A unified operating system for clinical research.
Clinstead centralises study definition, execution and control into a single cohesive architecture. A study is not just a protocol, not just an EDC, not just a CTMS and not just a participant app. It is a living operational system — and each product surface works from the same canonical study model.
The architecture, in three ideas.
Single source of truth
Every form, visit schedule and logic check exists as a single entity in the canonical model. Update it once and it propagates across all connected applications.
Evidence-ready design
Built for regulated research workflows. Every data point is versioned, attributable and maintains full lineage from capture to export.
Live protocol amendments
Execute mid-study changes safely. Handle database migrations, site-specific versioning and transition rules through structured amendment diffs.
The continuity layer across every workflow.
Clinstead’s core technical advantage is continuity. The study is represented as a structured model of the protocol, arms, events, visits, instruments, fields, logic, validations, schedules, consent rules, participant tasks, amendments and operational workflows. That model can be reviewed, validated, compiled, executed, amended and analysed.
One study model powers the build, the EDC, the CTMS, the participant journey and the operational view.
- The build does not drift from the protocol
- Participant tasks match the approved study schedule
- Monitoring understands the forms, visits and data structure
- Data review understands the logic and validation rules
- Safety and consent stay tied to participant state
- Reports remain tied to study version
- Amendments can be compared before deployment
- Agents operate from structured study context, not guesswork
A study that stays connected as it runs.
Every change in study design propagates into execution. Every runtime signal informs oversight. Every participant interaction lands as structured study context. Every amendment can be compared before it is deployed.
Define
SteadFlow
Author the study from protocol, CRFs and schedules. Forms, fields, logic, repeats and mappings become a structured canonical model.
Capture
SteadEDC
Execute visits, forms, validations, queries and data capture from the approved model.
Operate
SteadOps
Control monitoring, site risk, data review, safety, documentation, integrations, analytics and lock readiness.
Reach
SteadReach
Deliver participant tasks, eCOA, ePRO, diaries, reminders and support from the same study model.
The study lifecycle, connected by design.
Clinstead brings build, capture, operations, participants, analytics and agents into one operating environment. Each capability is useful on its own. The real power comes from all of them working from the same canonical study model.
Canonical study model
One structured model for protocol, visits, forms, fields, logic, participants, amendments and operational state.
Deterministic build and compile
SteadFlow turns study documents into validated build artifacts, starting with REDCap-ready outputs.
Clinical data capture
SteadEDC runs forms, visits, validations, queries and audit trails from the approved model.
CTMS and operational control
SteadOps manages monitoring, site oversight, data review, safety, documentation and lock readiness.
Participant execution
SteadReach delivers BYOD onboarding, eCOA, ePRO, diaries, reminders, rescue flows and support.
Amendment impact
Compare proposed changes against the live study model before deployment.
Query and data intelligence
Surface discrepancies, stale queries, recurring patterns and lock blockers.
Bounded AI agents
Agents draft, recommend and escalate using structured study context, with human approval for high-risk actions.
The operating discipline regulated research expects.
- Audit trails
- Controlled deployment
- Role-aware access
- Versioned study definitions
- Reason-for-change workflows
- Evidence-ready operations
- Human-approved agents
Clinstead is not claiming certifications it has not earned. The platform is being built with the operating discipline regulated research expects. Read the governance overview →
Explore the four product surfaces.
See it on your protocol.
Bring your protocol. We will show how Clinstead turns it into a structured study model and connects definition, data capture, operations and participant workflows.