Process

Click here to view the Cogtest Service “From Protocol to Publication.”

We provide our clients with an excellent service and partnership from the planning of the study to the  publishing of the results. The following describes the stages of Cogtest’s potential contribution to your study and our team’s activities through the life of a study:

Planning Stage

• Specialist advice on protocol design and selection of the appropriate cognitive tests

• Advice on selection of research sites

• Planning of statistical analysis

• Assignments of a dedicated project manager and project team

Before the Trial

• Customization of cognitive tests for unique cultures and environments, including the language translation and cultural validation of the test battery

• Assistance in the selection, purchase, and configuration of new computer hardware or evaluation and reconfiguration of existing hardware

• Customization of input screens, output formats, blinding of examiners, stratification and randomization procedures, and unique reporting, as well as application of data summarization requirements

• Preparation of study manuals, the training program (videos/DVD-Rom/Investigator Meeting), and procedure documentation

• Assembly, loading, software-burn-in, and shipping to sites of the Cogtest Console

• Site set-up of hardware and training of local personnel

• Security assessments and procedures implemented for data integrity, confidentiality, and compliance with 21CFR Part 11.

• Training and certification of examiners (at Investigator Meetings and individual sites)

During the Trial

• 24/7 technical support and troubleshooting

• Customized data verification processes, detailed audit trails documenting data integrity at each stage of processing facilitated by immediate online data capture and daily monitoring by a neuropsychologist

• Continuous online monitoring available to CRAs via near real time web reports  

• Automated data backup, off-site secure storage, and archival maintenance of trial data

• Customized data cleaning/screening processes, automated range and consistency checks

• Comprehensive quality assurance processes implemented with ongoing site monitoring

At the End of the Trial

• Statistical Analysis, Report-writing, and Presentation of Results

• Customized reporting, data summarization, data analysis, preparation of reports, FDA filings, IRB reports

• Presentation of findings at scientific meetings

• Preparation of data for presentation and publication