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Medidata Rave EDC

by Medidata Solutions
No reviews yet
ActiveAvailable globallyCloud
Quick facts
VendorMedidata Solutions
Year launchedN/A
StatusActive
LocationMerck & Co. Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033
Countries servedGlobal
Languages6
Integrations20+
Free tierNO
Free trialNO
Contact salesYES
Last reviewed: Jun 2026

About Medidata Rave EDC

A cloud-based electronic data capture (EDC) platform for clinical trials. It enables study teams to design electronic case report forms, manage data entry, perform validation, and handle queries in a centralized, regulatory-compliant environment.

Medidata Rave EDC is a widely recognized industry-standard platform for electronic data capture in clinical trials. Designed for pharmaceutical sponsors and contract research organizations (CROs), it provides a robust, cloud-based environment for managing the entire clinical data lifecycle. The platform is highly configurable, allowing study teams to build complex electronic Case Report Forms (eCRFs) and implement data validation rules without extensive programming. Its integration capabilities are a significant strength, as it connects seamlessly with other modules in the Medidata Rave Clinical Cloud, such as CTMS, RTSM, and eCOA, creating a unified ecosystem that reduces manual data entry and reconciliation. While the platform is powerful and scalable for large global trials, its depth of functionality requires significant training for study builders and data managers. It is a critical tool for organizations that need to maintain strict regulatory compliance while managing high-velocity data across multiple sites and countries.

Pros & Cons

Pros
  • Industry-standard platform with proven reliability for complex global clinical trials.
  • Unified ecosystem integrates seamlessly with other clinical trial management modules.
  • Highly configurable study design tools reduce the need for custom coding.
  • Robust audit trails and compliance features support regulatory requirements.
  • Scalable architecture supports trials ranging from small early-phase studies to massive global programs.
Cons
  • Steep learning curve for study builders and data managers due to the platform's extensive feature set.
  • Configuration and setup can be time-consuming for complex study protocols.
  • Pricing is typically enterprise-level and not publicly disclosed, requiring direct sales contact.

Features

Key features

Electronic Data Capture

Provides a configurable interface for designing electronic Case Report Forms (eCRFs) to capture clinical trial data.

Data Validation

Supports programmed edit checks and validation rules to ensure data quality at the point of entry.

Query Management

Automates the generation and tracking of data queries to streamline the data cleaning process.

Audit Trail

Maintains a comprehensive, regulatory-compliant log of all data changes and system activities.

Study Design

Uses drag-and-drop tools to build visit schedules and forms without requiring custom coding.

Additional features

Multi-Language Support

Allows for simultaneous use of multiple languages within a single study database.

Real-Time Reporting

Provides dashboards and metrics for monitoring study progress and data status.

Regulatory Compliance

Built to support 21 CFR Part 11 and GCP compliance requirements.

Integration Hub

Connects with other clinical systems like CTMS, eTMF, and RTSM for unified data flow.

Version Control

Manages study design updates and form changes without requiring system downtime.

Role-Based Access

Controls user permissions to ensure data security and appropriate access levels.

Safety Gateway

Automates the transmission of adverse event data to pharmacovigilance systems.

Imaging Management

Centralizes the upload and review of medical imaging data for clinical endpoints.

Pricing

Free trial
Free version
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Countries & Languages

Global
Countries served
6
Interface languages
17
Billing currencies

Interface languages

EnglishSpanishFrenchGermanItalianPortuguese

Billing currencies

🇺🇸USD🇪🇺EUR🇬🇧GBP🇦🇺AUD🇨🇦CAD🇯🇵JPY🇨🇭CHF🇨🇳CNY🇮🇳INR🇸🇬SGD🇭🇰HKD🇰🇷KRW🇿🇦ZARJOD🇦🇪AED🇲🇽MXN🇧🇷BRL

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