Trialomics EDC Bundle – Powered by Picard

🔧 What’s Inside

This package demonstrates how we deliver full-cycle clinical data infrastructure, including regulatory-grade systems, patient-facing apps, and secure cloud environments.

📱 Application Documentation

• Android App User Guide – Instructions for using the clinical-grade mobile application.
• Sana Android & iOS Screens v4 – UI/UX mockups and final screen references.
• Sana Clinical Trial Documentation – Overview of trial setup and application workflow.

✅ Validation & Testing

• Picard Software Validation – System-level testing and validation strategy for Picard.
• Clinical App & Database Verification – Verification matrix aligned to clinical use cases.
• Traceability Matrix – Mapping of requirements to test cases for regulatory alignment.

☁️ Compliance & Hosting (Picard Platform)

The Picard platform is a secure, scalable cloud environment designed for regulated data collection and analysis. This bundle includes:

• HIPAA & ISO Policies – Security and privacy documents covering encryption, access control, breach notification, and more.
• Periodic Task Ledger – Audit trail of key compliance and operational tasks.
• Risk Analysis & Management – Risk assessments and mitigation plans.

📄 Sample Agreements

• Software and Support Agreement – Example contractual terms covering deployment and support of the EDC infrastructure.

🚀 Why This Matters

Clinical EDC requires more than just software. It demands a coordinated system of technology, compliance, and clinical context. Our approach brings these together through:

• End-to-end control over app development and hosting
• Regulatory-compliant documentation and traceability
• Scalable systems that work for clinical trials and commercial products