Study design & deliveryYour intent.
A study taking shape.
Bring a protocol document, a digital protocol, existing forms or an idea. Direct AI agents, build in the UI, or combine both. Shape a study your team can review, refine and take live in your EDC.
See your workflow with ClinsteadSee what the decision
rests on.
From a protocol passage to a proposed field, inspect the connection. Refine the proposal, make a manual edit and test the form. Your team decides what becomes part of the study.
Meridian · study protocol
Vital signs will be assessed at baseline and Week 4. If fever is reported, record body temperature in °C. Record each assessment in the corresponding visit form.
Add a temperature field. Show it when fever is reported.
The passage specifies the measurement, unit and condition. The visit schedule supplies where it is collected.
Vital signs
Baseline / Week 4Accept the proposal to see its behaviour here.
The collection plan
Review the proposed visit assignments before accepting.
Behind the request: an agent working with the current study, selected context and source material. Typed operations, dependency checks and explicit review turn an instruction into a controlled change.
Inside the Clinstead engineOne study.
Every expert’s perspective.
A protocol document, structured intent or a library of inherited forms. See agents connect the collection plan, field definitions and review decisions across a whole study.
A whole study. All its moving parts.
“Build the collection plan across screening, treatment and follow-up. Connect the safety forms, repeat assessments and rules to the protocol. Flag what needs a decision.”
| Assessment | Screen | Baseline | Week 4 | Week 8 | Week 12 | Follow-up |
|---|---|---|---|---|---|---|
| — | — | — | — | — | ||
| — | — | — | — | |||
| — | — | |||||
| — | — | |||||
| — | ||||||
| — | — | — |
Swipe to explore the full schedule →
Laboratory results
Connect the collection event, result structure and visit. Keep each relationship inspectable.
Screen · Baseline · Week 4 · Week 8 · Week 12 · Follow-up
“Collect haematology and chemistry at scheduled visits. Record collection date, units and laboratory reference limits.”
Source → proposal → review
Inspect a recorded USDM workflow
A closer look at a supported USDM 4.0 build: source relationships, field definitions and independent checks.
| Collection form | Screen One | Screen Two | Dose | Week 2 | Week 4 | Week 6 | Week 8 | Week NPI |
|---|---|---|---|---|---|---|---|---|
| — | — | — | — | — | — | — | ||
| — | ||||||||
| — | — | — |
16 instances have source-defined arm scope. 8 use a provisional all-arm scope that remains flagged for review. Filters show the recorded mapping, including those provisional assignments.
Explore how a digital protocol becomes an editable design, with its relationships and evidence intact.
Understand the standardsFind the issue.
Make the call.
Check generated fields against their source. Distinguish an acquisition gap from a workflow decision. Bring a reviewed template to complete missing detail, with the original evidence still in view.
Make a mistake. See it caught.
A separate source comparison checks what the build preserved.
C28421isRequired: trueis_required: trueRequiredness, generated type and coded answers agree with the source.
C20197Female C16576Know what still needs a decision.
A named activity does not always define a collection field.
Physical examination
The source names the concept. Its property list is empty: no acquisition fields, types, choices or required rules.
BiomedicalConcept_34properties: []Inspect the recorded quality results
The reference study recorded 310 passed source checks and 278 passed output checks. A further 23 activities remained open for acquisition or workflow review. These results cover the recorded checks, not every aspect of study readiness.
Change the study.
Keep the context.
Compare the amendment, inspect the affected output and preserve the baseline. A change is easier to review when its consequences are explicit.
A change in the protocol.
A chain of consequences.
Visits. Forms. Rules. Cohorts. Follow the amendment through the work it touches, before accepting the new design.
- §6.1
Add Week 12 and link its safety assessments.
- §6.2
Revise the Week 4 and Week 8 timing windows.
Confirm the reference event and when the amendment takes effect.
With clinstead resolve, follow the changed study definitions into affected mappings and derivations, then review the implications against the SAP.
clinstead resolve · planned workflowInspect the recorded timing comparison
The broader scenario above is illustrative. This reference shows a focused source-to-output amendment comparison.
A wider window.
A precise account of the change.
Compare the proposed source with its baseline before changing the study.
Timing_4 · P3D / P3DTiming_4 · P5D / P5DFollow the source change into the generated configuration.
Inspect the amendment reference
$.study.versions[-1].studyDesigns[0].scheduleTimelines[0].timings[3]The ±3 to ±5 day amendment is a synthetic change to the recorded reference study. This read-only illustration compares generated configurations; it does not apply an amendment to a live study.
Source reconciliation, design checks and output checks answer different questions. Make each visible—and keep expert review where it belongs.
Explore the control frameworkGood design
should travel.
The study should move beyond its authoring environment. Carry reviewed structure into your chosen collection system, with a clear design revision, a defined delivery profile and an acceptance path.
A study ready to move.
With the work behind it.
Carry the reviewed structure forward, with its design decisions close at hand. Your team can identify the design being delivered, inspect the package and agree acceptance in the destination.
Explore how your study travelsUnder the surface: exchange and acceptance
CDISC ODM XML is a demonstrated exchange route. A delivery profile matches the destination’s supported study constructs and import process. Format checks, study review and destination acceptance are distinct steps; the package remains tied to the design snapshot that produced it.
The study model continues beyond the handoff. clinstead resolve is being built to connect collected data, the SAP and analysis outputs to the same intent, design and decisions.
Carry the study into analysisLet’s put your study to work.
See your workflow with ClinsteadStart with the work you have. Show us where you want to go.