Medidata Rave Safety Gateway
Accelerating the transfer of clinical safety data.
Overview
Medidata's Rave Safety Gateway is a component of its clinical trial platform that automates the process of transferring serious adverse event (SAE) data from the Rave EDC (Electronic Data Capture) system to a company's pharmacovigilance/safety system. This eliminates the need for manual, duplicate data entry, reducing errors, improving reconciliation, and accelerating the safety reporting timeline. It acts as a crucial bridge between clinical data collection and safety case processing.
✨ Key Features
- Automated transfer of SAE data from EDC to safety systems
- Pre-validated connections to leading safety systems (e.g., Argus, ArisG)
- Reduces manual data entry and errors
- Accelerates safety reporting timelines
- Improves data consistency and reconciliation
- E2B and E2B(R3) format support
🎯 Key Differentiators
- Seamless, native integration with the market-leading Rave EDC
- Pre-built and validated connectors to major safety systems
- Proven solution used in thousands of clinical trials
Unique Value: Automates and accelerates the flow of critical safety data from the point of capture in a clinical trial to the pharmacovigilance system, ensuring speed, accuracy, and compliance.
🎯 Use Cases (3)
✅ Best For
- Used by numerous sponsors and CROs running clinical trials on the Medidata platform to streamline their safety data workflow.
💡 Check With Vendor
Verify these considerations match your specific requirements:
- Organizations not using Medidata Rave EDC for their clinical trials.
- Post-marketing pharmacovigilance where data does not originate from an EDC.
🏆 Alternatives
Offers a more reliable, validated, and efficient solution than manual data entry or building custom, non-validated integrations.
💻 Platforms
🔌 Integrations
🛟 Support Options
- ✓ Email Support
- ✓ Live Chat
- ✓ Phone Support
- ✓ Dedicated Support (Enterprise tier)
🔒 Compliance & Security
💰 Pricing
Free tier: NA
🔄 Similar Tools in Risk Management
Drata
Automates security and compliance to help companies achieve and maintain certifications like SOC 2 a...
Vanta
Automates security and compliance to help businesses get audit-ready in weeks....
Secureframe
Helps companies get and stay compliant with standards like SOC 2, ISO 27001, and HIPAA....
LogicGate (Risk Cloud)
A no-code, agile platform for automating and managing GRC processes....
OneTrust
A platform for privacy, GRC, ethics, and ESG....
AuditBoard
A unified platform for audit, risk, and compliance management....