Trial budgetUpdated September 27, 2026

Where clinical trial budget actually goes

A small early-phase trial typically runs from the low hundreds of thousands of dollars into the low millions, and a pivotal Phase 3 trial can run into the tens of millions. Sites, monitoring and staff time drive most of it, not the software.

  • Site fees are the biggest line item
  • Software is usually a small fraction
  • Setup fees and slow builds still add up

Free sandbox · No credit card · 21 CFR Part 11 aligned

Task · Daily Evening Diary

Completed by

ParticipantSite coordinatorCaregiver

Completed on

PhoneHome tabletClinic devicePaper

Repeats

DailyWeeklyEvery X days

Participant instructions

Complete before bed each evening.

Site instructions

Review missed entries at each visit.

$100K+

typical floor for a small early-phase trial

$10M+

typical floor for a pivotal Phase 3 trial

3

biggest cost drivers: sites, monitoring, staff time

0

setup fees on Capture

The breakdown

Sites, monitoring and time, not software, dominate the budget

Per-participant site payments, CRA monitoring visits and travel, lab costs and staff time make up most of a trial's cost. Software is a real cost, but usually a small fraction of the total, so the more useful question for most sponsors is not which EDC is cheapest, but which setup gets the study running with the fewest people and the least delay.

  • Site fees per participant, scaling with trial size
  • CRA monitoring visits, travel and remote SDV coverage
  • Lab costs and internal or CRO staff time
  • Protocol amendments that require re-training sites
EDC procurement checklist
AI Study Generator
phase2_protocol_v4.pdfStep 2 of 3
  • Reading protocol
  • Building visits and windows
  • Drafting forms

11

visits

9

draft forms

2

diaries

The software line item

Where EDC pricing quietly adds cost

Setup fee
Charged separately from the license
None
Implementation time
Weeks to months before a site can start
Build and test the same day, free
Pricing model
Per-user or per-form, scales with team size
One plan for a live study
Evaluation
Sales call required to see the product
Free sandbox, no card, no call needed

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Before you switch

What to check before moving your budget

Cost

No setup fees and no long contract. You pay for a plan once the study goes live, not to evaluate it.

Compliance

21 CFR Part 11-aligned controls, audit trail and e-signatures are included, not sold as a separate compliance package.

Setup time

Most teams have a working draft study within an afternoon, which removes weeks of implementation from the schedule.

Migration

Bringing over an existing protocol or paper CRFs does not require a separate implementation project.

Support

Email support and documentation are included on every plan, with dedicated support available on Enterprise.

FAQ

Questions teams ask before they switch

Something not covered here? Ask us directly.

How much does a small biotech clinical trial cost?

Early-phase, single or few-site trials commonly run from the low hundreds of thousands of dollars into the low millions, driven mostly by site fees, monitoring and staff time.

How much does a Phase 3 trial cost?

Pivotal, multi-site Phase 3 trials commonly run into the tens of millions of dollars, scaling with the number of sites, participants and trial duration.

Is EDC software a big part of the trial budget?

Usually not. Software is a real line item, but site payments, monitoring and staff time dominate most trial budgets. Where software affects cost most is setup fees, implementation time and how much manual work it creates.

Can I lower trial costs without cutting corners on data quality?

Yes. The most common places to save without cutting quality are avoiding software setup fees, cutting time-to-first-site with self-serve setup, and reducing manual query resolution with automated edit checks.

Does a free EDC sandbox actually save money?

It removes the cost and time of evaluating software through a sales cycle, and lets you test the real build before any spend, which shortens the time to your first site.

See the real setup, not a quote

Free sandbox with every feature. No credit card, no sales call.

See the free sandbox