Oncology trial execution platform
Enforced protocol execution for timing-critical oncology workflows.
Protocol Audit Console
Intelligent verification of protocol adherence with citation-level traceability aligned to ICH E6(R2). The Protocol Audit Console analyzes protocol documents and execution records to identify deviations before they become findings. Every verification action is traceable to specific protocol citations, creating inspection-ready documentation by design.
How this supports inspectionsEvidence Gating
Execution blocked until protocol-required evidence is secured. Using a mechanical aperture model, Evidence Gating creates binary state validation: open (action required) or closed (evidence secured). This prevents progression through protocol-critical steps until all required documentation, approvals, and verifications are complete—eliminating a major class of protocol deviations at the point of execution.
How deviations are preventedPrecision Timing
Sub-minute enforcement of protocol-defined timing windows for oncology infusions and PK collections. Timing deviations are among the most common FDA findings in oncology trials. Precision Timing enforces protocol-specified windows for infusion start times, PK blood draws, and lab processing—preventing timing violations before they occur and maintaining data integrity for pharmacokinetic analyses.
Timing compliance controlsTraining Intelligence
Risk-targeted training for high-impact execution scenarios. Unlike generic LMS systems, Training Intelligence identifies protocol-specific risk points and delivers mastery-based training for clinical operations teams. Training is supportive of compliant execution but never a substitute for system enforcement—FDA expects training but does not trust it alone.
Role of training vs enforcementSponsor Transparency
Structured, immutable execution records for sponsor review. Every enforcement action, override, and execution event is logged with timestamps and contextual metadata. Immutable audit trails with guilloche-patterned security markers provide financial-grade data integrity for regulatory inspections. Documentation is structured to support sponsor audits without retrospective reconstruction.
Audit visibility explainedSite Clarity
Low-friction interface designed for clinical execution environments. Dark-mode native interface optimized for low-light clinical settings with bioluminescent cyan accents for critical alerts. Site Clarity reduces cognitive load during high-pressure execution scenarios, allowing CRCs to focus on patient care while the system enforces protocol compliance.
Caytra minimizes additional site burden by enforcing requirements only at protocol-critical execution points.