Clinical Trial EDC Cost Calculator

EDC (electronic data capture) for a single clinical trial typically costs anywhere from the tens of thousands of dollars for a small single-site study on a budget tool to well over a million dollars for a multi-country Phase 3 on an enterprise suite with ePRO and randomization. For the Phase 2 example loaded in the calculator (8 sites, 120 participants, 20 live months, ePRO, eConsent and randomization), a mid-market vendor comes to about $269,954, or $2,250 per participant.

The total is never one number on a price list. EDC pricing is assembled from a dozen separate fees, and the mix depends on who builds the database, how many sites and participants you have, how long the study stays live, which modules you add and how often the protocol changes. That is why two quotes for the same protocol can differ by a factor of three, and why a realistic EDC budget has to be built line by line.

Typical total cost of ownership for one study, modelled with the benchmark rates in the methodology section. Each preset in the calculator reproduces a row, so you can open it and change any input.

Before you can compare EDC costs you need to know which pricing model each vendor uses, because the same study can look cheap under one model and expensive under another. Most quotes combine several of these:

Per-study licence

A fixed licence for one protocol, often with a minimum term. It is predictable, but it usually excludes the build, the modules and the change orders, which is where most of the money goes.

Per-patient (per-subject) pricing

A fee for every enrolled participant, sometimes tiered by volume. Per-patient EDC pricing scales fairly with study size, but watch for minimums that make small studies expensive and for separate per-patient fees on each add-on module, such as ePRO devices or eConsent.

Per-site fees

An activation fee for every site (often bundled with training) and sometimes a monthly maintenance fee per site. Per-site fees punish exactly the thing that speeds up enrollment: adding sites.

Per-CRF-page or per-data-point pricing

Older models charge by the volume of data collected. They make long, data-heavy protocols hard to budget and quietly reward collecting less data rather than the right data.

Per-user (per-seat) licences

Every investigator, coordinator, monitor and data manager needs a named login. Seats look cheap individually but compound across sites and months: the Phase 2 example has 28 users over 20 months.

Subscription (SaaS) pricing

A recurring fee for the platform while your study is live, typically sized to the study. Self-serve SaaS platforms usually fold the build tools, modules and changes into the subscription because the study team does the building, which removes the setup fee and change orders entirely.

Enterprise and portfolio licences

Large sponsors negotiate multi-study agreements with committed volume. Unit prices drop, but implementation, validation and integration projects are quoted separately and can run for months.

Open-source and self-hosted EDC

The licence may be free, but you pay in hosting, upgrades, security, system validation and the staff to run it. For regulated studies the validation effort alone can exceed a commercial subscription. See build vs buy EDC for the full trade-off.

These are the cost drivers the calculator prices individually. Use them as a checklist when you read a vendor proposal: anything not listed is either included, excluded or waiting to appear as a change order.

Study build / setup fee

Protocol review, database specification, eCRF programming, visit schedule and edit checks. Usually priced by the number of unique forms and the complexity of the edit checks, and paid before first patient in.

Validation and UAT package

Validation documentation, test scripts and user acceptance testing support so you can show the system does what it should under 21 CFR Part 11 and ICH-GCP.

Platform licence and hosting

The recurring fee for the software and the infrastructure it runs on, charged monthly or annually for as long as the study is live.

Site activation and site fees

Per-site set-up, training and access provisioning, sometimes plus a monthly fee per active site.

Per-participant fees

A charge for each enrolled participant, which is how many vendors scale price with study size.

User licences

Named seats for site staff, monitors, data managers and sponsor users.

Vendor project management

A monthly fee for the vendor project manager who runs the build, the change orders and the status meetings.

ePRO / eCOA module

Patient questionnaires and diaries, often with its own setup fee, monthly fee and per-patient device or licence fee.

eConsent module

Electronic informed consent with e-signatures, frequently sold as a separate product.

Randomization (IRT / RTSM)

Arm assignment, stratification and, for drug studies, supply management. Among the most expensive modules when bought separately.

Integrations

Connecting separate systems (EDC to ePRO, EDC to IRT) and reconciling the data between them.

Change orders

Every protocol amendment that touches forms, visits or edit checks: new specification, programming, testing and redeployment.

Database lock, exports and archive

Final data cleaning support, locked datasets, and an archive copy for the trial master file after the study ends.

Phase 1 EDC cost

Phase 1 studies are small and short, so fixed costs dominate: the build fee, validation and project management can be most of the bill even with 20 to 40 participants. Fast cohort decisions also mean the database has to be live quickly and changed quickly between cohorts. This is where per-study minimums hurt most. More on EDC for Phase 1 trials.

Phase 2 EDC cost

Phase 2 adds sites, randomization and often ePRO endpoints, so module and per-site fees start to matter as much as the build. Phase 2 protocols are also amended often, so change orders become a real budget line. See EDC for Phase 2 trials.

Phase 3 EDC cost

Pivotal studies run for years across many sites and countries. Monthly fees, per-participant fees and seats multiply, and an enterprise ePRO and IRT stack can cost as much as the EDC itself. Small percentage differences in unit price become six-figure differences in total. See EDC for Phase 3 trials.

Medical device studies

Device studies often have long follow-up and fewer visits per year, so the time the database stays live drives cost more than visit count. Many also need patient-reported outcomes after discharge. See EDC for medical device trials.

Observational, registry and real-world evidence studies

Large enrollment and light forms mean per-participant fees dominate. Registries that run for years should be priced over their full life, not the first contract term. See EDC for observational studies.

Investigator-initiated and academic trials

Academic teams usually have the tightest budgets and the least vendor-management capacity, so self-serve tools and free sandboxes matter more than discounts. See EDC for investigator-initiated trials and Capture for academia.

The licence is rarely the expensive part. The hidden costs of EDC are the ones that do not appear on the first quote, or appear as “to be scoped”:

• Change orders and amendments. Every amendment that touches the database is re-specified, re-programmed, re-tested and redeployed at the vendor’s rate. In the Phase 2 example, 2 amendments add $18,000. See protocol amendments without change orders.
• Module creep. ePRO, eConsent and randomization are often separate products with separate setup fees, monthly fees, per-patient fees and validation.
• Integration and reconciliation. Separate systems mean data transfers, mapping specs and someone reconciling mismatches every week.
• Enrollment overruns. Monthly licence, site, seat and project-management fees keep running if enrollment is slow. The calculator shows your monthly run-rate so you can see what each late month costs.
• Minimums and term commitments. Per-study minimums and annual terms make short or small studies disproportionately expensive.
• Exit and archive fees. Locked datasets, audit trail exports and long-term archive copies can be billed at close-out. Ask what leaving costs before you sign.
• Internal staff time. Writing specifications, reviewing builds, running UAT and managing the vendor all take your team’s time, even when the vendor does the programming.

The 2017 Tufts CSDD eClinical Landscape Study found that it took an average of 68 days to build and release a study database, and 36 days after the last patient visit to lock it. The same study found that releasing the database after first patient first visit doubled the time from visit to data entry.

Those weeks are expensive. Tufts CSDD estimates the mean direct cost of conducting a Phase 2 or Phase 3 trial at roughly $40,000 per day, and about $500,000 per day in unrealised sales for a drug that reaches market. Even a small biotech burning $150,000 a month pays roughly $35,000 for every week the database is not ready.

The calculator values this separately from the software saving. In the Phase 2 example, a traditional build takes about 11.5 weeks against 2 weeks on Capture, so the study can go live 9.5 weeks sooner, worth about $328,846 at the default cost of delay. Set your own monthly figure under “Your quote and cost of delay”.

Sources: Tufts CSDD and Veeva, 2017 eClinical Landscape Study; Tufts CSDD, day of delay white paper (2024).

EDC return on investment is simple to state and easy to under-count. Compare the full cost of each option over the life of the study, then add the value of time:

Worked example. For the Phase 2 study above, the typical mid-market quote is $269,954. Capture’s estimated hard saving is about $210,000 (75% lower), the database goes live 9.5 weeks sooner (worth about $328,846 at $150,000 a month), and the 2 planned amendments are made by the study team without change orders, saving about 6 weeks of turnaround.

Two things make an EDC business case credible to a CFO or grant reviewer: use your own quote rather than a benchmark if you have one, and keep time value separate from hard savings so nobody has to accept both at once. The calculator does both.

1. 1

   Choose a self-serve builder. If your team can build and change forms itself, the setup fee and change orders disappear. That is usually the largest single saving.

2. 2

   Test before you buy. A free sandbox lets you build the real study and see whether it works before procurement, rather than paying for a build to find out.

3. 3

   Buy one platform, not four. EDC, ePRO, eConsent and randomization in one system removes three setup fees, three validations and every integration between them.

4. 4

   Start from templates. Standard forms (demographics, vital signs, adverse events, concomitant medications, labs) should not be programmed from scratch. Browse eCRF templates.

5. 5

   Draft the build from the protocol. AI-assisted study builders turn a protocol into a first draft of visits and forms in minutes. You review and approve; nothing goes live unreviewed. See the AI study builder.

6. 6

   Collect only what the endpoints need. Every extra form is build time, monitoring time and cleaning time. Fewer, better forms cost less in every pricing model.

7. 7

   Push edit checks to the point of entry. Range and consistency checks that fire when data is entered prevent queries instead of chasing them weeks later.

8. 8

   Avoid per-site and per-seat pricing. If adding a site or a monitor changes the price, your EDC is taxing the actions that speed up the study.

9. 9

   Plan for amendments. Most protocols change. Ask what an amendment costs and how long it takes before you sign, not after.

10. 10

    Price the whole study life. Compare total cost from build to archive, including close-out and exports, not the first-year licence.

11. 11

    Keep your data portable. Make sure you can export everything (data, audit trail, data dictionary) at any time without a fee, so switching is possible.

12. 12

    Go live sooner. Every week the database is not ready costs more than most licence discounts. Optimise for time to first patient in.

Paper CRF vs EDC cost

Paper case report forms have no licence fee, but the cost moves elsewhere: printing and shipping binders, double data entry, manual queries by fax or email, slower monitoring, and weeks added to database lock. There is also no real-time view of the data and no automatic audit trail. Beyond a very small pilot, paper is almost always the more expensive option once staff time is counted.

The true cost of free EDC

Free-to-license academic tools are excellent for many research projects, but a free licence is not a free study. Someone has to host it, maintain it, validate it if you need 21 CFR Part 11 controls, and build every form. Compare like for like in Capture vs REDCap and REDCap alternatives.

Capture takes a different route to the same goal: you can build and test the entire study in a free sandbox, with every feature and no time limit, and you only pay once you go live with real participants.

Send the same list to every vendor so the quotes are comparable. The EDC procurement checklist covers the rest of the RFP.

• What is the total cost for this exact protocol from build to archive, itemised by line?
• Is the study build quoted separately, and is it fixed price or time and materials?
• What does a protocol amendment cost, and how long from request to deployed change?
• Are ePRO, eConsent and randomization included, or separate products with separate fees?
• Are there per-site, per-user or per-participant fees, and do they have minimums?
• What happens to the price if enrollment runs six months late?
• Can we build and test the study before we sign?
• What validation documentation is provided, and is it included?
• Can we export all data, the audit trail and the data dictionary at any time, and is there a fee?
• What does close-out, database lock and archiving cost?

The calculator builds a traditional quote from the line items above using benchmark rates for three generic vendor classes. The rates are planning benchmarks drawn from the shape of typical EDC proposals, not the price list of any named vendor. If you have a real quote, enter it: the calculator treats it as your vendor’s price level, splits it into the same line items, and scales it with the study as you change sites, participants, duration or modules.

• The study is live for the enrollment period plus the time each participant stays in the study, plus 2 months for database lock and close-out.
• Users are 3 per site plus 4 sponsor-side users (project manager, monitor, data manager, medical monitor).
• Vendor build time is the base for the vendor class, plus one week per 15 unique forms and one week per module.
• Capture build time is a deliberately conservative one week plus one week per 50 forms, including your own review and UAT in the sandbox.
• Real quotes vary. The range shown runs from 80% to 135% of the modelled figure, skewed upward because quotes tend to grow during scoping.
• Savings compare the modelled or entered quote with what a study of the same size would pay on Capture, rounded down. Time value is shown separately and never added to the saving.
• Everything is calculated from the inputs you can see. Nothing you enter is stored.

EDC (electronic data capture)

Software for collecting clinical trial data on electronic case report forms instead of paper.

eCRF

Electronic case report form: one structured form in the EDC, such as vital signs or adverse events.

Study build

Turning the protocol into a working database: forms, visit schedule, edit checks and roles.

Edit check

A rule that flags an implausible or inconsistent value when it is entered, raising a query.

Change order

A billable request to change a vendor-built database after go-live, usually triggered by an amendment.

Protocol amendment

A formal change to the approved protocol, which often requires changes to forms or visits.

ePRO / eCOA

Electronic patient-reported (or clinical outcome) assessments: questionnaires and diaries completed by participants.

IRT / RTSM

Interactive response technology or randomization and trial supply management: the randomization system.

UAT

User acceptance testing: the sponsor checks the build works as specified before go-live.

Database lock

The point where data is final and frozen for analysis, after cleaning and sign-off.

TCO

Total cost of ownership: every cost of a system over the life of the study, not just the licence.

FPI

First patient in: the first participant enrolled, the milestone a slow build delays.

More definitions in the clinical research glossary.

Amendment figures: Tufts CSDD, protocol amendments study (2016). Last updated September 30, 2026.