Medidata Rave Features

Hosts the EDC system in the cloud and provides data security

Sets up and determines designated permission levels for users

Auto-generates or simplifies the manual addition of queries that require action in order to lock data

Eases the export of clinical data for tracking and reporting purposes

Facilitates the creation and storage of electronic case report forms and templates

Tracks history of and any changes made to eCRFs or captured data

Provides 1 or more methods to electronically collect clinical trial data

Manages patient enrollment and study randomization

Ensures compliance with regulatory requirements like 21 CFR Part 11

Offers customizable dashboards and analytics to track completeness, compliance, quality, and timeliness of the study.

Offers a pre-built DIA TMF reference model hierarchy, and allows for configurable reference models to meet the specific needs of organizations and sponsors.

Supports inspections and regulatory audits by maintaining inventory and document reports, and having pre-built compliance with all relevant regulatory guidelines.

Designates customizable user roles and limit access to certain functions in the eTMF.

Allows users to upload multiple documents at once and provides dynamic indexing options.

Manages the status of all trial documentation at all stages and flags missing documentation.

Tracks each version of a document and shows changes from each version or reupload.

Allows documents and metadata to be easily searched within the system.

Establishes study level, country level, and site level milestones and what amount of mandatory and optional documents need to be collected throughout the study lifecycle.

Allows external or remote contributors to upload documents and work collaboratively in a controlled method.

Configures review, e-signature, and approval workflows for all documentation.