Scales and questionnaires, while important clinical assessment tools, have often not been specifically designed for repeated administrations to detect change, and can be subject to high learning effects and variability due to rater administration. Scoring errors often further increase variability in the data. Robust rater training programs and central monitoring can make the difference between a failed and a successful trial.
The Cogstate Difference: Science + Innovation + Delivery
Cogstate’s senior scientific leadership, all neuropsychologists, have extensive experience and expertise in scales management, rater training and central monitoring for global clinical trials. Our depth of operational expertise and experience, and dynamic relationships among science, operations and technology allows us to deliver exemplary service and novel technologies for the support of rater training and central monitoring programs.
The Cogstate team, supported by advanced systems, provides expert support to raters and investigators, while making it easy for sponsors to monitor progress of start-up activities and in-study testing.
Scale Management and Translations
- Obtaining permissions and licensing agreements, leveraging our established relationships with copyright holders
- Preparation and QC of source documents
- Extensive experience managing translation and linguistic validation for global clinical trials
- Full logistics support: printing, binder assembly, and shipping to sites
Our global network of neuropsychologists design and deploy customized rater training programs for consistent administration and scoring of outcomes measures using a combination of modalities. From self-paced eLearning to in-person instruction and hands-on practice, Cogstate’s expert trainers ensure all raters demonstrate the mastery of administration and scoring of scales.
- Rater pre-qualification
- Training and assessment
- Certification and recertification
- Site monitor (CRA) training
Cogstate and Clinical Ink have partnered to deliver enhanced tablet-based scales assessments for CNS clinical trials. The alliance combines, in a single solution, the scientific and adult learning expertise at Cogstate with the market-leading eSource data capture platform from Clinical Ink.
- Custom edit checks, programmed workflows, and automated scoring that prevents clerical errors and miscalculations.
- Same day access to cleaner source data for central monitoring by Cogstate’s network of local expert advisors (LEADs), with custom flagging algorithms designed by clinical scientists for rapid identification of rater variance.
- Rater training that reaches beyond the investigator meeting and eLearning platform by elegantly incorporating rater guidance into the rating scale instrument for more accurate, standardized administration.
- Growing library of enhanced electronic scales ready for study-specific licensing and protocol customization.
Cogstate develops and executes strategic, risk-based central rater and data monitoring programs to ensure the reliability and validity of clinical measures.
- Data monitoring
- Review of source documents
- Review of recordings
Full Service Solution
- Scientific Consulting
Strategic oversight, research and recommendations on the measurement of cognitive function
- Project Management
Dedicated project managers with scientific backgrounds, facilitating a dynamic and systematic integration of science with the execution of all project tasks
- Data Management
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
Regulatory Compliant and ISO Certified
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, and Cogstate is certified to ISO 9001:2008.