Medidata Detect | Comprehensive Data and Risk Surveillance
Medidata Detect is a powerful data surveillance and centralized monitoring solution which gives cross-functional teams the ability to monitor and mitigate risks to patient safety and data integrity.
Medidata Detect includes modular capabilities which aid planned risk monitoring such as:
- Key Risks Indicators (KRIs) and Quality Tolerance Limits (QTLs)
- Machine learning capabilities to identify data anomalies and trends
- Targeted analyses to identify site performance issues, fraud and misconduct
- Features to support robust data review, at the individual patient and at the aggregated level
Powered by data aggregated from many sources on the Medidata Clinical Cloud®, Medidata Detect provides both data management and operational teams with insights delivered in time to take corrective actions.
Why Choose Medidata Detect?
All Data In One Place
Data is aggregated from almost any source in one place for analysis, eliminating siloed information. Increase your confidence in data integrity and trial quality with a single solution for data review, safety monitoring, site performance oversight, advanced analytics, and study level insights.
Fast Data Insights
Near real-time data refreshes allow for ongoing signal detection and course correction. Track issues from identification through remediation. Prevent delays with database locks.
Detect Powers Risk-Based Approaches
Centralized monitoring capabilities supplement costly, site-based monitoring and allow a more targeted approach, creating more efficient monitoring strategies.
You can more easily adopt remote, risk-based and decentralized clinical trial activities with Medidata Detect.
Modular Capabilities that Scale with You
Medidata Detect was developed to support a wide range of users and activities, including data managers, medical monitors, central monitors, CRAs, and clinical project managers.
Detect is the only solution which supports multiple activities with modules – choose only the relevant analyses you need.
Key Features of Medidata Detect
Patient Data Surveillance
Patient Data Surveillance includes Data Reviewer and Patient Profiles applications, and gives data managers and medical monitors the ability to automate data review and assess intuitive, in-depth patient safety reviews across all data sources.
Key Risk Indicators
Key Risk Indicators (KRIs) gives monitors and other clinical team members the ability to track site and country performance and compliance.
Medidata Detect provides 10 industry-standard KRIs out of the box, and additional custom KRIs can be created in a matter of minutes from Rave EDC or external datasets.
Quality Tolerance Limits
Medidata Detect supports the identification of systemic and protocol-level issues with Quality Tolerance Limits (QTLs). QTLs are simple to configure and allow project leads to monitor for systemic risks to trial outcomes and patient safety.
Medidata Detect supports risk-based quality management operating models to improve data quality and patient safety while also reducing cost. Detect is unified with Medidata Risk Management and Rave CTMS to improve cross-functional collaboration with closed loop issue management.
Centralized Statistical Monitoring
Centralized Statistical Monitoring (CSM) is the analytic engine of Medidata Detect, allowing central monitors to run targeted analysis for data veracity and site compliance, as well as uncover unexpected data associations or trends using machine learning. CSM analyzes all data, from Rave EDC and other data sources, and is unified with Rave CTMS for closed loop issue management.
Rave Trial Assurance
Using this managed service, sponsors and CROs are provided actionable insights that they can take immediate action on to prevent trial delays. Medidata experts perform assessment of protocols, deliver findings, and propose actions that may be taken, all powered by Detect and delivered by our dedicated professional services team.
Medidata Risk Management
Medidata Risk Management gives sponsors and CROs the visibility and power to manage oversight and risk during study planning and through trial conduct. It is an integrated digital solution which identifies critical-to-quality (CtQ) factors, associated risks, mitigation strategies, and monitors for those trial risks through key risk indicators (KRIs) and quality tolerance limits (QTLs).
Rave CTMS is a unified digital solution that improves the speed, efficiency, and collaboration for the oversight of your studies, countries, and sites through automation and workflow management.
Central Monitoring is the Key to Data Integrity in DCTs
Medidata’s recent blog outlines the challenges of operationalizing DCTs and how new clinical monitoring strategies can solve these challenges. Centralized monitoring strategies built on a unified data platform can improve DCT execution, helping aggregate and analyze data in real time, and provide insights to a variety of functional teams independent of physical location.
Improving Clinical Trial Oversight with Central Monitoring
Read this white paper to learn how proper adoption of risk-based quality management strategies, including centralized monitoring, can shorten trial timelines, reduce overall costs, and improve trial outcomes.
Moderna Chooses Medidata Detect to Ensure Data Integrity and Patient Safety
Moderna used Medidata Detect to help them with early risk identification and proactive mitigation planning to advance its fast paced pivotal vaccine trial.