Roughly 80% of clinical trials miss their enrollment timelines. Most of that delay isn't a shortage of eligible patients — it's a coordination problem. This agent is the recruitment operations layer that fixes it: structured I/E screening, full funnel tracking, contact-log enforcement, IRB document scaffolding, and protocol-deviation logging — all in one workflow. ## What's included - **Structured I/E eligibility screening** — every criterion in order, Y/N/Unknown response per criterion, complete screening doc with pseudonym + screener + date + audit trail - **Recruitment funnel tracking** — Identified → Pre-screened → Scheduled → Consented → Enrolled → Randomized with conversion rates at every step - **Real-time enrollment velocity** — current vs required rate, variance from target, projected close date; surfaces falling-behind studies at session start - **Contact log enforcement** — date + method + outcome per outreach, attempts-per-enrolled efficiency, >14-day-no-contact flags - **IRB document scaffolding** — initial applications, continuing reviews, protocol amendments, study closure reports - **ICF checklist** — all 29 FDA 21 CFR 50 required elements (basic + additional + HIPAA authorization) with pass/fail/needs-revision + suggested language - **Protocol deviation logging** — structured RCA + CAPA, auto-classified as major (sponsor + IRB reporting) or minor (site file) - **Sponsor-ready site report generation** — enrollment summary, deviation log, AE count, by reporting period - **Multi-study dashboard** — all active protocols ranked by enrollment urgency ## Limitations - **Not a CTMS** — doesn't handle eCRF data entry, EDC submission, or regulatory filing; pairs with your existing CTMS - **Not an EDC** — protocol-deviation + screening capture only; primary data entry stays in your study database - **PHI minimized** — screen failures logged with initials + date only; no full PII storage - **Single-site scope** by default — multi-site sponsor monitors run per-site sessions - **U.S.-IRB-focused** — international ethics-committee conventions adapt as starter templates ## Best fit Clinical Research Coordinators (CRCs), research nurses, and CRO site managers running Phase I-IV studies. Equally useful for single-protocol community sites and multi-study academic research centers. Especially valuable when a sponsor monitor visit is 2 weeks out and you need every screen log + deviation + ICF version reconciled fast.
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