You asked for a trial that enrolls on your clock
A synopsis in the format your team writes every week. What the study needs, what we run, and the one number everything else hangs on.
"We can't afford a Phase II that enrolls at the industry's pace. Every month of slip comes straight out of the runway we need for the Phase III decision."Kelvane RFP, section 4.2, September 2026
What we heard
A well-designed protocol, a strong safety package from Phase I, and a fixed amount of cash. The science is ready. The risk is the calendar.
What we're proposing
Full-service management of KLV-204 across 16 US sites, half of them from Quillmark's own headache network, with recruitment running before the first site opens.
| Study | Phase II, randomized, double-blind, placebo-controlled, three arms |
|---|---|
| Population | Adults with episodic migraine, 4 to 14 migraine days a month |
| Sample | 320 randomized, about 800 screened |
| Per patient | 28-day diary run-in, 12 weeks of treatment, 4 weeks of follow-up |
| Primary endpoint | Change in monthly migraine days, captured in a daily eDiary |
| Quillmark scope | Start-up, sites, monitoring, recruitment, data, safety, statistics, report |
Protocol KLV-204-201, version 2.1, as shared under CDA on 12 September.
Every figure on this page comes from one model. Change the sites in 2.0 and the price, dates and payments follow.
Move the sites. Watch the date move.
This is the model we'd run the study on. Switch candidate sites on or off and set the screening pace. The curve, the last-patient date, the contract and your runway all redraw from the same numbers.
Patients screened per site each month. About 4 in 10 randomize after the diary run-in.
Switch at least one site on to run the forecast.
Milestone payments
Quillmark is paid when the study moves. Dates and amounts redraw with the forecast and with the budget in 8.0.
| Milestone | Share | Forecast date | Payment |
|---|
Twenty weeks, from the patient's side of the table
Step through one patient's path through KLV-204. On the left, what she experiences. On the right, what Quillmark is doing while she does.
Speed that never borrows from safety
Fast enrollment worries a CMO for a good reason. It's how sites cut corners on eligibility. Here's how we keep the pace and the protocol at the same time.
Every randomization in KLV-204 passes a second eligibility check by a Quillmark medical reviewer before the first dose ships. It adds about a day per patient. It's the reason our Phase II studies run with low eligibility deviation rates, and it's the line we'd defend hardest in any budget conversation.
A serious adverse event reaches Kelvane's safety lead, with Quillmark's medical monitor's first assessment attached.
Any eligibility question at a site gets a written answer from a Quillmark neurologist. Sites don't guess.
Blinded safety listings to you, with diary compliance by site so a slipping site shows up early.
Full support for the independent safety committee, including the unblinded statistician kept separate from the study team.
Who your medical monitor is
The second eligibility check costs about $41,000 across the study. It's inside medical monitoring in 8.0.
Which sites, and what happens when one stalls
Half the plan runs through sites Quillmark already works with. The other half is chosen for patient population. And none of them is allowed to stall quietly.
Headache centers on Quillmark's master agreements. Contracts pre-agreed, so they open about eight weeks sooner.
Chosen from referral data for episodic migraine density, with a coordinator who's run an eDiary study before.
Pre-qualified and contracted, unopened. We can activate either inside 30 days.
If a site randomizes fewer than two patients in any 60 days after its third month, we sit down with you, agree a fix within ten working days, and if it doesn't recover we close it and open a rescue site. You never have to ask.
How we recruit before sites open
Network sites carry an N on the map in 2.0. They're the reason the Quillmark curve starts two months earlier than the dashed line.
What you pay, when, and who carries a slip
One exact contract value, paid in eight milestones that only fall due when the study moves. If enrollment slips on our side, Quillmark pays for it.
From the operating budget you shared. A month of slip in enrollment is a month of this, plus our project fees.
If last patient in comes more than 60 days after the date we commit to at signing, for reasons in our control. Capped at $570,000.
Investigator grants are billed at cost, monthly, against visits completed, and sit outside the contract total. Everything else is in 8.0, line by line, and every line can come out.
What counts as "in our control"
The payment table in 2.0 always shows the current total, so it's the schedule you'd sign.
Ready for an inspection from the first site visit
An FDA inspection is a review of the paperwork you kept along the way. So we keep it as if the inspector arrives next week.
- Trial master file filed within five working days of each documenttarget 95 percent
- Every eDiary entry carries its own audit trail, timestamped at the devicePart 11
- Risk-based monitoring plan agreed with you before the first site opensmonth 2
- Your quality team gets read access to the TMF and the monitoring reportsfrom day one
- A mock FDA inspection at two sites and at Quillmark, before database lockoptional, 8.0
Audits of Quillmark
Sam's audit rights are written into the terms in 10.0 in the same words.
Every line priced, every line optional
The same core study in every version. Switch a line off and it tells you what changes. Site count and project months come from the forecast above.
We'd keep the rescue sites and the mock inspection. They're the two lines that protect the date and the filing, and together they cost less than two weeks of Kelvane's burn. Spanish-language recruitment earns its place while Miami and Houston are in the plan. If you switch those sites off, drop it too.
Twenty-six months, plotted
The engagement from signature to final report, drawn from the same forecast. Month 0 is January 2027.
The terms, in plain language
The master services agreement says all of this at greater length. This is what it means.
Price
One fixed fee for the scope in 8.0. Changes only by a written change order that both sides sign.
Payment
Eight milestones, invoiced when each one is reached, due in 45 days.
Grants and pass-throughs
Billed monthly at cost with receipts. No markup.
Enrollment credit
$95,000 a month if last patient in slips past 60 days of the committed date for reasons in our control. Capped at $570,000.
Audits
One routine audit a year at no charge, and for cause at any time.
Data
All study data and documents belong to Kelvane from the moment they're created.
Team
Your project lead and medical monitor are named at signing. We don't swap them without your agreement.
Ending early
Either side can end it with 60 days' notice. You pay for work done and wind-down, nothing more.
Full MSA and work order go to your counsel on acceptance. Nothing in them contradicts this page.
What we don't know yet
Three things could move the plan. We'd rather you see them now.
Will the FDA want the higher dose arm kept after the interim look?
If the protocol adds an arm, the sample grows and the forecast moves. We've modeled it and can show you the change in a day.
Owner, Maren and Sam · after your Type C meetingWhich eDiary vendor will you use?
We've priced our standard device. If you've already contracted a vendor, the data line comes down by about $300,000 and we'd integrate with theirs.
Owner, Theo · before signingHow fast can drug supply follow a new site?
The forecast assumes kits reach a new site within ten days of activation. If your packager needs longer, sites open later and the date moves with them.
Owner, Kelvane CMC · week 2