The Protocol Stress Test counts how many patients actually qualify under your draft protocol, shows what each criterion costs, and names the sites that can reach them. Delivered by our team in days, before the protocol locks and before you commit the runway. Fewer protocol surprises, and a plan your board can check.
A protocol that cannot enroll does not announce itself at the start. It shows up as a slow ramp, then an amendment, then rescue sites at a premium, then a milestone that lands a quarter late. Every one of those costs more than the decision that caused it. The only time it is cheap to get right is before the protocol locks and the first site is chosen.
You are in that window right now if any of these is true:
Same protocol, same runway. The only difference is whether the sites were chosen on a guess or on real, counted patients.
Counted patients → sites that reach them → a ramp that holds → you hit the milestone on plan.
Enrollment gap → protocol amendment → rescue sites → the milestone lands after the money runs out.
Illustrative. In biotech the timeline is the asset. Enrolling on plan is what protects it.
Large pharma has always had this kind of read before committing to a trial. Small biotech usually finds out the hard way. The Protocol Stress Test is that read: protocol feasibility for biotech, delivered by our team in days, not a feasibility cycle.
One fixed fee per protocol, quoted on the call. It covers the re-runs. It is the go or no-go gate before the raise, and it costs a fraction of finding out six months in.
This is the part of the stress test that changes protocols. Each line below is a draft eligibility criterion with what it costs in qualifying patients. Toggle any of them and the counted pool, the reachable sites and the verdict update. The clinical call stays yours; the count is what makes it an informed one.
Open the two low-risk criteria and see what the published program saw: nearly three times the pool, same scientific intent.
A site list your board cannot interrogate is a site list they will not fund. So every rank we hand back carries the same things, in plain language: the counted patients the site can reach, the investigator’s real enrollment record, and why the site made the list or was cut. Pick a site.
Regional Medical Center
Chosen · high qualifying-patient access and a proven enroller
Illustrative example. No real site or investigator data.
Put in your own numbers. The slip is the part nobody budgets for: the months between the enrollment plan and what the sites actually deliver, paid for at your full burn.
Everyone has the patients. The difference is knowing which sites are real and how many patients actually qualify under your protocol, even for rare and hard-to-find populations. Counted, not inferred: the read large pharma has always had, made reachable for teams where every trial counts.
You do not need a feasibility department to get this right. You need a straight answer at three moments, and a team that hands it to you rather than a tool you have to run. Here is what we hand back at each one.
Every eligibility criterion has a price in patients, and a draft protocol can quietly strangle its own enrollment pool. Before it is locked, we show you what each line costs in qualifying patients and where the protocol can safely open up.
A bigger eligible pool only matters if your sites can reach it. We count the qualifying patients at each candidate site and pair them with the investigator's real enrollment record, so the marquee names that would have failed come off the list before you pay to activate them.
The question your board and your investors will ask, and the one a slow ramp answers for you six months late. You walk in with a number for every site and the investigator who will deliver it, and you commit the runway to a plan your board can check.
We are at OCT New England on 27 and 28 October. Book twenty minutes with Dustin Caldwell and see the stress test walked through on a real rare-disease program. Bring your indication; send the draft protocol afterward and get the same read on your own trial in days.
In a recent rare disease program, testing the protocol against real patient records nearly tripled the eligible pool. It then became a ranked list of the sites that could actually reach those patients, before a dollar of startup budget was committed.
What is the Protocol Stress Test?
One read of your draft protocol against the real patient record: how many patients actually qualify as written, what each eligibility criterion costs in patients, and the sites and investigators that can reach them, ranked with the reasoning. It is re-run if you amend, and it becomes the full site workup when the trial advances. It is the go or no-go gate before the raise. What is in it →
Can we see it before we commit?
Yes. Book a twenty-minute preview and we walk you through the stress test on a real rare-disease program, the one in our published case study, so you see exactly what comes back. A count on your own protocol follows once we are engaged. Book the preview →
What does it cost?
One fixed fee per protocol, quoted on the call. It covers the re-runs if you amend, and it costs a fraction of what a slow ramp costs six months in.
How does an engagement start?
With a twenty-minute preview on a real program. Then you send the draft protocol, and our team comes back with the stress test in days: the qualifying pool, what each criterion costs, and the sites that can reach the patients. Nothing to install and nothing to staff.
We have one trial and a small team. Is this too heavy for us?
No. It is built for exactly that. You send us the protocol and we do the work; there is no software to run and nothing to staff. You get the finished answer in days: how many patients actually qualify, which sites can reach them, and why. Clinical answers, not a tool for a two-person clinical operations group to learn. Book a preview →
Can you help before the protocol is final?
Yes, and that is the best time. We measure what each eligibility criterion costs in qualifying patients, so you can see where the protocol can safely open up and where it should not move. In a recent rare-disease program that nearly tripled the qualifying pool with the same scientific intent. Read the case study →
Our CRO handles site selection. Where do you fit?
As the check before you commit. Sponsors use us to check a proposed site list against the real patient record before activation dollars are spent, and the evidence works alongside whatever CRO you run with. It is your runway; this is how you protect it.
How do you protect our protocol and data?
Your protocol and study details stay yours. Every analysis is scoped to your engagement, runs on our own sourced evidence, and is never pooled with another client’s work. You receive the outcome, a ranked site list and the reasoning, never raw patient data, and the underlying record is de-identified by design. The honest boundary →
What do we actually get back?
A ranked, explained site list, one page per site: the site and principal investigator with contacts and startup readiness, the qualifying patient counts for the site and its investigator, a measured enrollment track record, and why each site made the list and why some marquee names did not. It is the answer to the question your board will ask: will it enroll? See the deliverable →
Do you use real-world data before the protocol is locked?
Yes. The Protocol Stress Test uses real, patient-level real-world data to count how many patients would qualify under the draft criteria, so you can go ahead as written or change the protocol with the numbers in front of you.
Book a preview and see the stress test on a real program. Then send the draft protocol and get the same read on your own trial, in days, before you commit the runway.