Therapeutic areaUpdated September 28, 2026

EDC built for how rare disease trials actually run

Rare disease trials usually mean a small, geographically scattered patient population, a heavy reliance on natural history or registry data, and outcomes that are often reported by a caregiver rather than the patient. Capture's EDC, ePRO and registry-friendly data model fit that pattern without a rare-disease-specific price tag.

  • Registry and RWE study support
  • Caregiver-reported outcomes (ObsRO)
  • Single-site to multi-country, same platform

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

PRO

Patient-reported

Participant, own phone

ObsRO

Observer-reported

Caregiver

ClinRO

Clinician-reported

Site staff, clinic tablet

PerfO

Performance outcome

Site-run test, e.g. chair rise

4

eCOA types supported: PRO, ObsRO, ClinRO, PerfO

0

minimum patient count to build and test a study

EU + US

hosting regions for multi-country rare disease programs

Free

sandbox to test the full build before enrolling patient 1

Small, scattered populations

Built for a handful of sites, not a thousand-site program

A rare disease study rarely looks like a large Phase 3 program. It looks like a handful of specialist sites, sometimes across several countries, enrolling patients as they are identified rather than in one enrollment wave. Capture's per-site setup, QR-code enrollment and by-site data filtering work the same whether a study has 3 sites or 300.

  • Site-level participant numbering and a separate site coordinator portal, useful when sites are geographically scattered specialist centers.
  • By-site data filtering and exports for a coordinating center working across multiple countries.
  • EU (Frankfurt) and US (N. Virginia) hosting regions for multi-country programs.
Study landing page

Now recruiting

Sleep and Recovery Study

A 12-week study of sleep quality after surgery. Takes 5 minutes a day on your phone.

Check if you can take part
12 weeks5 min a dayNo app needed

Scan to join

Print it on posters and clinic flyers

Outcomes reporting

Outcomes reported by a caregiver, not just the patient

Many rare disease populations include young children or patients who cannot reliably self-report. Capture's ePRO supports observer-reported outcomes (ObsRO) completed by a caregiver, alongside patient-reported (PRO), clinician-reported (ClinRO) and site-run performance outcomes (PerfO), all on the same platform and audit trail as the rest of the study.

  • ObsRO diaries for a parent or caregiver to complete on the participant's behalf.
  • The same no-app-install, link-based access as any other ePRO diary.
  • One audit trail across caregiver-reported, clinician-reported and EDC data.
See ePRO software

Evening diary

Question 3 of 8

How would you rate your fatigue today?

0 = no fatigue, 10 = worst imaginable

012345678910
Add a photo (optional)
BackNext
● Answers saved as they go

Natural history and registries

Where registry and real-world data support already fits

A natural history or registry study before an interventional trial

The same EDC and eCRF builder power Capture's existing registry and real-world evidence (RWE) study pages; a rare disease natural history study runs on the same base.

Long, sparse follow-up schedules

Visit schedules with wide or irregular windows are set up the same way as any other protocol; Capture does not assume a dense, fixed visit calendar.

Small-N statistics support

Capture is a data capture and export platform. Statistical design and analysis, including small-N and Bayesian approaches, are done by your own biostatistics team; see our Bayesian design guide for the current regulatory picture.

Before you switch

What rare disease teams ask before committing

Cost

Free sandbox with no minimum patient or site count, so a small program is not priced like a large one.

Compliance

Field-level audit trail and OTP-verified e-signatures on every record, in every hosting region.

Setup time

AI drafts forms and visit schedules from a protocol or description, useful when a small team wears every hat.

Migration

Bring an existing registry or natural history dataset across during analysis; direct import depends on the source format.

Support

Email support, typically under 24 hours, plus documentation on Enterprise.

Build your rare disease study in a free sandbox

No credit card, no minimum patient count.

Build your rare disease study free

FAQ

Questions teams ask before they switch

Something not covered here? Ask us directly.

Does Capture have rare-disease-specific features?

There is no dedicated "rare disease" module. What it has is the same EDC, ePRO and registry support described on this page, which fits a small, scattered, caregiver-reported population well.

Can Capture support a natural history study before an interventional trial starts?

Yes, on the same EDC and eCRF builder as Capture's existing registry and real-world evidence study pages.

Does ePRO support a caregiver completing a diary for a child or non-verbal patient?

Yes. Observer-reported outcomes (ObsRO) let a caregiver complete a diary on the participant's behalf, alongside patient-, clinician- and performance-reported outcome types.

Is there a minimum number of patients or sites to use Capture?

No. The free sandbox has no minimum, and the same platform works for a 3-site program or a 300-site one.

Does Capture run the statistical analysis for a small-N or Bayesian design?

No. Capture captures and exports the data. Statistical design and analysis are your biostatistics team's work, in their own statistical software.

Can we run sites in more than one country?

Yes. EU (Frankfurt) and US (N. Virginia) hosting regions, plus by-site filtering, support multi-country programs.

Can we test this before committing to a rare disease program?

Yes. The free sandbox includes every feature with sample data, no credit card required.

Build your rare disease study in a free sandbox

No credit card, no minimum patient count.

Build your rare disease study free