Get the study moving.
Turn what you have into a build your team can review and put to work.
From intent to live studyAI-native clinical research.
Build the study
you mean.
Bring a protocol document, a digital protocol, existing forms or an idea. Build by hand, prompt an agent, or combine both. Take the study from intent to reviewed design—and on to your EDC.
One shared study model. From intent to analysis.
Try the connectionProtocol documentAssessments · §4.2
Collect vital signs, laboratory results, adverse events and outcomes throughout treatment and at follow-up.
Agent proposalProposed · review required
Forms · visits · collection rules
A connected collection plan
AssessmentTreatmentFollow-up
Vital signs
Laboratory results
Adverse events
Outcomes
Source → proposed design
Protocol §4.2 connects the assessments to their collection schedule. The agent proposes the linked structure; your team reviews the definitions and resolves missing detail.
You decide what becomes part of the study.
Source.Structure.Decision.Connected.
Illustrative interaction · synthetic study
The destination is a live study.
The way there is yours.
The cost of starting over
The expensive part
is doing it again.
A protocol becomes a specification, a database, then an analysis. Each handoff can mean another round of interpretation, rebuilding and review. An amendment starts the cycle again.
Study setup · 2017 survey68.3 days
Average reported time to build and release a study database.
Tufts CSDD · 257 companies ↗Change is routine · 2024 study76%
Protocols in the study had at least one amendment.
Tufts CSDD · 950 protocols ↗The cost of change · 2016 study$535k
Median direct cost to implement a substantial Phase III amendment.
Tufts CSDD · historical USD ↗What these benchmarks measure
These are separate published industry studies, not Clinstead results. The database benchmark is a self-reported 2017 survey, published in 2018. The 2024 amendment study covered 16 companies and protocols reaching database lock or primary completion in 2016–2021; 77% of amendments were considered unavoidable. The 2016 cost estimates used 52 protocols and cover amendment implementation, not just database work. These figures are not estimates of recoverable time or cost.
What changes for the research
Time is only the beginning.
Know what needs you.
See the source, the proposed change and the unresolved decision together.
Work you can inspectAsk more of the data.
clinstead resolve will carry research questions through investigation, transformation and checked outputs.
clinstead resolve · in developmentLess rework.
More research.
What could your team do with the time back?
Illustrative scenario · per studyPotential time saved
hours
back.
back.
That’s 5 days of someone’s expertise.
Before200 hours
Your scenario160 hours
PreparationReviewTime back
Equivalent team capacity£3,000
per hour
Capacity to redeploy. Not a cash saving.
Make it your scenario.
Requirements, field drafting and consistency checks.
The share of that work you aim to save.
Preserved in full.
40 hours potentially saved per study. 5 eight-hour person-days. £3,000 in equivalent team capacity. Before 200 hours; scenario 160 hours. Review remains 40 hours.
More time for the questions that move research forward.
Explore the opportunity in your workflowBuild at the speed
of iteration.
First build. Inherited forms. A protocol that keeps evolving. Direct agents across the study, inspect the connected work and make the decisions that move it forward.
Explore the study from every angleThe assignment
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.”
Collection planSelect an assessment
| Assessment | Screen | Baseline | Week 4 | Week 8 | Week 12 | Follow-up |
|---|---|---|---|---|---|---|
| — | — | — | — | — | ||
| — | — | — | — | |||
| — | — | |||||
| — | — | |||||
| — | ||||||
| — | — | — |
Swipe to explore the full schedule →
Scheduled◇ Conditional / cohort-specific
Data manager
Laboratory results
Connect the collection event, result structure and visit. Keep each relationship inspectable.
Scheduled collection
Screen · Baseline · Week 4 · Week 8 · Week 12 · Follow-up
§6.2 · Laboratory assessments
“Collect haematology and chemistry at scheduled visits. Record collection date, units and laboratory reference limits.”
Source → proposal → review
One Clinstead. One continuous study.From first intent
From first intent
to final analysis.
Carry the study's meaning forward. Its source, structure and decisions should keep working for you long after the database goes live.
clinstead designer today · clinstead resolve in developmentclinstead designer
Intent → live study
Bring your starting point. Prompt, build or combine both. Shape a study ready for collection.
The connection that matters
Shared study model
SourceStructureDecisionsVersions
Study meaning, carried through the lifecycle.
clinstead resolve
Collected data → analysis
Natural language or a direct UI. Study-aware intelligence, with the SAP guiding the path to SDTM and ADaM outputs.
In developmentInside the agentic engine
Interactive walkthrough · example dataInspect how clinstead designer turns an ask into accountable work.
01 / 04
The request arrives with a study around it.
The engine works with the current study, your selected context and active reference documents.
The same request, throughout
“Extend safety follow-up to Week 12 in the active-treatment arm. Repeat vital signs, labs and adverse-event review. Keep ongoing events under follow-up.”
Context available to the planner
Current studyExisting arms, safety forms and treatment schedule
Your selectionActive-treatment arm / safety follow-up
Protocol · assessment schedule
Add Week 12 safety follow-up for the active-treatment arm, with vital signs, laboratory assessments and review of ongoing adverse events.Example source passage
Confidence you can inspect
Put the build
to the test.
A convincing build should stand up to scrutiny. Compare fields with their source, expose what is missing and review each addition. Challenge the build, or follow an amendment into the details it changes.
Evidence behind the result
01
Make a mistake. See it caught.
A separate source comparison checks what the build preserved.
Demographics / Sex
C28421Source propertyRequired
isRequired: trueGenerated fieldRequired
is_required: true3 of 3 example checks match
Requiredness, generated type and coded answers agree with the source.
Male
C20197Female C1657602
Know what still needs a decision.
A named activity does not always define a collection field.
Definition needed
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.
Recorded results from the reference study. The interactive checks use local examples; template content is illustrative.
Amendment, in contextBaseline preserved
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.
Follow the impactProposed revision
Schedule & timing
- §6.1
Add Week 12 and link its safety assessments.
- §6.2
Revise the Week 4 and Week 8 timing windows.
Before acceptance
Confirm the reference event and when the amendment takes effect.
The consequences continue into the data.
With clinstead resolve, follow the changed study definitions into affected mappings and derivations, then review the implications against the SAP.
clinstead resolve · planned workflowOne study model connects the change.Synthetic scenario · interactive impact illustration
See the source. Record the decision. Know which version you are delivering. Practical controls for work that has to withstand review.
Trust, provenance & evaluationBuilt for the way forward
Your study moves.
Your systems stay.
Keep the EDC that works for you. Shape the study in Clinstead, carry the reviewed design into collection, and build on that context as the data arrives. One study across the tools you use.
From reviewed design to collectionIllustrative study delivery
Study design · revision 02A study ready to move.
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 travelsStudy structureForms, fields & visit assignments
Design reviewRecorded decisions
Output identityIdentifiable design & delivery package
Collection environmentYour chosen EDC
Before activationDestination import & acceptance checks
Under 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.
Ask more
of your data.
Next from Clinstead: agents that take your question through investigation, transformation and checked results. Work in natural language or the UI, with the protocol, shared study model and SAP in view. Generate the SDTM and ADaM datasets the analysis needs.
Explore clinstead resolve · in developmentDirect the work. Follow the evidence.In development · planned workflows
“The interim cut is approaching. Reconcile EDC, lab and dosing data. Tell me what threatens the analysis—and prepare the work to resolve it.”
Working with
Protocol & study model / EDC, lab & dosing data / SAP
Inside the agent’s work
Use the study schedule, cohort rules and analysis requirements to establish what should exist for this cut.
Investigation briefIllustrative result
Three signals. Three different next moves.
- Transfer gap
- The lab has the scheduled result. Reconcile the transfer before asking the site to recollect.
- Unit conflict
- The result and reference interval use different units. Hold the interpretation for a reviewed conversion.
- Timing conflict
- A post-dose sample precedes the recorded dose. Prepare an evidence-linked query; preserve both source records.
Follow the reasoning
The same missing-value report can hide very different causes. Study expectations, source records and timing relationships let the agent propose the right action for each finding. An uncertain match stays unresolved.
Review the findings and proposed actions before release.
From a wall of discrepancies to work that matters.
The same Clinstead study model. Design intent, source evidence and reviewed decisions travel into the data work.
Your next study starts here.
Bring the study. Let’s move it forward.
See your workflow with ClinsteadStart with the work you have. Show us where you want to go.