Cogstate announced a new tool to share data from neurological testing. In a 21 CFR Part 11-compliant manner, the company’s DataPoint product shares results from cognitive testing in clinical trials. The company’s technology has been used in more than 30 clinical trials.
The Australian firm touts the following benefits of its system:
•Access to trial-specific CogState testing software, training manual and FAQ.
•Identify and resolve data queries during trial, without altering source data.
•Identify sites having problems with administration of cognitive tests during the study.
•Cognitive database available within hours of last subject, last visit.
•Enhances communication between study sites, sponsor company and CogState to ensure your trial runs smoothly.
•Facilitates integration with electronic data capture (EDC) and clinical trial management system (CTMS) solutions.
•Faster analysis and reporting of cognitive data means faster decision-making.
•Fast access to cognitive safety data aids dose escalation decisions in Phase I trials.
•Secure and auditable trail of data movement means the system is fully compliant with regulatory standards.
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