You own the regulatory weight across safety cases and clinical trials.

Outsourcing operations to CROs does not outsource regulatory accountability. When health authority inspectors ask how an adverse event was adjudicated or why a clinical trial missed enrollment milestones, the liability rests entirely with the sponsor.

Zen Health provides sponsors with two defensible intelligence layers:

• Zen Case AI: Objective, finding-by-finding medical review quality records on every outsourced case. Complete per-CRO quality scorecards, MedDRA version pinning, and 21 CFR Part 11 dual electronic signatures.
• Zen Protocol AI: De-risk trial execution before first patient in. 5-step ICH M11 authoring, legacy protocol conversion, and statistical Monte Carlo simulation forecasting P10/P50/P90 enrollment timelines.

Gain cross-vendor comparability when selecting your next CRO partner and present undeniable data lineage during regulatory inspections.