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Protocol Review |
We work with you to select the tests and protocol most appropriate to the needs of your trial. |
Cambridge Cognition can provide a review of a clinical study protocol from a very early draft to near completed form. The review culminates in a report that details our recommendation of the cognitive measures that would best serve your scientific and commercial objectives.
The list of key measures for your protocol is supported in the review report with references to relevant literature and supplemented by:
- Investigation into the scientific rationale for those measures in terms of their ability to detect effect, drawing on preclinical and clinical evidence (evidence of the utility of the tests in studies of neuroimaging, the target compound or its class, or the target clinical area).
- An overview of the psychometric properties of the measures.
- The optimal research method for study/trial implementation, focussing on battery design, visit schedule and other methodological features.
- A description of the outcome variables that should be extracted from the various tests, possible composites or algorithms, statistical techniques, and any other issues that may impinge on the final analysis.
- Implementation factors which are relevant to the successful use of these tests, such as suggested validation or training procedures, or issues relating to the provision of these tests (such as cost, service delivery, quality assurance).
- The rationale for the proposed tests with respect to regulatory acceptance.
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Services 
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