Cogtest

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Services

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.


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

Quality Assurance

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.


Training

“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.


Trial Data

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.

  1. Rivastigmine Augmentation of Novel Antipsychotics (APDs) in Schizophrenia - Presented at Davos Schizophrenia meeting, 2004
  2. Lundbeck/Solvay/Wyeth Buprefenox - PR Newswire release, 2004
  3. Janssen Risperidone Consta - Presentation at Davos Schizophrenia meeting, 2004
  4. AstraZeneca Seroquel vs Risperidone in Schizophrenia - Poster presentation at CINP Paris, 2004
  5. Lilly First Episode Study (CPT-IP) - Published by Am J Psych, May 2004
  6. Cognitive Enhancement in Schizophrenia with Alpha7 Agonists
  7. Cognitive Enhancement in Schizophrenia with Inverse Agonist and Competitive Antagonist of the 5HT2A Receptor
  8. Randomized Trial of APDs in Treatment of Naïve First Episode Schizophrenia
  9. Adjunctive Treatment of Schizophrenia and Bipolar Disorder with Glycine, D-cycloserine, L-carnosine
  10. Effects of Nicotinic Agonist on Cognitive Function in Schizophrenia
  11. Effects of Ability on Cognitive Function in First Episode Schizophrenia
  12. Cognitive Effects of Atomoxetine in Schizophrenia