Autonomous Clinical Trial Management

The clinical PM that never sleeps

TrialPilot is an AI agent that handles routine clinical trial operations around the clock — timelines, site coordination, enrollment tracking, risk alerts. Your team focuses on science and oversight. TrialPilot handles the operational grind.

24/7
Continuous trial monitoring
Weeks
Earlier risk detection vs. manual review
Zero
Status meetings replaced with live dashboards
The Problem

Clinical trials cost millions. Project management still runs on spreadsheets and email.

Today's Clinical PM

  • Expensive, specialized headcount that's hard to scale
  • Weekly status meetings that could be dashboards
  • Enrollment slippage caught weeks too late
  • Site issues buried in email threads
  • Regulatory docs tracked in shared drives

TrialPilot

  • Automates routine ops; escalates exceptions for human review
  • Real-time trial dashboards, zero status meetings needed
  • Predictive enrollment alerts before sites fall behind
  • Automated site coordination and follow-ups
  • Intelligent document tracking with compliance flags and audit trail
What It Does

An employee, not a dashboard

01

Protocol Intelligence

Feed it a protocol document. TrialPilot generates your full project timeline, milestones, dependencies, and critical path. Updated continuously as reality shifts.

02

Site Coordination

Monitors every site across your trial network. Flags underperformers, tracks startup progress, and escalates issues before they derail timelines.

03

Enrollment Forecasting

Predicts enrollment trajectory per site using historical patterns. Alerts you to shortfalls weeks ahead so you can reallocate resources, not scramble.

04

Regulatory Watchdog

Tracks IRB submissions, protocol amendments, and compliance deadlines across jurisdictions. Nothing slips through the cracks at 3am.

Built for Regulated Industries

Enterprise-ready by design

TrialPilot is designed with the compliance, security, and auditability requirements of GxP environments in mind — from day one.

Data Security Active

All data encrypted in transit (TLS 1.2+) and at rest. Hosted on SOC 2 compliant infrastructure. SOC 2 Type II certification in progress.

Audit Trail & Access Control Active

Every action logged with user, timestamp, and context. Designed for role-based access control so the right people see the right data.

GxP Validation Roadmap

Designed with 21 CFR Part 11 and Annex 11 principles in mind. Validation documentation and IQ/OQ/PQ support planned for enterprise deployments.

Integration Surface Roadmap

Planned integrations with the systems your teams already use:

  • CTMS and eTMF platforms
  • EDC systems for enrollment data
  • Email, Teams, and SharePoint for coordination

What TrialPilot does autonomously vs. what it drafts for review

Activity Mode Detail
Timeline generation & updates Autonomous Auto-generates and adjusts project timelines based on protocol and site data
Enrollment monitoring & alerts Autonomous Continuously tracks enrollment pace and flags shortfalls to your team
Site status tracking Autonomous Monitors startup milestones, collects updates, surfaces blockers
Regulatory deadline tracking Autonomous Tracks IRB, amendment, and compliance deadlines across jurisdictions
Risk escalation & recommendations Human Review Drafts risk assessments and mitigation plans for your team's approval
Site communications Human Review Drafts outreach and follow-ups; sent only after team review
Protocol deviation flagging Human Review Identifies potential deviations and escalates for clinical review

Clinical trials deserve a PM that works as hard as the science

Built for biotech sponsors and CROs who need enterprise-grade oversight without enterprise-grade overhead.