Clinical research,
compiled into execution.
Clinstead turns protocols, CRFs, schedules and study requirements into structured, validated, operational study systems — connecting study definition, data capture, live operations and participant engagement through one canonical model.
Built by a team with research backgrounds from
Direct experience across academic clinical research, oncology trials and large-scale platform engineering.
Clinical studies are rebuilt at every handoff.
A study starts as a protocol, CRFs, schedules of assessments, eligibility criteria, consent requirements, participant tasks and operational rules. Then the same study is manually rebuilt into EDC forms, surveys, monitoring plans, spreadsheets, trackers, queries, reports, amendment logs and documentation. Every handoff introduces interpretation, delay, rework and risk.
The approved protocol is manually retyped into a study database, with forms, fields, logic and validation rules reconstructed from scratch.
Paper or document CRFs are rebuilt by hand inside the EDC, losing their connection to the source protocol and amendment history.
Visit windows, procedures and dependencies are rebuilt separately for the database, the monitoring plan and the participant workflow.
eCOA, ePRO, diaries and reminders are wired through disconnected survey tools that do not understand visit state or eligibility.
Site risk, SDV, deviations and follow-up actions run through spreadsheets and trackers that sit outside the live study system.
Operational visibility depends on point-in-time exports, offline analysis and meetings, not the live state of the study.
A single protocol change ripples through forms, visits, participant materials, monitoring plans, reports, exports and documentation.
SteadFlow defines the study. SteadEDC captures and executes it. SteadOps controls live operations. SteadReach delivers it to participants. Clinstead connects all four through one canonical study model.
Outcome: fewer manual rebuilds, safer amendments, cleaner execution, better oversight, stronger participant workflows and less fragmentation.
One operating system. Four connected product surfaces.
Because all four surfaces work from the same canonical model, the study does not need to be rebuilt every time it moves from protocol to database, operations, monitoring, participant engagement, reporting or lock.
AI that works inside the study. Not around it.
SteadOS agents operate over structured study context — protocol, forms, logic, visits, queries, participants, amendments, audit trail. That makes them useful, bounded and inspectable. High-risk actions require human approval. Every recommendation is logged.
Monitoring
Ranks sites by risk and prepares review queues.
Data management
Finds anomalies and prioritises cleaning work.
Queries
De-duplicates candidates and escalates stale items.
Amendment impact
Compares proposed vs active and shows what changes.
The model gives agents context. The rules give them boundaries. The audit trail gives them accountability. Humans keep control.
See all 8 agentsBuilt for regulated research workflows.
Clinstead is designed around traceability, controlled change, role-aware access and audit-ready operations. From study definition to runtime execution, important actions are intended to be versioned, reviewable and attributable.
Versioned study definitions
Studies live as structured, snapshotable definitions. Amendments compare proposed against active before deployment.
Controlled deployment
Deterministic compile paths and release records. Deployment history and amendment traceability are part of the operating model.
Reason-for-change capture
Designed for Part 11-style traceability and reason-for-change workflows. Evidence-ready operational records throughout.
Human-approved automation
Role-aware access with clear permission boundaries. High-risk agent actions require human approval.
Stop rebuilding the same study across disconnected systems.
Bring your protocol. We will show how Clinstead turns it into a structured study model, validates the build path and connects study definition to data capture, operations, participant workflows and oversight.
Start with SteadFlow. Expand into SteadEDC, SteadOps and SteadReach as your study operations mature.