Regulatory alignment
Caytra is designed to support sponsor and site compliance with ICH E6(R2), FDA inspection expectations, and sponsor QA standards by embedding protocol requirements directly into operational workflows.
Caytra does not replace investigator oversight, monitoring, or quality systems. It enforces execution constraints at the site level to reduce preventable deviations before they occur.
Protocol interpretation and control
Protocol requirements are operationalized into enforceable logic governing timing, sequencing, and evidence capture. Execution paths that violate protocol-defined constraints are blocked until required conditions are met.
This approach shifts compliance from post-hoc detection to prospective prevention at the point of execution.
Key controls include:
- Visit window enforcement
- Infusion and PK timing constraints
- Required evidence gating prior to progression
- Role-based execution permissions
Execution evidence and traceability
All enforcement actions, overrides, and execution events are logged with time stamps and contextual metadata. Documentation is structured to support sponsor audits and regulatory inspections without retrospective reconstruction.
Evidence supports:
- What occurred
- When it occurred
- Why it was allowed or blocked
- What protocol logic applied at the time
Deviation prevention and visibility
Caytra is designed to reduce common oncology deviations related to timing, sequencing, and missed requirements. When execution falls outside protocol-defined constraints, progression is blocked and flagged in real time.
Deviation risk is surfaced immediately to site leadership and sponsors rather than identified weeks later during monitoring visits. Deviations are prevented at execution, not discovered in monitoring.
Data handling and privacy
Protocol logic is processed without persistent storage. Sponsor intellectual property and protocol content do not reside in Caytra systems beyond transient execution context.
Caytra is not a data warehouse, EDC, or eTMF. It operates as an execution control layer.
Scope and responsibility
Caytra supports compliant execution but does not assume investigator responsibilities, monitoring functions, medical decision-making, or CRO obligations.
Ultimate responsibility for protocol compliance remains with the investigator, sponsor, and designated parties per regulatory requirements.