Integrated Evidence
Clinical development breaks down when decisions rely on incomplete or non-comparable data. As therapies grow more complex, regulatory-grade, patient-level evidence becomes essential.
Medidata Integrated Evidence connects historical trial data, real‑world insights, and AI-driven modeling for safer protocols, stronger comparators, and more efficient clinical development.
Regulatory-grade Patient‑level Data
Integrated Evidence draws from one of the industry’s most comprehensive repositories of regulatory-grade clinical trial data. Through the Data Collaboration Program, sponsors and CROs grant governed usage rights to de-identified, patient-level data, enabling secure modeling and benchmarking with full privacy protection.
AI-driven synthetic data generation extends this foundation, supporting advanced modeling while preserving data integrity.
Cross-sponsor Historical Trial Data
Protocol-defined Covariates and Endpoints
Governed Data Collaboration
AI-driven Synthetic Modeling
Where Evidence Changes Outcomes
De-risk Clinical Development
Predict Therapeutic Efficacy
Isolated study data increases development risk. By contrast, benchmarking cross-sponsor, regulatory-grade historical trials reveals how comparable patient populations performed under standard of care and which eligibility criteria drive response.
Protocol modeling identifies patients most likely to benefit and positions programs for regulatory success and label expansion.
Solutions Powered by Integrated Evidence
Advancing Evidence through Collaborative Research
Integrated Evidence is validated through peer-reviewed research and collaboration across oncology and cardiovascular clinical data scientists, empowered by AI.
Findings presented at ASCO, ASH, ICML, and NeurIPS reinforce the scientific rigor behind our commercial solutions.
CAR-T & Immunotherapy
Longitudinal cross-sponsor trial data identifies predictors of severe cytokine release syndrome and CRS/ ICANS in CAR-T therapies, informing safer protocol design.
Cardiovascular
Historical trial data across major adverse cardiovascular events validates identification algorithms and comparative benchmarking under evolving standards of care.
Synthetic Data
Peer-reviewed generative modeling research demonstrates interpretable techniques that preserve subject-level privacy while maintaining clinical trial data structure for simulation.
FAQ
How does Medidata Trial Design help de-risk clinical development?
Medidata Trial Design combines regulatory-grade data from over 38,000 trials and 12 million patients with AI-powered analytics to model trial scenarios and identify high-risk patients. This allows research teams to inform safer, evidence-based protocols and anticipate obstacles before they lead to costly delays or failures.
What makes Medidata’s synthetic data ('Simulants') unique compared to other synthetic datasets?
Unlike generic synthetic data, Simulants are generated from Medidata’s exclusive repository of standardized historical clinical trial data, complete with covariates and endpoints exactly as captured in protocols. This ensures the data retains high fidelity and statistical validity, allowing sponsors to refine protocols and identify early efficacy signals with confidence.
Can Integrated Evidence reduce the need for patient recruitment in control arms?
Yes. Through the Synthetic Control Arm®, sponsors can build external control groups using de-identified patient-level data from prior studies. This is particularly valuable for rare or life-threatening diseases where recruiting a concurrent control group is difficult, allowing for benchmarking without the burden of additional enrollment.
How does Medidata ensure data privacy within its collaborative programs?
Medidata’s Data Collaboration Program operates under strict governance to protect client and patient confidentiality. Additionally, solutions like Simulants use patented algorithms to generate privacy-preserving synthetic data, allowing for safe data sharing and analysis without exposing real patient identities.
Does Medidata offer training for its clients and partners?
Yes. Medidata offers a variety of training options for our clients and partners, including both self-paced and instructor-led courses. To learn more about available courses and to access our resources, please visit the Medidata Global Education and Training section.