Driving CNS Trial Success with 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.
Unified Solutions for CNS Assessments
Medidata and Cogstate are pioneering a comprehensive, unified CNS solution, offering a full suite of science-backed, technology-enabled services that set a new standard for CNS trial success.
Deep Integration Drives CNS Trial Success
What truly sets this partnership apart is the deep system integration achieved by Medidata and Cogstate, uniting technical, operational, and scientific expertise to power end-to-end CNS trial support. The unified solution streamlines CNS trial operations by reducing patient & site burden, improving data quality, and minimizing rater errors.
Automated Access Gating to Medidata eCOA
Raters receive automatic access to Medidata eCOA forms once they complete Cogstate’s rater training & certification program, ensuring that only qualified users can access the appropriate instruments.
Automated Central Monitoring Workflow
Leverage Medidata’s integration with Cogstate’s central monitoring platform to streamline data review. Cogstate central reviewers are automatically queued and notified as patient data is submitted in the Medidata’s eCOA platform, enabling raters to receive timely feedback and implement corrective actions without delay.
Single Device Access to ClinRO and PerfO
Centralize assessment access by leveraging a single device for both ClinRO and PerfRO, simplifying the process for raters and patients while enhancing data reliability and offering a comprehensive view of patient cognitive performance.
Medidata App – Built and Designed With Raters in Mind
By integrating Cogstate’s scientific expertise, the Medidata App has been optimized to prioritize raters’ needs and address common errors, ensuring greater ease and accuracy in administering eCOA assessments.
The built-in navigation bar and progress indicators allow raters to easily move between sections of the form, skip ahead, revisit incomplete areas, and finalize forms before submission with greater efficiency.
Raters can annotate forms using their preferred method – whether typing, handwriting, or capturing images of external notes – offering flexibility and convenience in how they input assessment notes.
Automatic audio recording with smart transcription and section/pause markers allows for retrospective review, ensuring quality control and rater consistency, ultimately improving data accuracy and reliability in CNS trials.
Embedded, real-time clinical guidance/ help text ensures that raters administer assessments with accuracy and consistency, simplifying complex assessments for more reliable outcomes.
Integrated within the Medidata Platform, data captured in the Medidata App automatically flows into Rave EDC, streamlining data collection, improving data quality, and enhancing operational efficiency.
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.
Cogstate 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 & 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 & 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. Tailored feedback on administration techniques is sent directly to raters and score changes are proposed where needed, empowering raters to enhance their performance and maintain data integrity throughout the trials.
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.
Learn More
eCOA 101: ClinRO vs PerfO
What’s the difference between Clinician-Reported Outcomes (ClinRO) and Performance Outcomes (PerfO)? Read our blog to gain foundational knowledge of eCOA and discover how leveraging this technology can enhance clinical trial conduct while providing a patient- and site-centric experience.
Patient Cloud Expert Series
Join Aryana Hosseinkhani, VP of Product Marketing, Patient Cloud ad AI, as she hosts an engaging interview series featuring Medidata’s leading eCOA experts.