Medidata AI Integrated Evidence is a comprehensive software solution that leverages historical data from over 33,000 cross-sponsor clinical trials and 10 million patient volunteers, combined with real-world data. This powerful tool provides clinical development leaders with crucial insights and evidence to enhance the probability of trial success, offering a unique advantage in the rapidly evolving landscape of clinical development.

Key Features

Regulatory-grade Clinical Trial Data Provides high-quality data for informed decision-making

• Contains traditional clinical trial endpoints and complete covariate information
• Offers patient-level data in common domains with over 100 harmonized variables

Synthetic Control Arm Pioneering approach for creating external controls

• Builds cohorts using patient data from previous clinical trials
• Applies statistical methods for dynamic matching to experimental trial patients

Integrated Real World Data Enhances evidence-generation capabilities

• Links clinical trial data with real-world data at the patient level
• Bridges evidence gaps for more confident decision-making

Benefits

Increased Trial Success Probability Enhances overall clinical development outcomes

• Enables better trial design and more scientifically-rigorous Synthetic Control Arms
• Supports stronger drug positioning for commercialization

Evidence-based Decision Making Facilitates informed choices in clinical development

• Provides powerful modeling capabilities
• Offers deep regulatory, clinical, and commercial expertise