PRACTICAL GUIDE | 2026

What Your CRO Needs to Quote Your First-in-Human Study: The Sponsor's Pre-Quote Checklist

A precise quote is built, not guessed.

By Julio G. Martinez-Clark

CEO, bioaccess®

Last verified: September 2026 | General information only—not legal or regulatory advice. Rules change frequently; confirm the strategy with qualified regulatory counsel.

Publishing package

'Just give me a ballpark.' Every CRO hears it. Here is the honest answer bioaccess® gives: a rough quote from the synopsis alone is fine — precision needs the full package. What your CRO needs to quote your first-in-human study is not a secret; it is three inputs, each unlocking a different level of accuracy.

This post is written to be sent to every prospect who asks for a fast quote. If you are that prospect, work through the checklist below and both sides will save weeks.

What are the three inputs — and what does each one unlock?

Input	What it is	What it unlocks
1. Protocol or synopsis	The study design: objectives, population, endpoints, treatment, follow-up.	A rough range. Enough to say whether the study is a $300k program or a $1M program — not enough to price it.
2. Schedule of events	Visit by visit: what happens at each contact, which assessments, which procedures, how many visits, over what duration.	The line-item structure. Site costs, monitoring visits, lab and imaging pass-throughs, and CRO effort all derive from this table.
3. Feasibility questionnaire answers	Patient type, planned activities, visit structure, patient count, site preferences, timelines — the operational facts the protocol implies but never states.	A precise quote. This is where assumptions die and real numbers appear.

Why is the schedule of events the input that matters most?

Because everything billable hangs off it. The schedule of events answers the questions a synopsis never does:

• How many site visits per patient — which sets site payments and monitoring visit counts.
• Which procedures happen where — which sets hospital fees, lab costs, and imaging pass-throughs.
• How long follow-up runs — which sets the CRO's management duration and data-management scope.
• What the staff must do at each visit — which sets coordinator and investigator effort.

Two synopses can describe similar-looking studies with radically different schedules of events — and radically different budgets. Quoting from the synopsis alone means guessing all of the above. An honest CRO will tell you it is guessing; a dishonest one will present the guess as a quote.

What does the feasibility questionnaire cover?

The customized feasibility questionnaire converts the protocol into operational facts. Expect questions on:

• Patient type. Indication, severity, inclusion/exclusion profile — who exactly must be found, and how hard they are to find.
• Activities. What the sites and the CRO must actually do: procedures, assessments, device handling, training, proctoring.
• Visit structure. Number, spacing, duration, and location of visits — site, hospital, or remote.
• Patient count. Target enrollment and any cohort or staging structure.
• Timelines and constraints. When you need first-patient-in, and what cannot move.

Answering this questionnaire is also the fastest way to qualify yourself as a serious prospect. Sponsors who answer it get precise quotes. Sponsors who will not answer it get ranges — and should be suspicious of any CRO that offers more.

What should a good FIH quote show you?

Once the inputs are in, judge the quote by its structure. A serious FIH quote has three buckets:

1. Site costs. Investigator and hospital payments per the schedule of events. These are pass-throughs negotiated at the clinical trial agreement — the CRO should show them transparently, not bury them.
2. CRO professional fees. Project management, monitoring, regulatory, data management. This is the bucket with flexibility — it is what the CRO controls.
3. Third-party pass-throughs. Labs, imaging, couriers, translations, EDC hosting. The CRO does not control these costs but should influence them through negotiation — and every one should be auditable against invoices.

Two more honesty tests: the quote should state its assumptions explicitly (patient count, visit numbers, timelines), and it should require an advance payment to start work — standard in the industry, because startup costs are real and immediate. A quote with no assumptions and no advance is not a quote; it is a marketing document.

The sponsor's pre-quote checklist

Before you ask any CRO for a number on your first-in-human study, assemble this package. It is the difference between a quote you can budget against and a conversation you will have twice.

1. Protocol or detailed synopsis. Final if you have it; near-final with flagged open points if you do not. Flag what is still changing — it affects the quote's shelf life.
2. Schedule of events. Visit-by-visit table: assessments, procedures, and timing for every patient contact from screening through last follow-up.
3. Patient count and cohort structure. Total enrollment target plus any dose-escalation or staged-cohort design.
4. Patient type definition. Indication, key inclusion/exclusion criteria, and any recruitment constraints you already know about.
5. Target timelines. When you need startup complete and first-patient-in — and which date is real versus aspirational.
6. Country preferences or constraints. Any markets already chosen or ruled out, and why.
7. Budget signals. A range you need to land in is not a weakness; it lets the CRO design to it or tell you honestly that it cannot be done.
8. Decision process and timeline. Who decides, and when. It focuses everyone's effort where it matters.

Frequently asked questions

Can you give me a ballpark quote from just the synopsis?

Yes — a rough range, honestly labeled as one. Precision needs the full package: protocol or synopsis, schedule of events, and feasibility questionnaire answers. Treat any 'precise' number built from a synopsis alone as fiction.

Why do you need the schedule of events to quote accurately?

Because every cost line derives from it: site payments, monitoring visits, hospital and lab pass-throughs, and CRO effort. Two similar synopses can hide very different schedules of events — and very different budgets.

What is the feasibility questionnaire for?

It converts the protocol into operational facts: patient type, activities, visit structure, patient count, and timelines. It is also where unrealistic assumptions surface before they become contract disputes.

How long does a precise quote take once we send everything?

That depends on the CRO and the study's complexity — but the clock starts when the full package arrives, not when the first email was sent. Sending a partial package and asking 'how much longer' restarts nothing; it just delays the start.

Should we get quotes from multiple CROs?

Yes — and give every CRO the same package. Quotes built from different inputs are not comparable, and the cheapest number built from the thinnest inputs is usually the most expensive study.

What if our protocol is still changing?

Say so upfront. A good CRO will quote against the current version, flag the assumptions, and tell you which changes would move the number. Quoting against a moving protocol without flagging it helps no one.

Send the package, get a number you can use

What your CRO needs to quote your first-in-human study is the full package: protocol or synopsis, schedule of events, and feasibility answers. Send bioaccess® yours and you will get a structured, three-bucket quote with explicit assumptions — a number you can take to your board.

Talk with bioaccess® about your Latin America FIH strategy

Regulatory references

• bioaccess® blog: First-in-Human Trial Budgets in Latin America: What the Money Actually Buys — and Where You Can Cut (2026).
• bioaccess® blog: First-in-Human Clinical Trial: What Happens in Each of the Nine Workstreams (2026).
• bioaccess® blog: How We Qualify FIH Sites and Investigators in Latin America (2026).
• ICH E6 Good Clinical Practice (GCP).