" delay looks like vs. "your trial is broken" delay. Experience matters.
Name Withheld (NDA)
CEO, Digital Health Startup *Client confidentiality maintained
