Sensitive, Reliable and Designed for Clinical Research
Cogstate has developed computerized cognitive tests to dramatically increase the sensitivity and specificity of the measurement of human cognitive processes. Cogstate’s tests are rapid and reliable, and most importantly, have demonstrated sensitivity to subtle drug related changes in cognition. They have been designed, developed and validated to withstand the numerous operational challenges of conducting clinical trials, such as testing patient groups with unique characteristics, working with sites in countries or cultures with limited experience with cognitive testing and protocol schedules where there is often limited time available for assessment.
Cogstate tests have consistently demonstrated sensitivity to both the facilitatory effects of cognitive enhancers and to the negative effects of sedative drugs in healthy humans, as well as sensitivity to the effects of drugs used to treat dementia in Alzheimer’s disease and cognitive impairment in schizophrenia, depression and ADHD. The scientific rationale and support for the validity, reliability and sensitivity to drug effects in clinical trials has been detailed in hundreds of publications.
Full Service Solution: Science, Innovation and Delivery
- Scientific Consulting
Custom batteries with expert input based on your objectives, study design and population
- Training and Certification
Remote, study-specific site training and certification program ensures higher quality and lower inter-rater variability
- Project Management
Dedicated project managers with science backgrounds to efficiently drive all study activities from kick-off to final report delivery
- Data Management and Review
Secure online portal, DataPoint®, enables efficient data collection and storage for ongoing review of data quality by our expert data management team
- Statistical Analysis
Our statisticians and cognitive experts customize analysis plans with careful consideration of the study objectives, design and execution
- Regulatory Support
Full support from the development of regulatory submissions that involve cognition to preparation and attendance at meetings with regulatory authorities
- Attendance at meetings relevant to regulatory submissions.
Time, Cost and Quality: The Benefits of Computerized
Cogstate tests can be rapidly set-up across all sites in a matter of weeks. The tests are the briefest available and do not require expert neuropsychologist raters–simplifying and standardizing test administration. Our algorithms automate outcome measures and data is rapidly available for review via our secure web-based portal for faster, more informed decision-making.
Regulatory Compliant and ISO Certified
The Cogstate® system meets all relevant regulatory requirements for security and integrity of data in clinical trials, including 21 CFR Part 11. The support procedures meet GCP guidelines, and Cogstate is certified to ISO 9001:2008.