New · V5Now in early access

The visual builder clinical data managers actually wanted.

Drag a field. Branch a version. Let AI scaffold the rest. Datacapt V5 turns weeks of study build into an afternoon — without leaving the canvas.

CDISC ODM-native21 CFR Part 11HDS · ISO 27001 · GDPRIn-place migration from V4
Trusted by sponsors and CROs running clinical trials in 30+ countries
NORTHWAY BIOAldermarsh CROTESSERAhalcyon/clinMERIDIANQuill & Trace
The problem

Clinical data managers are running modern trials on legacy software.

The category is decades old and barely moves. Most platforms were built before SDTM was finalized — and it shows in every protocol, every amendment, every day.

01 · Outdated

Stuck in 2005.

Most EDCs are wrapper UIs on databases designed two decades ago. Modern auth, real-time previews, and useful field types are bolted on after the fact — never native.

18+ yrs average core platform age
02 · Slow

Twelve weeks before first patient.

Study build is a multi-vendor relay — protocol, spec, builder, tester, UAT, migration window. Most of it is waiting, not building. Teams ship roughly one form per day.

12–16 wks median study build, V4 era
03 · Brittle

Every amendment is a re-implementation.

Branching, diffs, and revision history don't exist in legacy EDCs. Each protocol change means a copied study, a new validation cycle, and a freeze on live data.

~12 wks median amendment cycle
What's new in V5

Study build, finally rebuilt.

Everything that used to live across separate tools and screens now sits on one canvas — updating in real time, and shipping as a single versioned amendment.

01 · New three-panel builder

Structure, canvas, inspector. One screen, no modals.

Visits and forms on the left, the form canvas in the middle, the inspector on the right. Click anything; everything else updates. Drag a field in; the data model, the SDTM mapping, and the live preview all reflect it before your finger leaves the trackpad.

  • Full drag and drop Drag fields, reorder sections, move forms between visits.
  • Real-time preview The site-side eCRF renders as you build, on every keystroke.
  • Keyboard-first Every action has a shortcut. ⌘K for everything else.
Builder · adverse events3-panel layout

Visits / Forms on the left · Canvas in the middle · Inspector on the right.

AI scaffolded · review every line9 fields · 4 checks

“Add a serious adverse event form per CTCAE v5. Repeat per visit. Include MedDRA-coded preferred term and edit check for SAE causality.”

  • AETERM · char · MedDRA PT
  • AESTDTC · iso8601
  • AESEV · CTCAE codelist
  • AESER · AEREL · AEACN · + 3 more
02 · AI builder

Describe the protocol. Review the form.

Datacapt AI reads your protocol section and scaffolds forms, fields, and edit checks against CDASH and your standard library. Every line is reviewable, editable, and logged in the audit trail. AI never alters subject data — only structure during build.

  • Suggests, never decides You approve every field, codelist, and check before it lands in the build.
  • Therapeutic context aware Trained on your standard library and CDISC dictionaries — not on PHI.
  • Validated infrastructure Operates inside the validated Datacapt environment, fully auditable.
03 · Versioning & revisions

Every revision tracked. Every amendment is a diff.

Branch the study like code. Review changes line by line. Promote to production with an audit trail Part 11 will accept on the first read. Subjects already enrolled stay on the version they consented to — automatically. No copied study, no re-validation of the runtime.

  • Per-revision history Down to the keystroke. ⌘Z works across days, not sessions.
  • Amendment as a branch Edit safely, diff against production, promote when ready.
  • Subject-version pinning Existing subjects stay on v0.6; new enrolments get v0.7 from next visit.
Versions · ONCO-204Amendment 2
  • v0.7 Draft · amendment-2 · 3 changes · Maya, 14:02 today
  • v0.6 Production · amendment-1 · 42 subjects · promoted Mar 12
  • v0.5 Archived · initial build · promoted Jan 04
Schedule of assessmentsVisit windows · ±days

Visits across the top (SCR · D1 · W2 · W4 · W8 · W12 · W24 · EOS). Forms down the side. Date windows ±3 days at the visit level.

04 · Visit timeline & windows

The schedule of assessments, on a grid you edit in place.

Visits across the top. Forms down the side. Click a cell to assign. Drag a window to set ±days. The protocol's table compiles directly into the database — no second source of truth living in someone's spreadsheet.

  • Date windows on every visit ±days at the visit level, overridable per form.
  • Repeatable visits Treatment cycles, follow-ups, unscheduled — each with its own version.
  • Drag to reschedule Move a visit, rebuild the windows, regenerate the calendar.