One unified workspace.

Watch the study breathe.

Continuous safety surveillance over the whole study — exposure-adjusted rates, rising trends flagged as they form, and explainable triage that decomposes every score into factors a reviewer can inspect, accept or override. Expectedness checks read events against the reference safety information, so “novel” is grounded in your IB, not guesswork.

• Live signal surveillance while the trial runs
• Explainable triage with inspectable factors
• Expectedness grounded in the reference safety information
• Case narratives drafted where the data lives, edited in place

Ask in plain English. Get cited answers.

Every reviewer — safety physician, data manager, biostatistician, regulatory writer — asks questions in one conversation and gets clear, source-backed answers. Deep-linked to the records behind them. The part we care most about: every answer is auditable and fully cited. No evidence, no answer.

• One chat across every data domain in the workspace
• Typed, cited answer blocks with deep links to the source
• The tool catalog adapts to the study you're in
• Provenance carried on every analytics answer

Statistics reviewers can check.

Clinical-pharmacology engines that compute deterministically, aligned to the guidance your reviewers expect — bioequivalence including high-variability and narrow-therapeutic-index criteria, biosimilar PK similarity against prespecified margins, a confirm-before-counting immunogenicity cascade, and conformance rules that run on every sync.

• Bioequivalence: ratios, intervals and scaled criteria
• Biosimilar PK similarity vs prespecified margins
• Multi-tier immunogenicity — only verified positives counted
• Data-quality conformance on every sync; flags become trackable queries

From deviation to dossier.

Protocol deviations arrive traced — the broken rule paired with the data that broke it — and flow into ICH-structured listings and letters. Study reports build themselves section by section, gated by readiness checks, and rebuild when data changes. Safety reports go out in the exact format regulators require, transmitted to your safety database with acknowledgments tracked.

• Rule-linked deviation evidence and severity rationale
• Self-rebuilding study reports gated by readiness checks
• E2B(R3) reports transmitted to the safety database, ACK-tracked
• Pathway-aware eCTD packaging with checksums