Operational control, not operational debt.
SteadOps brings clinical study operations into one connected system. Monitoring, site oversight, data review, safety, documentation, integrations, analytics and lock readiness — over the live study model.
The connective tissue between capture and milestones.
SteadOps ensures that monitoring, safety and documentation are always in sync with the live study state — instead of running through spreadsheets, trackers and disconnected reports.
Monitoring & SDV
Centralised monitoring queues with risk-based alerts. SDV workflows linked directly to capture data.
Safety operations
Real-time tracking of adverse events and safety escalations, with operational tracking and follow-up.
Lock readiness
Live visibility into data completeness and query status. Dry-lock runs identify blockers before the deadline.
Study documentation
Integrated eTMF artefacts and release records, generated from operational workflows alongside the live study.
The operations agent.
The Operations Agent acts as a continuous clinical research partner, observing the health of the entire study infrastructure.
Observe
The Operations Agent observes operational KPIs: site recruitment rates, data entry lag, query ageing and safety signal density.
Recommend
When performance drops, the agent recommends specific interventions: site retraining, resource reallocation or logic refinement.
Escalate
If risks threaten a database lock or interim analysis, the agent escalates to the Study Director with a full impact assessment.
What SteadOps is. And what it is not.
- A centralised study oversight environment
- A control layer for monitoring and safety
- A real-time database lock readiness tool
- A connective layer for disparate clinical systems
- A general-purpose ERP or project manager
- A marketing or social proof platform
- A simple spreadsheet replacement
- A document management system
Close the loop on study operations.
SteadOps integrates with the entire Clinstead ecosystem to provide a single source of truth for study execution.