The Program
From Zero to Trial-Ready
in Six Weeks.
I am building this program right now, so details may change between today and the first session. The structure below will remain the same. The order of a topic or two might not. If that bothers you, clinical trials will be a difficult experience.
Curriculum
Your trial, your assumptions, your critical path.
We start with the uncomfortable part: writing down what you actually know about your trial versus what you are hoping. Indication, design, patients, sites, dates, and underneath it all, the assumptions holding everything up. Then we build your critical path from today to data readout so you can see which delays would just be annoying and which would be expensive or existential.
A protocol that survives contact with real patients.
The science can be excellent and the trial still impossible. We map the patient journey visit by visit: the travel, the procedures, what a real person with this condition will actually tolerate. We look at where protocol amendments come from and which decisions to pressure-test before anything gets finalized.
Enrollment and sites, or where trials actually fail.
Where your patients are, how to select sites on more than the KOL's reputation, and how to ask feasibility questions that produce honest answers instead of polite optimism. Every site will tell you they have the patients. We build your enrollment forecast with triggers, so when a site delivers nothing by month three, you already know what happens next.
Outsourcing: what to keep, what to hand over, what it should cost.
Function by function, we work out what stays in-house and what goes out, based on what you have, what the data is for, and what you can realistically manage. You learn how vendors are selected, how they price, and how to run a selection process where you are the one asking the questions. I spent nine years inside a CRO and I know what they offer.
Running your vendors, and running yourselves.
Signing the contract is where oversight begins, not ends. KPIs, meeting cadence, escalation paths, and change order discipline: how to read one, when to push back, and how to prevent the next one. Then the sponsor side of the mirror: your minimal team, who owns what, and the operating rhythm that keeps a trial moving without heroics at midnight.
Budget, risk, and the pressure test.
A budget skeleton with the true cost drivers exposed, built to receive vendor quotes without falling over. Your risk register, assembled from everything the previous five weeks flagged. Simple reporting that tells you the state of your trial at any moment.
Working Assets
Along the way you collect the working assets I am building for this program, around 20 of them. A few, to give you the flavor:
- The questions functional experts wish founders asked about their own trials, collected from the people who work in the trenches. Their scar tissue, your head start.
- A site feasibility questionnaire designed to get past site optimism. Ask "can you enroll" and every site says yes. There are better questions.
- An enrollment forecast model with built-in trigger points, so underperformance becomes a decision, not a slow surprise.
- Essential documents list for site activation per latest GCP ICH
- A budget skeleton that shows you your cost drivers before any vendor shows you their price.
- My watch-out lists: the failure patterns from twenty-plus trials, sorted by where in the journey they ambush you.
Limited Seats
Join the Waiting List
Cohorts are kept small by design. Add your name and I'll reach out to see if the Program is a fit for you. A seat is 10,000 EUR.
Joining the list is not a commitment. I'll reach out, we'll talk, and you'll decide.