Documents, Operations & Support · H1ST-AI-PM-007
Action items, status, deviations & comms.
The problem this family owns
This is the stretch of the trial where the work is repetitive, deadline-bound, and unforgiving of small errors — the part a stretched team feels first, and the part where a missed detail is most expensive to fix later.
The Clinical Project Management family puts a purpose-built agent on each of these. You stay in control of every output — the agents absorb the grind, not the judgment.
Where it fits
The AI program manager. Clinical Project Management extracts action items from email, keeps study and site status dashboards current, tracks protocol deviations and CAPAs, reviews safety, and runs site and physician communication.
It sits in the Documents, Operations & Support suite — a compliant etmf and an ai project team — and is delivered as 6 individually-deployable AI agents you can adopt one at a time or as a complete workflow.
The agents
Each agent below removes a specific piece of that grind. Deploy the whole family as one workflow, or add the single agent that hurts most today and expand from there.
An AI agent that reads project email and meeting notes to extract action items, assign owners, and track them to closure.
Learn moreAutomated study and site status dashboards with executive summaries, KPIs, and threshold alerting.
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 moreAutomated site emailers for milestones, reminders, and status, plus periodic study newsletter generation and distribution.
Learn moreA consented, compliant-channel WhatsApp workflow for physician and site-team notifications, response capture, and AI-driven next steps.
Learn moreOne workflow, not point tools
Enabled together, the Clinical Project Management agents hand off in sequence — each one's output becomes the next one's input, so nothing is re-keyed and nothing falls between the seams.
An AI agent that reads project email and meeting notes to extract action items, assign owners, and track them to closure.
Automated study and site status dashboards with executive summaries, KPIs, and threshold alerting.
Protocol-deviation tracking and categorization with integrated CAPA management aligned to ICH E6.
SAE and SUSAR tracking with automated reconciliation between the EDC and the safety database.
Automated site emailers for milestones, reminders, and status, plus periodic study newsletter generation and distribution.
A consented, compliant-channel WhatsApp workflow for physician and site-team notifications, response capture, and AI-driven next steps.
Built for regulated trials
Every agent runs inside a validated, audit-ready platform aligned to the standards clinical teams and inspectors expect.
Electronic records and signatures with full audit trails, access controls, and validation.
Good Clinical Practice, including risk-based quality management and computerized-system expectations.
Standards-based data capture, tabulation, and analysis datasets that validate clean in Pinnacle 21.
PHI safeguards, de-identification, and role-based access across the platform.
Lawful processing, data-subject rights, and EU data-residency support for global trials.
Security, availability, and confidentiality controls audited against Trust Services Criteria.
Certified information-security management system governing the whole platform.
AI management system for responsible, governed, and auditable use of AI.
Straight answers
Pulled from the questions teams ask most about the agents in this family — answered plainly, including where the honest answer is a limit.
No pitch, no pressure — a working walkthrough on your own workflow and honest answers, including on the limits. Bring the study that worries you most.
