Clinical Solutions

Clinical Solutions from Aurea Software is a document management platform for clinical trials, built around two core modules: Electronic Trial Master File (eTMF) and Trial Exchange (TRX). It is designed for life sciences organizations that need to deploy, manage, and track critical trial documents and global submissions across the full study lifecycle. Aurea positions it as comparable to Veeva in the clinical document management space.

Both modules are delivered through Aurea Compliance Manager (ACM), which also offers broader Quality Management and Regulatory capabilities under an Enterprise subscription. The platform targets sponsors, investigators, and clinical site staff who require real-time document access, compliance tracking, and streamlined collaboration.

Electronic Trial Master File (eTMF)

• Manages Trial Master Files throughout the entire study lifecycle.
• Supports completion tracking and compliance monitoring for clinical trial documents.
• Provides real-time access to TMF content for authorized users.

Trial Exchange (TRX) — Clinical Site Portal

• Delivers portal access specifically for clinical site investigators and staff.
• Allows site staff to monitor tasks, view document status, and submit documents.
• Supports communication and collaboration between sponsors and clinical sites.

Complaints and Audit Management

• Handles recording, routing, and resolution of customer complaints.
• Tracks audit observations, findings, and recommendations for complete audit management.

Enterprise Subscription Capabilities

• Includes all Aurea Compliance Manager solutions under a single subscription: Clinical, Quality Management, and Regulatory modules.
• Quality Management Systems include Change Control, Audit Management, CAPA, Deviations/Non-Conformance, and Complaints solutions.
• Also includes SOP and Training Module and Regulatory Document Management.
• Enterprise tier includes Platinum Support and all future roadmap innovations; Standard tier offers individual modules available via subscription with Standard Support.

Onboarding Process

1. Kickoff: Initial project alignment and planning.
2. Deployment: Technical setup and configuration of the solution.
3. Training: User and administrator training on the platform.
4. Pilot: Controlled rollout to validate the deployment before full go-live.

• A four-phase onboarding package is included with every Unlimited subscription for each new solution.
• Deployment timelines are estimated at 6 to 12 weeks depending on product complexity.

Aurea Clinical Solutions is available as a cloud-based deployment, as referenced in related product resources covering Aurea Solutions in the Cloud. Customers also have access to the Aurea Worx community hub for product resources, release notes, Q&A, and updates.