PI Summary and Review Agent

The PI Summary and Review Agent by Medable is an intelligent AI assistant designed to streamline and accelerate the Principal Investigator (PI) review process in clinical trials. Built for clinical research sites and study teams, it continuously monitors eCOA and Medable-collected participant data, then prepares PIs for review and sign-off with full transparency and human-in-the-loop control. As noted by Medable's Chief Medical Officer, Dr. Pamela Tenaerts, regulators expect satisfactory oversight of remotely captured data — a requirement that traditionally forced PIs to verify content across multiple reports and systems. This agent centralizes that effort, making remote oversight seamless.

The agent is purpose-built to reduce site burden without disrupting ongoing trial activity, ensuring that compliance and oversight obligations are met efficiently while participants and site staff continue their work uninterrupted.

Core Capabilities

• Real-time eCOA data review readiness: Continuously monitors and organizes Medable-collected participant eCOA data so that PI reviews are always current and up to date, giving investigators a complete picture at any moment.
• Full transparency through underlying data: Every summary is backed by the full participant data record. PIs can review individual responses, draft changes, and make updates before signing, with a clear audit trail showing exactly what was reviewed and when.
• Non-disruptive review and sign-off: The review and sign-off workflow operates without blocking site or participant activity, allowing trials to keep moving forward while oversight remains on track.
• Human-in-the-loop control: The agent acts as an assistant rather than an autonomous decision-maker, ensuring that PIs retain complete control over the review process and final sign-off decisions.

Key Benefits for Clinical Research Teams

• Reduces the manual effort required for PIs to verify participant data across multiple systems and reports.
• Centralizes eCOA data oversight into a single, organized view, simplifying regulatory compliance.
• Supports satisfactory oversight of remotely captured data as expected by regulators.
• Enables seamless remote oversight, particularly valuable for decentralized and hybrid trial models.
• Maintains a clear, auditable record of what data was reviewed, by whom, and when.

Workflow Overview

1. The agent continuously monitors incoming eCOA and participant data collected through the Medable platform.
2. It organizes and summarizes the most recent participant data, preparing it for PI review.
3. The PI accesses a centralized, transparent summary with full access to the underlying data.
4. The PI reviews responses, drafts or makes any necessary changes, and proceeds to sign-off.
5. All review activity is logged with complete transparency, supporting audit readiness and regulatory compliance.

The PI Summary and Review Agent is part of Medable's broader suite of AI agents and is accessible through the Medable Studio platform. It is designed to integrate into existing clinical trial workflows without disruption, supporting the compliance and oversight requirements associated with remotely captured data in modern decentralized and hybrid clinical trials.