The honest answer is a formula, not a number. A 100-participant study is small enough that fixed costs dominate, so the build, the modules and your amendments matter more than the headcount. Here is the worksheet to price it yourself.
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Participants
100
Sites
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Months live
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The short answer
Why a formula
Searching for the cost of an EDC for a 100-patient trial returns ranges, and the ranges are wide for a reason. Two studies with the same 100 participants can differ by an order of magnitude in what they pay, because participants are rarely the main driver. The drivers are how many unique case report forms you need, how many sites enter data, how long the study stays live, which modules you add, and how often the protocol changes.
Most EDC is sold through a sales cycle and priced per deal, so a public price list almost never exists. That is why our EDC software pricing guide for 2026 describes market tiers rather than a rate card, and why this page gives you a way to compute your own number. The aim is that you walk into the first vendor call already knowing which lines should appear on the quote.
Scale also works against small studies. A fixed build fee spread over 1,000 participants disappears; spread over 100 it is a visible share of the budget. The same is true of validation work and project management. If your trial is small, the question to ask is not what the per-participant rate is, but how much of the quote is fixed cost you pay before the first participant is enrolled.
The lines
Use this as the checklist when you compare quotes. A line that is absent from a quote is either included, priced elsewhere or about to appear as a change order.
| Cost line | How it is usually priced | What to ask |
|---|---|---|
| Study build | Per unique form or as a fixed fee, before enrolment | Is it fixed, and does it include edit checks and the visit schedule? |
| Licence or platform fee | Per study, per month live, or annual | What happens to the fee if enrolment runs late? |
| Per-participant fee | Per enrolled or per active participant | Does a screen failure count as a participant? |
| Per-site fee | Per activated site, often one-off plus monthly | Is there a fee to add a site mid-study? |
| User seats | Per named user, per month | Do monitors, auditors and read-only users count? |
| Add-on modules | ePRO, eConsent, randomization, safety sold separately | Which of these does the study need on day one? |
| Amendments | Change order, hourly or per form | What does one added visit or field cost, and how long does it take? |
| Validation and support | Package fee or percentage of licence | Is a validation package mandatory? |
| Close-out and archive | Database lock, export, archive fee | Is your data export free at the end? |
Capture has no setup fee, no per-site fee and no per-seat licences, and EDC, eCRF builder, ePRO, eConsent and randomization are one platform rather than separate modules. Pricing for live studies is not published on this site.
The worksheet
Do this in a spreadsheet before the first vendor conversation. Every input is yours; nothing here is a price.
List every case report form the protocol needs and every visit it is collected at. Forms are the unit most build fees are quoted on. For a typical early-phase study this is a dozen or two, not hundreds.
Months live equals enrolment months plus follow-up months. A study that enrols 100 participants over 12 months and follows each for 6 is live for about 18. Any monthly fee multiplies by this number, which is why slow enrolment is expensive on a time-based licence.
Decide whether you need ePRO diaries, eConsent and randomization. If a vendor sells each separately, each adds a licence line and often a separate build line.
Plan for at least one amendment. Tufts CSDD found that 57% of protocols have at least one substantial amendment. Ask what one costs and how long it takes, then enter that as a line, not as a hope.
Total cost divided by 100 is your cost per participant. Compare that figure across quotes, but compare the fixed share too: build plus validation plus close-out, as a percentage of the total.
Three study shapes
These are structural sketches, not quotes. They show which lines grow, so you can place your own study.
One site, a handful of forms, a short follow-up. Per-site and per-seat charges barely matter because there is one site and a few users. The build fee and any minimum platform fee are the whole story, which is where the industry range for small studies applies. This is the shape where a no-setup-fee platform changes the maths most, because there is no large fixed line left to spread over 100 people. See EDC for under 100 patient trials for how a study this size is usually set up.
Five sites means five activations and perhaps twenty users. On a per-site and per-seat model, this is where the quote starts to grow faster than the participant count. Ask whether adding a site mid-study costs extra, and whether monitors and read-only users are counted as seats. On Capture there is no per-site fee and no per-seat licence, so adding a coordinator or a site does not change the bill.
Add patient diaries, remote consent and a randomization list and a modular vendor adds three licences and three builds. This is the shape where stitching several vendors together costs the most, in fees and in reconciliation time. A single platform removes the integration work. Our affordable EDC systems page covers what lean teams should look for here.
What changes
Build the 100-participant study in the free sandbox, with every feature, no credit card and no time limit. Pay only once it is live.
Per participant
Cost per participant is the metric buyers and grant reviewers ask for, and the easiest to distort. A vendor that charges a high build fee and a low per-participant rate looks cheap at 5,000 participants and expensive at 100. A vendor with no build fee and a per-participant rate looks the opposite. Neither is better in the abstract; what matters is your enrolment.
Also separate cost per enrolled participant from cost per participant visit. Two studies with the same 100 participants can have 600 or 2,000 completed visits, and every extra visit is more data entry, more queries and more monitoring. The calculator reports both, which makes it easier to see whether a quote scales with the work or only with the headcount.
Finally, keep software cost in proportion. For the full picture of where a trial budget goes, read how much a clinical trial costs: sites, monitoring and staff time usually dwarf the software line. EDC is the line you control most easily, which is why hidden fees and change orders on it are worth hunting down.
Before you sign
Get it as a fixed number, in writing, with the scope of forms and checks it covers.
Ask whether monitors, auditors and read-only users are charged.
If the licence is monthly, ask what a three-month delay adds.
Ask for the price and turnaround of adding one visit and five fields.
List ePRO, eConsent, randomization and safety and ask for each line.
Confirm a full export with audit trail at the end is included.
Reduce the risk
The single biggest source of surprise cost is the gap between the build you imagined and the build you needed. When a vendor builds the study, you discover the gap in user acceptance testing, and closing it is a change order. When your own team builds in a sandbox, you discover it on day two and fix it for free.
In Capture you can upload a protocol and let AI draft the visits and forms, then review every field before anything is saved, add edit checks and enter sample data, all in the free sandbox. Start from the free trial and bring a real number back to your budget.
It depends on forms, sites, months live, modules and amendments rather than on the participant count alone. Commonly cited industry pricing research puts small single-site deals at roughly $10,000 to $50,000, with implementation overhead on top. Use the line-item worksheet on this page or the EDC cost calculator to price your own study.
Divide the total EDC cost by the number of enrolled participants. Small studies often look expensive per participant because fixed costs such as build and validation are spread over few people. Compare the fixed share of each quote, not just the per-participant figure.
No. Capture has no setup fee, no per-site fee and no per-seat licences. You build and test the study free in the sandbox and pay only once it is live with real participants.
The sandbox includes every feature with no credit card and no time limit. You can build a full study, enter sample data and test edit checks, e-signatures and the audit trail before going live.
They price different things: some charge a build fee, some per participant, some per site or per seat, and many sell ePRO, eConsent and randomization as separate modules. A line-item comparison is the only reliable way to compare them.
Reserve an explicit line. Tufts CSDD found that 57% of protocols have at least one substantial amendment. With a vendor-built EDC each one is usually a change order; in Capture your own team edits forms and visits without one.
Capture does not publish a price list. The terms are simple: no setup fee, no per-site fee, no per-seat licences, free sandbox, and payment only once the study is live. Build your study in the sandbox and talk to us when you are ready to go live.
Keep exploring
EDC cost calculator
Price your own study line by line.
EDC software pricing guide (2026)
The market tiers behind these ranges.
EDC for under 100 patient trials
Setting up a study this size.
Affordable EDC systems
What lean teams should look for.
Clinical trial software without setup fees
Why setup fees exist and how to avoid them.
How much does a clinical trial cost
Where the whole trial budget goes.
Build the study free, with every feature. No credit card, and you pay only once you go live.