Medidata
+ Cogstate
Central nervous system (CNS) indications are highly heterogeneous, making clinical trial measurements complex and involving intricate cognitive and behavioral assessments prone to data variability.
To tackle this challenge, Medidata and Cogstate have partnered to offer comprehensive, deeply integrated solutions for CNS trials. These solutions are designed to streamline operations while ensuring the highest standards of endpoint data quality.
A Connected Approach to CNS Trial Execution
Certified Raters
Automated Access Gating
Raters receive automatic access to Medidata eCOA forms after completing Cogstate’s rater training and certification program, ensuring only qualified users administer CNS assessments and reinforcing consistency from the outset.
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Cogstate Data Quality Solutions
Cogstate, an industry leader in cognitive measurement, combines scientific and operational expertise to deliver precise and reliable CNS data capture, ensuring high-quality outcomes at every stage of the clinical trial process.
View CNS eCOA GuideCogstate Scientific Expertise
With a team of CNS experts, Cogstate offers comprehensive guidance on all aspects of cognitive and clinical outcome assessment, ensuring that trial sponsors receive tailored support and insights for precise data capture.
Tailored Rater Training and Certification
Cogstate offers tailored certification pathways designed to match rater experience, featuring eLearnings developed by clinical experts with firsthand knowledge of assessment scales and common rater errors. Their multi-modal training approaches ensure effective learning and retention, empowering raters to deliver high-quality, reliable assessments in clinical trials.
Strategic and Risk-based Central Monitoring
Cogstate’s central monitoring service provides rigorous expert review to ensure the highest reliability of data. By leveraging custom, data-driven algorithms, potential rater errors are quickly identified, and clinical experts perform targeted reviews of test administrations.
Central Rating by Clinical Experts
Remote access to experienced central raters via telehealth ensures data quality, reduces site burden, and offers flexible, patient-centric assessments either on-site or at home.
Scientifically Validated Cogstate PerfO Batteries
Cogstate’s digital cognitive assessments, with a proven record of supporting successful regulatory interactions and approvals, increase sensitivity and specificity in measuring cognitive functions, while fully automated scoring eliminates the need for expert raters. Test data have been used to support successful regulatory interactions and approvals.
