Improve the quality and efficiency of CNS clinical trials with expert data quality solutions.
Cogstate’s senior scientific leadership, all neuropsychologists, have extensive experience in rater training and central monitoring for global clinical trials. Synergies between the Cogstate science and operational teams – supported by advanced technology and eCOA systems – provide expert support to raters and investigators and make it easy for sponsors to monitor progress of start-up activities and in-study testing.
Traditional rater training is often redundant and burdensome to sites and inefficient for clinical trial sponsors. As such, Cogstate has created a rater qualification, instruction, and management program that prepares raters to administer scales to the highest standards in the timeliest way possible. Cogstate's unique approach eliminates unnecessary training, leverages customized eLearning curriculum, minimizes rater certification burden, and allows for expedited study start-up.
Training is tailored to each rater’s experience and ensures conformity with the study protocol. Each rater has a customized training curriculum.
Training is informed by a deep understanding of raters’ limitations and error patterns and uses the latest adult learning methodologies.
Training waivers may be granted to raters who have recently certified for the measures or demonstrated recent good performance in a central monitoring program.
Most training programs are entirely remote, saving time and money. This also allows for learning to take place at a comfortable rate.
In addition to rater training, Cogstate develops and executes strategic, risk-based central rater and data monitoring programs to ensure the reliability and validity of clinical measures in your trial. Central Monitoring is the process of identifying rater errors and preventing them from detrimentally impacting the quality of a study. This involves sampling source documentation and audio recordings of assessment sessions to identify and correct deviations from administration and scoring conventions.
eCOA systems allow for digitally capturing study data with pre-set workflows, real-time edit checks and algorithmic flags to improve data accuracy. Cogstate partners with industry leading eCOA providers to deliver enhanced tablet-based scales and web-based eSource solutions, combining a user-friendly interface with a secure and reliable data management platform. Custom edit checks and automated scoring help prevent errors, and same day access to cleaner source data enables risk-based central monitoring by our clinical experts for greater quality assurance.
Strategic oversight, research and recommendations on the measurement of cognitive function.
Dedicated project managers with scientific backgrounds, facilitating a dynamic and systematic integration of science with the execution of all project tasks.
Secure online portal enables efficient data collection and storage for ongoing review of data quality by our expert data management team.
Our statisticians and cognitive experts customize analysis plans with careful consideration of the study objectives, design and execution.
Full support from the development of regulatory submissions that involve cognition to preparation and attendance at meetings with regulatory authorities.
Reach out to our science and operational experts to learn more about how we support clinical trial teams.
Cogstate has developed unique systems to provide sophisticated and secure training and rater tracking (Cogstate Instructor™), as well as data management and monitoring (DataPoint®). Cogstate systems meet all relevant regulatory requirements for security and integrity of data in clinical trials, including 21 CFR Part 11.
The support procedures meet GCP guidelines.
