system means complete automation of the assessment, scoring, and data management process from a streamlined computer. With the largest selection of tests on the market, batteries can be constructed for Phase I studies in healthy volunteers or Phase II to IV studies involving a broad range of indications.
Cogtest’s integrated console is a state of the art cognitive assessment precision instrument. It is a key feature of the Cogtest
system, delivering increased security and reliability while meeting the changing needs of clinical trials. The console is built to address current regulatory requirements and is compliant with 21CFR11.
The Cogtest console is the experiment launcher and data collection and transmission application, capturing subject, and trial information (similar to an electronic CRF).
The console is customized according to the requirements of each individual trial. A specific battery of tests is assembled, depending on the domains selected. The most appropriate console (desktop or tablet laptop) is selected for the study and customized accordingly.
Data is securely transmitted to Cogtest or the sponsor's servers via an encrypted connection. Access to the console and
the associated test battery is password protected, with access restricted only to authorized clinical trial personnel. The console is designed in collaboration with the sponsor in order to capture the variables of interest and to facilitate integration with other data streams generated in the clinical trial.
Test features increase efficiency and reduce the cost of assessment. For example, the
Cogtest console incorporates dynamic titration, allowing the use of the same tests in Phase I through Phase III. Tests of attention, working memory, and declarative memory include complexity manipulations to modify difficulty across the full spectrum of possible performance. This prevents ceiling and floor effects.
This unique facility also minimizes the total testing time for valid assessments logically terminating the test if assessment results might be invalid. This means participants who might otherwise undergo costly procedures without yielding useful data will be eliminated from the study early.