H1ST-AI-DEN-002 · Task 2.2
Queries shouldn't age out in a spreadsheet
Every query stalled between a site's answer and the EDC update is a day added to your lock. The Query Automation Agent plugs into your existing query workflow, auto-populates responses from chat and site answers, tracks every query's status in real time, and enforces escalation rules so nothing ages out silently — cutting resolution time by up to 40% without changing how sites work.
The grind you know
Query management runs on a manual relay you're tired of: a coordinator answers in email or chat, one of your data managers retypes it into the EDC, and the real status lives in a spreadsheet someone updates when they can. Aging queries slip out of sight until a monitoring visit puts them back on the table, and your lock date drifts because the open-query pile never quite clears.
Part of the Clinical Data Capture family
Source-document extraction & query automation.
Every query stalled between a site's answer and the EDC update is a day added to your lock. The Query Automation Agent plugs into your existing query workflow, auto-populates responses from chat and site answers, tracks every query's status in real time, and enforces escalation rules so nothing ages out silently — cutting resolution time by up to 40% without changing how sites work.
The agent integrates with the EDC's existing query engine — no change to how sites open or answer queries.
As answers arrive in chat or correspondence, it auto-populates the matching query response and categorizes the query.
Status updates in real time, and escalation rules route aging or high-priority queries to the right owner with notifications.
Capabilities
Reads answers captured in chat or site correspondence and populates the corresponding query response, so a data manager confirms rather than re-types.
Gives every query a live visual status — open, answered, closed — updating in under five seconds so teams always know where each item stands.
Applies configurable escalation rules by query age, type, and priority, routing overdue or high-severity queries to the right owner before they threaten timelines.
Classifies queries as data clarification, missing data, or protocol deviation, and supports batch actions and notifications so large query sets are handled in one pass.
In practice
Where the agent shows up in the day-to-day of a live trial — the moments the grind usually lives in.
A coordinator replied to a query in chat days ago, but it still sits open because no one retyped it into the EDC. The agent reads the answer from the correspondence and auto-populates the query response, staged for a data manager to confirm.
A protocol-deviation or safety-related query slips out of view until a monitoring visit puts it back on the table. Age- and priority-based escalation routes it to the responsible owner before it ages past its threshold, so nothing overdue stays silent.
Following a data cut you're staring at a large batch of queries to categorize and route. Batch operations classify them as data clarification, missing data, or protocol deviation and notify affected sites and owners in a single pass.
Proof
Figures shown are pre-launch targets based on internal benchmarks, not guaranteed outcomes.
Medidata Rave
EDC
Oracle Clinical
EDC
Veeva Vault
EDC
Who it's for
Compares submitted data against expected fields to find gaps, then generates context-aware queries to close them.
Learn moreExtracts structured trial data from source documents with OCR and clinical NLP, de-identifying PHI as it reads.
Learn moreRuns configurable monitoring rules and Key Risk Indicators, surfacing findings on a severity-ranked dashboard.
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.
