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mondotwin/mondotwin-researcher

v0.7.4

Seven clinical-research skills on mondoTWIN's trial-registry and regulatory-guidance database: benchmark similar trials, count and compare registered trials with read-only SQL, report which endpoints and comparators the trials of an indication used and how they fared, review a protocol section against ICH, draft eligibility criteria from comparable trials, choose endpoints and estimands, and look up ICH or FDA guidance with quoted passages. Includes the mondoTWIN connector (OAuth sign-in).

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skills

protocol-section-review

Review a draft clinical trial protocol or synopsis section (objectives, endpoints, eligibility criteria, sample size rationale, schedule of activities) against comparable registered trials and ICH E6(R3), E8(R1), E9(R1) and M11, and return numbered, reasoned changes, each backed by trial registry ids or a quoted guideline passage and marked "to validate". Use when the user pastes or describes part of a protocol and asks for a review, critique, gap check, improvements, or consistency with ICH or with what similar trials did.

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