Build the whole study in one place, not just the forms
Visits, windows, forms, sites and launch checks live in one builder. Start from your protocol, a plain-language description or a ready-made Phase 1 schedule, and your own team stays in control of every change.
- Protocol, description or template start
- Schedule and forms together
- Launch checks built in
Free sandbox · No credit card · 21 CFR Part 11 compliant
3
ways to start: protocol, description or template
6
ways to anchor a visit date
4
visit locations, from on-site to home
1
readiness list before you launch
How it works
From empty study to first participant
- 1
Start the study
Upload the protocol, describe the study, or begin with the standard Phase 1 schedule.
- 2
Shape the schedule
Set visits, windows and anchors, then tick which forms happen at each visit.
- 3
Build the forms
Draft CRFs with AI or templates, then add edit checks and calculated fields.
- 4
Activate sites and launch
Each site passes a short activation checklist before any participant is added.
Start
Three ways to start, none of them a blank page
Most study builders open on an empty grid. Capture gives you a working draft from whatever you have on hand, and everything it creates stays editable.
- Upload a protocol (PDF, DOCX or DOC) and get draft visits, windows and forms.
- Describe the study in plain language and let the AI Study Generator build the structure.
- Or start from a standard Phase 1 schedule: screening, admission, dosing days, follow-ups and end of study.
Upload protocol
PDF, DOCX or DOC
Describe it
Plain-language summary
Phase 1 template
8 visits, ready to edit
- D-28Screening
- D-1Admission
- D1Dosing
- D3Discharge
- D8Follow-up
- D15Follow-up
- D29End of study
Visits
Visits that follow your protocol logic
Each visit carries its own timing rules. Anchor it to the right date, set its window and choose how strictly the window is enforced, so the schedule each participant sees is correct from day one.
- Anchor to screening, a milestone such as randomization, an earlier visit, a fixed study day or a date entered on a form.
- Offsets in days, weeks or months, with a window before and after.
- Epochs for screening, treatment, follow-up, unscheduled and early termination visits.
- On-site, remote, home or hybrid visit locations.
Anchor
- Screening date
- Milestone (e.g. Randomization)
- An earlier visit's date
- Fixed study day
- A form field date
Offset
Window
Epoch
TreatmentVisit location
Forms
Forms built in the same place as the schedule
Attach a form to a visit with one click in the schedule matrix. Build it with AI, copy a template, or design it yourself, with edit checks and calculated fields included.
- Template library with demographics, vital signs, ECG, labs, AEs and more.
- Edit checks that raise auto-queries at the point of entry.
- Draft and approved states, so only approved forms go live.
Demographics
SDTM DM
Vital signs
SDTM VS
ECG
SDTM EG
Physical examination
SDTM PE
Laboratory
SDTM LB
Medical history
SDTM MH
Adverse events
SDTM AE
Concomitant medications
SDTM CM
Start with a real schedule in minutes
Create a free sandbox study from your protocol or the Phase 1 template and click through it with sample data.
Launch
A study that cannot go live half-built
Capture checks readiness before anything reaches a participant. A study needs at least one activated site to launch, and each site is activated only when its checklist is complete.
- Site activation checklist: ethics approval date, contract, site initiation visit date and delegation log.
- Until a site is activated, nobody can add, screen or randomize participants there.
- A pre-launch readiness list names any form in the schedule that is not yet approved.
- Every activation is recorded in the audit trail with who and when.
- IRB/EC approved12-Aug-2026
- Contract executedConfirmed
- Site initiated / SIV completed02-Sep-2026
- Delegation log completeConfirmed
Pre-launch readiness
1 site activated
1 form not yet approved
The difference
A traditional study build vs a study built in Capture
What is clinical trial study builder software?
It is software for setting up a study before data collection starts: the visit schedule, the forms collected at each visit, the sites and the rules that govern them. Capture brings all of these into one builder so the study team can set it up without a programmer.
Do I need a protocol to start?
No. You can upload a protocol, describe the study in plain language, or start from a standard Phase 1 schedule and edit it. All three give you an editable draft.
How are visit dates calculated?
Each visit is anchored to a date: screening, a milestone such as randomization, an earlier visit, a fixed study day or a date recorded on a form. You then set the offset and the window around it.
Can visits happen outside the clinic?
Yes. Each visit can be marked on-site, remote, home or hybrid, so decentralized and hybrid designs are part of the same schedule.
What stops a study from launching too early?
A study needs at least one activated site to launch. Sites are activated only after their checklist is complete, and until then no participant can be added, screened or randomized at that site.
Can I change the study after it goes live?
Yes. Changes are made deliberately and recorded in the audit trail, and approved forms stay locked for live use so data collection is never changed silently.
Can I reuse a study I already built?
Yes. A study configuration can be exported and imported into a new study, which copies over its forms and visit schedule as a starting point.
Can I try it for free?
Yes. The free sandbox includes nearly every feature and sample data, with no credit card needed.
Keep exploring
Related pages
Protocol-to-study setup
Turn a protocol PDF into a draft study.
Study design tools
Anchors, windows, arms and epochs.
CRF builder
AI drafting, edit checks, calculations.
Clinical trial workflow software
Run the study once it is live.
Software to build CRFs
From protocol to approved casebook.
Platform overview
Everything Capture does in one place.
Build your study today
Free sandbox with nearly every feature. No credit card, no sales call.