Faster IND / IMPD preparation
Regulator-ready evidence packages reduce review cycles and late-stage fixes.
Biotech & Pharma
Regulator-ready evidence pipelines that shorten time-to-clinic.
Pain points
- IND / IMPD delays under FDA, EMA, and ICH S11 expectations
- Data loss between programs
- Regulatory uncertainty around NAMs
Value delivered
Cross-program data reuse
A shared metadata layer preserves evidence between programs and indications.
NAM & VCG readiness
Structured metadata supports new approach methodologies and virtual control groups.
Earlier go/no-go decisions
Consistent evidence and traceability improve decision quality earlier in development.
Key metric
Acceleration of time-to-clinic (pre–time-to-market)