Medidata Rave

The industry’s leading unified EDC and CDMS solution

Medidata Rave is the world’s leading solution for capturing, managing and reporting patient data, including unified EDC, CDMS and lab administration features. Rave is the cornerstone of the Medidata Clinical Cloud and allows you to seamlessly add Medidata’s randomization, trial supply, medical coding, safety reporting and mobile health capabilities as your organizational needs grow.

Medidata Rave is:

  • Flexible. Don’t twist your processes to fit technology limitations. Rave flexibility accommodates your workflow requirements. Make mid-study changes—including adaptive trials, protocol amendments and updated requirements—easily with no system downtime. Medidata Rave manages multiple case report form (CRF) editions and seamlessly migrates existing data into new forms and structures.
  • Scalable. Medidata Rave’s cloud-native architecture scales from one study to hundreds, and from Phase-I all the way to global Phase-IV. Whatever your trial phase or business growth, one cloud system is all you need.
  • Configurable. Simple or complex study requirements, Medidata Rave handles them all without custom programming. Easily configure CRFs, workflows, data blinding, source document verification (SDV) requirements, dictionary coding and more. All via a point-and-click browser interface.

Medidata Rave goes beyond traditional EDC and offers value added data management and reporting capabilities.

Medidata Rave

EDC CDMS

Cloud Hosting

  • Fully-managed, scaled hosting

  • Fully-managed, scaled disaster recovery

Database Capacity

  • Unlimited study database size

  • Access to unlimited database capacity at no extra charge

Help Desk & eLearning Support

  • Unlimited help desk support

  • Integrated, unlimited eLearning

Study Build, Data Capture & Data Integrity

  • Dynamic CRF workflow and branching at the field, form and folder level

  • Investigator signature

  • Real-time field-level edit checks

  • Real-time cross-form edit checks

  • Real-time data derivations

  • Configurable intelligent data management and clinical operations workflows

  • Study-specific configuration options for data entry and view permissions (e.g. blinding, endpoint adjudication)

  • Viewing, updating, querying and locking data

  • Self-service creation of multiple study environments for DEV, UAT, TRAIN, PROD and OTHER

  • Self-service deployment of CRFs to any environment

  • Self-service unlimited mid-study changes in any environment

  • Self-service administration of users, studies and sites

  • Role-specific task lists

  • Ability to track multiple role-based reviews, e.g., medical monitor or safety

  • Ability to raise queries directly to site with no need for candidate query review
  • Ability to track SDV
  • Ability to track SDR

Audit

  • Fully-integrated user-accessible audit trail

Reporting

  • 49 standard out-of-the-box reports

  • Unlimited ad hoc, user-driven reports

  • Operational metric reporting

  • Unlimited reporting licenses

  • Self-service role-based report administration

PDF & SAS Dataset Generation

  • Self-service unlimited blank PDF generation

  • Self-service unlimited annotated PDF generation

  • Self-service patient data PDF generation

  • End of study PDFs & media generation

  • Self-service unlimited online SAS dataset generation

Data Integration

  • Unlimited use health record (EMR/EHR) integration APIs

  • Unlimited web service data integration access

  • Unlimited batch file data uploads

  • Self-service unlimited central and local lab administration

Standards Management

  • Global Library to enable reuse of standard forms and form components

  • Spreadsheet exporter/loader for offline study design and metadata sharing

Data Management

  • Query management facility for bulk management of queries

  • Unlimited self-service batch data management & clinical operations functions, e.g., reviewing, verifying, freezing and locking data (by form, visit, patient, site)

  • Complex sponsor/site/CRO query workflows

Value-Added Services

  • eCRF creation services

  • Custom function creation services

  • Global Library best practices services