Software offers real-time cognitive data monitoring.
Press Release Summary:
Internet-based DataPoint enables pharmaceutical companies to access, monitor, and review data from international multi-center clinical trials in real-time at central, secure, web-based location. Data can be sorted and viewed by subject, assessment time point, test date, and test time. Program interfaces with cognitive testing software, creating electronic, auditable trail of secure data movement from first cognitive assessment to database lock, ensuring compliance with FDA 21 CFR Part 11.
Original Press Release:
CogState Launches the World's First Real-time Cognitive Data Monitoring System
SYDNEY, Australia, Oct. 19 // -- Key Points:
o CogState expands product offering to its core market by launching CogState DataPoint
o DataPoint is the world's first real-time cognitive data monitoring system
o DataPoint has been proven successful in clinical trials run by some of the world's largest pharmaceutical companies
CogState Ltd announced today that it has officially launched the world's first real-time cognitive data monitoring system called CogState DataPoint. DataPoint is a powerful, internet-based application that enables pharmaceutical companies to access, monitor and review data from international multi-center clinical trials in real-time at a central, secure, web-based location.
DataPoint interfaces directly with CogState's cognitive testing software, creating a fully electronic, auditable trail of secure data movement from the first cognitive assessment to database lock -- ensuring full compliance with the regulatory Food and Drug Administration 21 CFR Part 11.
In trials where the primary endpoint is cognition, the DataPoint technology represents a step towards complete electronic capture, measurement and review of clinical trial data, moving further away from technologically inferior 'paper and pencil' cognitive test measurements.
Data can be sorted and viewed by subject, assessment time point, test date and test time, making searching for specific test data quick and easy. Users are able to confirm that each clinical trial site is testing according to the protocol schedule and verify the status of the testing. Discrepancies in data can be easily recognized and resolved, with a clean dataset available within hours of the final subject's visit. The speed to obtain access of the cognitive data is ideal when the data is required for dose escalation review meetings for early phase volunteer studies.
All study-specific software, manuals can be accessed on DataPoint, meaning that everything that is required to run a trial and upload data is located in one convenient location.
DataPoint has already been used successfully in more than 30 research trials conducted globally by pharmaceutical, biotechnology and research organizations to manage the collection and analysis of cognitive data, which confirms its reliability, user-friendliness and value.
For more information, visit: http://cogstate.com/datapoint/
About CogState
CogState Ltd specializes in the development and commercialization of rapid, computerized tests of cognition (brain function). The tests are sold to pharmaceutical, biotechnology, nutraceutical and functional food companies to quantify the effect of drugs or other interventions on human subjects participating in clinical trials.
CONTACT: Brad O'Connor, Chief Executive Officer, Mob: +61-411-888-347, boconnor@cogstate.com, or Zoe Whyatt, Project Manager, Mob: +1-860-706-7731, zwhyatt@cogstate.com, both of CogState Ltd.
