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 of access to 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. All studies that utilize a CogState ClinicalTrials test battery will have a dedicated DataPoint® website.
Who can access DataPoint® during a trial?
In a single center study, there is one DataPoint site which displays the progress of testing at the study site. Site staff and sponsor staff can view exactly the same webpage.
In a multi-center study, the DataPoint website represents the progress at each study site on separate pages. Therefore, the site staff is only given access to their own site page, while the Sponsor staff can view all site pages.
