Rave Trial Assurance
Powered by Medidata Detect
Protect Your Trial From Avoidable Risk and Costly Delays
Rave Trial Assurance is a managed service that evaluates the integrity and quality of all clinical and lab data within your trial. This includes a comprehensive analysis, report, and presentation of results.
Built on the powerful data surveillance tool Medidata Detect, Rave Trial Assurance provides proactive risk mitigation for data quality issues that could delay the trial. You’ll gain immediate, actionable insights to rectify data quality issues which could impact study results and future reviews by regulatory authorities.
Benefits of Rave Trial Assurance
Ensure Patient Safety and Improve Business Outcomes
Missed adverse events, data anomalies, and procedural deviations can negatively affect timelines and lead to costly study delays.
Rave Trial Assurance visually unifies all relevant data for each individual patient, making it easier for you to identify inconsistencies within a patient’s history such as missed visits or incomplete diaries.
Scales to Support Any Trial Size or Complexity
Rave Trial Assurance, powered by Medidata Detect, was recently deployed on a pivotal COVID-19 vaccine trial that enrolled over 30,000 participants. Trial Assurance was used in real-time to analyze and monitor multiple data sources for the vast majority of participants, across 98 sites, and over 28 million data points.
Unmatched Technology and Expertise
Rave Trial Assurance helps you maintain accurate and consistent data over the life of your clinical trial.
Aided by automated statistical examination, a team trained by former FDA statistical reviewers performs a comprehensive analysis of the study data and provides you with regular reports and summarized findings.
Mitigate Clinical Trial Risk and Avoid Delays
Rave Trial Assurance minimizes the risk of study failure from errors unrelated to drug efficacy by enhancing data quality through machine learning.
This helps you identify and address anomalies that manual reviews can overlook.
Key Features
Fully Managed Service
With Rave Trial Assurance, no configuration is required, minimizing your down-time and accelerating time to analysis.
Trial Assurance can be live in as little as two weeks, with only one hour of input from your study team. Data refreshes on a continuous basis to check for anomalous data.
Driven by Machine Learning
Medidata Detect standardizes and prioritizes all clinical data, automatically detects anomalies, and analyzes them in the context of the entire study.
Customized Key Risk Indicators (KRIs) provide early indication of clinically significant trends.
Built on a Unified Platform
Data is unified on the Medidata Clinical Cloud® across multiple sources such as Rave EDC, Medidata eCOA, and Rave Safety Gateway.
Data moves from acquisition to analytics within 48 hours. Rave EDC query linkage eliminates duplicate query reconciliation efforts.
Related Solutions
Medidata Detect
Medidata Detect is a powerful real-time anomaly detection tool for centralized monitoring, powered by automated statistical algorithms and machine learning.
This improves your study data quality and ensures patient safety throughout the trial.
Medidata Risk Management
Medidata Risk Management 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).
Medidata Professional Services
Medidata Professional Services paves the way for the new generation of clinical trials that includes trial decentralization, patient-facing solutions, risk-based quality management, automated issue management, synthetic control arm studies, and advanced analytics.
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Protect Your Trial from Avoidable Risk
Trial Assurance is a unique service both in the analysis and the holistic view it provides by contextually comparing
lab and clinical data.
This analysis of the study database often turns up data quality issues not previously identified.
The Power to Proactively Improve Data Quality and Reduce Trial Risk
Medidata Detect is the analytics engine at the center of the Trial Assurance service.
Medidata Detect helps define and manage study risks during trial design and initiation and uncovers unanticipated data anomalies and helps remediate them to prevent study disruption.
Prevent Data Quality Issues that Derail Drug Approvals
See how a Top 25 Global Pharmaceutical Company protected their path to FDA approval with machine learning using Rave Trial Assurance.
Value Realization through Medidata Expertise and Innovation
The Medidata Professional Services team’s expertise and experience, coupled with Medidata’s innovative, state-of-the-art technology and best practices, can significantly accelerate your clinical studies.
