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Medidata Remote Source Review

Medidata Remote Source Review

Drive efficiencies and speed with secure remote monitoring

Remote site monitoring is no longer a “nice-to-have.” Continued success in clinical trial operations now requires a dedicated remote site access and monitoring strategy. Imagine reducing the need for on-site document review, while reviewing documents faster, mitigating risk AND reducing site burden. Medidata Remote Source Review is a cloud-based solution that rapidly and remotely enables monitors to acquire critical documents, automates document workflows to the right monitor for the right study and site, and allows them to review documents to support Source Data Verification (SDV) and Source Document Review (SDR).

Medidata Remote Source Review

Secure, remote monitoring of critical source documents helps keep your trials running smoothly.

Why Medidata Remote Source Review?

Save Costs in Monitoring Visits

Remote Monitoring of critical source documents reduces the costs of monitors prepping for and going on-site for SDV/SDR, eliminating site travel and per diem costs for those visits.

Reduces Site Burden

With simple upload and redaction tools, and automated workflow/task management, the time sites need to spend preparing for monitoring visits for SDV/SDR is greatly reduced. Remote Source Review is connected to Rave EDC, if applicable, to automatically create study subjects, reducing time spent entering data.

Improve Efficiency and Speed

Off-site/remote monitoring removes travel time allowing for improved speed to review documents and expedites time to first data review. Accelerated data capture and time to read improves efficiency in the management of trials.

Ensure Data Quality & Compliance

Medidata Remote Source Review is a 21 CFR Part 11 compliant system and protects PII and PHI with built-in redaction functionality that helps reduce errors.  Intelligent workflows and flexible permissions enable automatic distribution of source documents to the right monitors for their assigned sites. A full audit log and documentation helps track and re-verify data, reducing the risk of failing an audit.

Gain Oversight, Control and Visibility

Remote Source Review provides a series of standard reports for task management and status updates and improves oversight with a full audit trail that captures all activities.  Electronic documents are available for review immediately upon upload.

Medidata partners with CTI for Remote Source Review of Clinical Trials in Response to COVID-19