H1ST-AI-PM-007
Your weekly deck shouldn't be stale on arrival
You should see a site slipping while there's still time to act, not read about it in next week's deck. The agent aggregates study startup, enrollment, and site-performance data into live dashboards, generates narrative executive summaries for sponsors and CROs, and monitors KPIs against thresholds, raising alerts when metrics drift. Teams stop assembling status decks by hand and work from a continuously current view instead.
The grind you know
Every week you pull numbers from a handful of systems into slides that are already stale by the time anyone opens them, and it is a grind that never ends. Leadership still lacks a consistent, real-time view of startup progress and site performance. So the problems that matter, slow enrollment, a lagging site, get noticed late, after they've already cost you timeline.
Part of the Clinical Project Management family
Action items, status, deviations & comms.
You should see a site slipping while there's still time to act, not read about it in next week's deck. The agent aggregates study startup, enrollment, and site-performance data into live dashboards, generates narrative executive summaries for sponsors and CROs, and monitors KPIs against thresholds, raising alerts when metrics drift. Teams stop assembling status decks by hand and work from a continuously current view instead.
Explore the Clinical Project Management familyThe agent pulls operational data from EDC, CTMS, and startup trackers into a unified model.
It renders dashboards for startup, enrollment, and site KPIs with drill-down and benchmarks.
Metrics are checked against thresholds, and breaches generate summaries and alerts to the right stakeholders.
Capabilities
Track site activation milestones, cycle times, and bottlenecks across the startup portfolio in one view.
Monitor enrollment, query rates, and data timeliness per site with benchmark comparisons.
The agent writes concise narrative summaries of status, trends, and risks for leadership audiences.
Configurable thresholds trigger alerts when KPIs breach targets so issues surface early.
In practice
Where the agent shows up in the day-to-day of a live trial — the moments the grind usually lives in.
You'd normally spend the morning pulling numbers from EDC and CTMS into slides that are stale by lunch. The agent aggregates them into a live dashboard and writes a narrative executive summary, so leadership reads a current view instead of last week's snapshot.
One site's enrollment drifts below the study benchmark. Site-performance KPIs shown against portfolio benchmarks make it stand out, and a threshold breach alerts the PM two weeks earlier than a manual review would.
Query aging at a site crosses your target. The configurable threshold fires an alert to the right stakeholder with a summary, so the issue is actioned before it costs timeline.
Proof
Figures shown are pre-launch targets based on internal benchmarks, not guaranteed outcomes.
Medidata Rave
EDC
Veeva Vault
EDC
Who it's for
An AI agent that reads project email and meeting notes to extract action items, assign owners, and track them to closure.
Learn moreProtocol-deviation tracking and categorization with integrated CAPA management aligned to ICH E6.
Learn moreSAE and SUSAR tracking with automated reconciliation between the EDC and the safety database.
Learn morePeace of mind
Every output is generated inside a validated, audit-ready platform, kept under human-in-the-loop control, and mapped to the regulatory and CDISC standards this agent supports.
Walk through it on your own workflow with a clinical-trials expert — no pressure, no obligation, and honest answers, including on the limits.
