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What is Rave EDC?

Medidata's Rave EDC (Electronic Data Capture) is recognized as the leading system for effectively handling clinical trial data from various sources like sites, patients, and laboratories, ensuring both sophistication and security. As a key component of the Medidata Clinical Cloud™, it provides an all-encompassing platform that harmonizes multiple processes, thus removing the need for data reconciliation and enabling thorough data analysis across various studies and functions. Users are able to manage their responsibilities, studies, and sites through a unified dashboard that integrates all Rave EDC and other Medidata Clinical Cloud tools. This platform significantly reduces the risks of duplicate study master data and discrepancies, such as inconsistent IDs for identical sites across different applications. Central to Medidata’s unified strategy for Clinical Data Capture and Management, Rave EDC supports the smooth collection and reconciliation of data from an array of sources, including Medidata eConsent, Medidata eCOA, MyMedidata, Rave RTSM, Rave Imaging, and Sensor Cloud; it also bolsters data review and analysis with sophisticated tools like Rave TSDV and Medidata Detect. By offering these advanced functionalities, Rave EDC not only streamlines the data management process but also empowers clinical researchers to make well-informed decisions grounded in trustworthy and comprehensive data insights. Therefore, it plays an essential role in enhancing the overall efficiency and effectiveness of clinical trials.

What is Greenlight Guru Clinical?

Medical device and diagnostics companies running clinical studies are often stuck configuring EDC software that was built for pharmaceutical trials and never designed around FDA, EU MDR, IVDR, or ISO 14155 requirements. Greenlight Guru Clinical solves that by being the only electronic data capture (EDC) system built from the ground up for medtech, so teams aren't reworking someone else's pharma template to fit a device study. Designed exclusively for medtech, Greenlight Guru Clinical combines an easy to use clinical data platform with industry leading customer service, so teams generate reliable, compliant clinical data with confidence. Get a single, validated platform covering the full lifecycle of a device or diagnostics study, including: Electronic Data Collection and eCRF design, with GCP compliant structures and built in audit trails ePRO/eCOA for patient and clinician reported outcomes, collected in person or remotely on any device eConsent for compliant, auditable enrollment Randomization (RTSM) for controlled and comparative studies PMCF Surveys for post market clinical follow up under EU MDR Adverse Events Reporting built into the platform Leading-edge, open API for connecting study data to other clinical or quality systems Greenlight Guru Clinical supports pre-market clinical investigations, post-market surveillance studies, registries, and human factors testing, and is used by both device and diagnostics manufacturers and by contract research organizations (CROs) that specialize in medtech. A validation package is included with every product update, removing the ongoing burden of software revalidation from the quality team. Every customer also gets a dedicated customer success manager with real medtech experience, not a generalist software account rep. For manufacturers already on Greenlight Guru's quality management system (QMS), Clinical extends into one connected platform spanning quality, product development, and clinical evidence.

Media

Media

Integrations Supported

Medidata
Rave CTMS

Integrations Supported

Medidata
BSI CTMS
ChatGPT
Claude
Cursor
Gemini
Oracle Clinical One
Prelude EDC
Tremendous
Veeva Vault

API Availability

API Availability

Has API

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Webinars
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Dassault Systèmes

Date Founded

1981

Company Location

France

Company Website

www.medidata.com/en/clinical-trial-products/clinical-data-management/edc-systems

Company Facts

Organization Name

Greenlight Guru

Date Founded

2013

Company Location

Denmark

Company Website

www.greenlight.guru/clinical-electronic-data-capture-software

Categories and Features

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Scheduling
Study Planning

Electronic Data Capture

Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management

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