Phase 3Updated September 27, 2026

An EDC that scales to Phase 3, without the enterprise setup

Phase 3 means more sites, more participants and a pivotal data set. Capture keeps every site on one locked form version, one randomization design and one audit trail, built the same self-serve way as a smaller study.

  • Multi-site by design
  • One audit trail across every site
  • No months-long implementation

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

Day 25Target: day 28Day 31

Window -3 / +3 days around the anchored target date

Soft window

Stays available with a protocol deviation flag

Hard window

Locks outside the window

Warning only

Stays available with a warning

Auto-close

Marked missed when the window closes

1

audit trail across every site

0

months of implementation before you can start building

4

arms supported by the built-in randomization design

0

setup fees

What changes at Phase 3

The build gets bigger. The setup should not.

A pivotal study adds sites, participants and scrutiny, not necessarily complexity in the software itself. Capture keeps the same visual study builder for a 5-site Phase 3 study as a single-site Phase 1, with the coordination features multi-site work actually needs.

  • Site-specific or study-wide QR enrollment, no app install
  • Site-level participant numbering and a separate coordinator portal per site
  • Approved forms locked and shared identically across every site
  • By-site and by-date exports for interim looks
Participant funnel
Identified40
Consented31
Enrolled26
Randomized22

Site risk

Site 03 needs attention

Action items

2 overdue

Allocation

Randomization built into enrollment

Set your arms, block size and stratification once at study setup. Allocation happens automatically the moment a participant is enrolled, the same way at every site.

  • Block randomization with configurable block size
  • Stratification by site or another factor
  • Every allocation logged in the same audit trail as the rest of the study
Schedule · arms, epochs and locations
ScreeningTreatmentFollow-upSCRD1D14D28D84EOSLocationOn-siteOn-siteRemoteHomeRemoteOn-site
Arm A
Arm B

Day 28 is an Arm B only visit, so Arm A participants never see it.

Data quality at scale

Queries that do not wait for a monitoring visit

A pivotal data set cannot wait weeks for a monitor to catch a bad value. Edit checks raise auto-queries the moment a site enters something that breaks a rule, across every site at once.

  • Range, custom-value and priority-based edit checks
  • Auto-queries appear in the site's action list immediately
  • Field-level audit trail: who changed what, when, and why
Query management software
Vital signs · Systolic blood pressure

Edit checks / auto-queries

2
Auto-query

Type

Range High

Operator

Greater than

Value

180

Priority: High

Auto-query

Type

Range Low

Operator

Less than

Value

80

Priority: Normal

Query raised automatically

Value 192 violates limit (180). Please verify.

Model your Phase 3 build before a single site goes live

Add sites, forms and a randomization design in the free sandbox. Nothing is live until you say so.

Build your Phase 3 study free

Before you switch

What sponsors check before moving a pivotal study

Cost

No per-site or setup fees. Pricing applies once the study goes live, not to adding sites during the build.

Compliance

21 CFR Part 11-aligned controls, field-level audit trail and verified e-signatures apply the same way at every site.

Setup time

Sites are added by inviting a coordinator and sharing a QR enrollment link, not by rebuilding the study.

Migration

Moving an existing Phase 2 build forward, or starting fresh for Phase 3, both use the same visual study builder.

Support

Email support and documentation for every plan; Enterprise adds dedicated support and validation assistance.

FAQ

Questions teams ask before they switch

Something not covered here? Ask us directly.

Can Capture support a multi-country Phase 3 trial?

Capture hosts data in the EU (Frankfurt) or US (N. Virginia), chosen at study setup. Multi-site coordination features work the same across sites regardless of country; confirm your specific regulatory submission requirements separately.

How many sites can one study support?

There is no hard site limit in the platform. Each site gets its own coordinator portal and participant numbering under the same study.

Does every site see the same version of a form?

Yes. Approved forms are locked for live use and shared identically across every site, so there is no drift between sites after an amendment.

How does randomization stay consistent across sites?

The randomization design, arms, block size and any stratification factor, is set once at study setup and applied automatically at enrollment, the same way at every site.

Can I pull data for just one site during monitoring?

Yes. Exports can be filtered by site and by date range.

Is there a setup fee to add sites during the trial?

No. There are no per-site or setup fees. Adding a site means inviting a coordinator and sharing an enrollment link.

Build your Phase 3 study free

Model the full multi-site build in the sandbox before any site goes live.

Build your Phase 3 study free