Automated aggregate safety drafts and submission-ready protocol packages.
Eliminate manual drafting bottlenecks. From safety databases to compiling ICH M11 protocol packages with Monte Carlo feasibility timelines, Zen Health delivers scientifically rigorous outputs ready for physician sign-off.
Zen Health delivers automated drafting across safety and protocol operations.
We extract evidence, populate regulatory tables, and compute statistical models so your clinical and safety teams can focus strictly on final review and sign-off.
Automated ICSR Extraction
Extracts structured and unstructured ICSR data from safety systems (Argus, ArisG, Veeva) and populates periodic safety sections, adverse event line listings, and exposure summaries.
Integrated Signal Correlation
Cross-evaluates adverse event reporting trends, lab deviations, and signal thresholds to surface critical safety findings across clinical domains into regulatory narratives.
ICH M11 Structured Protocol Packages
Compiles fully structured protocol documents across 133 ICH M11 sections, including schedule of activities, objective endpoints, and USDM data models with zero manual formatting errors.
Monte Carlo Feasibility Reports
Generates exportable feasibility dossiers featuring Probability of Success (PoS) scores, site-by-site enrollment curves, P10/P50/P90 completion dates, and sensitivity bottleneck levers.
Ready to automate your safety reports and protocol packages?
Run a pilot using a sample from your historical safety database or test our protocol feasibility compiler on an active trial concept.