Medidata Rave EDC logo

Medidata Rave EDC

by Medidata Solutionsmedidata.com
VISIT OFFICIAL WEBSITE →

OVERVIEW

The industry's most advanced Electronic Data Capture (EDC) system for capturing, managing, cleaning, and reporting clinical trial data across Phase I-IV studies.

Medidata Rave EDC is the cornerstone of the Medidata Platform, a highly scalable Software-as-a-Service (SaaS) solution for clinical research. It unifies electronic data capture (EDC) and advanced clinical data management (CDM) capabilities, streamlining workflows and eliminating data reconciliation.

The system is designed for flexibility, supporting complex study designs, adaptive trials, and mid-study changes with minimal effort and no system downtime. Its intuitive, web-based interface is user-friendly for investigators, coordinators, and CRAs, supporting multiple languages for global studies. Users benefit from a single sign-on portal for all their studies.

Rave EDC provides real-time data validation, comprehensive audit trails, and fast data access via the ODM Adapter and Web Services. Key features include unified Randomization and Trial Supply Management (RTSM), Query Management, and seamless integration with other eClinical applications like eCOA, CTM, and safety reporting systems. The platform is utilized by pharmaceutical and biotech companies, CROs, and academic institutions for a wide range of trials, including post-marketing observations and registries.

RATING & STATS

User Rating
4.6/5.0
50 reviews
Customers
1,000+
Founded
1999

KEY FEATURES

  • Electronic Case Report Forms (eCRFs)
  • Unified Randomization and Trial Supply Management (RTSM)
  • Real-time Data Validation and Edit Checks
  • Query Management
  • EHR to EDC Data Integration (Rave Companion)
  • Centralized Clinical Data Management (CDM)
  • Role-Based User Permissions

PRICING

Model: enterprise
Not publicly disclosed. Subscription-based with a tailored, adaptable pricing structure that scales according to trial needs, including a cost-effective Rave Lite option for Phase I and Phase IV trials.

TECHNICAL DETAILS

Deployment: saas, cloud, hybrid
Platforms: web, windows, mac, ios
📱 Mobile Apps🔌 API Available

USE CASES

Clinical Data Capture and Management (Phase I-IV trials)Adaptive Clinical TrialsPost-Marketing Observations and RegistriesSite and Data Monitoring and Oversight

INTEGRATIONS

eClinical applications (eCOA, CTM, coding, safety reporting systems)Data WarehousesIVR/IWR systemsEHR (Electronic Health Record) systems

COMPLIANCE & SECURITY

Compliance:
FDA 21 CFR Part 11HIPAAGDPRGXPISO 27018SOC2
Security Features:
  • 🔒Data Encryption (AES-256)
  • 🔒Role-Based Access Control
  • 🔒24/7 Monitoring
  • 🔒Security Assessments/Penetration Testing
  • 🔒Single Sign-On (SSO)

SUPPORT & IMPLEMENTATION

Support: email, phone, on-demand training
Target Company Size: small, medium, enterprise
TRAINING AVAILABLE

PROS & CONS

✓ Pros:
  • +Extremely user-friendly and intuitive interface (G2 score 9.5)
  • +Highly flexible and customizable for any study phase or therapeutic area
  • +Unified platform eliminates need for separate systems (e.g., RTSM)
  • +Robust security and compliance (21 CFR Part 11, HIPAA, GDPR)
  • +Supports mid-study changes with no system downtime
✗ Cons:
  • -Reports can sometimes take too long to download
  • -Costing seems to be high for small companies (implied by enterprise focus)
  • -Quick logoff due to inactivity (security feature, but a con for users)

ABOUT MEDIDATA SOLUTIONS

Other software by Medidata Solutions:
Medidata DCT (Clinical Development SoftwareDecentralized trial infrastructure)
Medidata RTSM (Clinical Development SoftwareRandomization and trial supply management)