Submission-ready evidence
- Traceable metadata from study design to submission
- Audit trails and governance built in
- Standardized outputs for SEND, IND, and IMPD
Regulatory & Compliance
Built for compliance, not retrofitted for it.
Lower review friction
- Fewer translation steps across teams and CROs
- Reuse-ready evidence reduces duplicate submissions
- Predictable packages aligned with expectations
Core message
Built for compliance, not retrofitted for it.
Compliance as an output, not a constraint.
Standards alignment
Designed to align with compliance expectations and evidence workflows.
FDA
Submission-ready evidence packages with traceable metadata.
EMA
Structured metadata to support consistent submissions.
ICH S11
Aligned data governance, auditability, and nonclinical safety expectations.
Submission outputs
SEND
SEND-ready metadata built from standardized, ontology-driven structures.
IND / IMPD
Traceable evidence packages that reduce review friction.
Audit trails
Provenance and change history to support compliance reviews.
Data governance
Access controls, retention, and validation for audit-grade stewardship.
Emerging evidence pathways
NAMs readiness
Structured metadata supports new approach methodologies without losing audit traceability.
VCG readiness
Metadata reuse and comparability enable virtual control group workflows.