A fully customized turnkey solution
Cogtest’s global team is dedicated to working in partnership with the sponsor to provide the most effective service in line with the requirements of the study.
Our experts provide specialized advice on the design of the study, test selection, and site selection worldwide.
Cogtest trains and certifies investigators and provides ongoing training in a variety of mediums (online, via multimedia, at the investigator meeting, and on-site).
Cogtest provides secure electronic data capture (EDC) and near real time web reporting as well as data management, statistical analysis, and report writing.
Cogtest’s dedicated team of project managers (MDs and PhDs) have previous work experience with major pharmaceutical companies and CROs. The study coordinators and project managers have experience working with major sponsors in multinational trials. They are dedicated to the business and their clients.
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:
Before the Trial
During the Trial
At the End of the Trial
Cogtest has an in-house quality management system ensuring that all our cognitive tests are designed, standardized, translated, validated, documented, data managed, and reported in compliance with protocol, SOPs, European GAMP-04 guidelines, HIPAA guidelines, and FDA 21 CFR part 11 regulatory requirements.
The Quality Assurance Department follows an independent, planned, systemic and ongoing quality assessment program covering quality management and organizational performance to ensure excellence in delivery to our clients.
The Quality Assurance Department performs regular and recurrent internal audits including: In-process (initiation, process and reporting stage of projects), Retrospective, and System Audits. These audits develop long term goals in an effort to prevent problems, anticipate challenges and provide continuous quality and improvements to our service.
“Good training leads to good results.” Cogtest provides training at the Investigator Meeting (IM) or online, depending on the sponsor’s choice. Training is also given to site personnel during the site set-up where a Cogtest representative will “sign-off” or certify all personnel involved in the use and maintenance of the console. Separate training is provided to CRAs either at the IM or through an online e-learning module.
The Cogtest Console is user friendly and can be operated by most site personnel. It does not have to be administered by a psychologist.
Cogtest has a large normative and patient database and has shown pharmacosensitivity to various compounds, e.g. scopolamine, antidepressants, antipsychotics, and cognitive enhancers.
There are over 80 publications of individual tests in the Cogtest Library from worldwide data along with fMRI validation of some of the tests used in the library.