Launch of CTIS-Profile 2+ enables cognitive safety testing of drugs throughout clinical development

Posted on 5 February 2015


The launch of CTIS-Profile 2+ for rapid tablet-based cognitive profiling of patients in Phase II, III and IV clinical trials is the latest in Cambridge Cognition’s range of market leading products on the Cantab Connect cloud platform and importantly means clinical trial professionals can now assess cognitive safety and tolerability for the first time through all phases of clinical development. 

The Clinical Trials Information System Profile 2+ product offers sensitive and reproducible measurement of cognitive impairment in clinical trials from phase II onward.  By replacing existing pencil and paper questionnaires, and their inherent widespread potential for inaccuracies, with cloud computing on iPad tablets, CTIS-Profile 2+ enables trials to proceed with increased reliability and confidence. Clean data capture on the Cantab Connect cloud platform is predicted to have a major impact on multi-centre trial coordination and efficiency.

Chief Scientific Officer Dr Andrew Blackwell, believes offering a full range of cognitive assessment products will have a major impact on new drug development: “Sensitive, intuitive and rapid, CTIS products on Cantab Connect provide clinical trial professionals with the first secure cloud-based platform for cognitive safety and tolerability profiling across the clinical development chain. As well as significantly reducing errors and labor-intensity, touchscreen assessment and electronic data capture will enable better informed decision making and accelerated development of safe and effective therapeutics.”

CTIS Profile 2+ complements the CTIS-Profile product which is designed to enable informed decisions on the cognitive safety of compounds in Phase I, thereby reducing the risk of costly late stage failure. A third product, CTIS-Abuse Liability, provides full compliance with regulatory guidance, which calls for all drug products with the potential for abuse to be assessed.

As with CTIS-Abuse Liability and CTIS-Profile, CTIS-Profile 2+ is designed for GCP-compliant studies. The products all meet FDA regulations for computerized systems used in clinical trials and 21 CFR Part II and comply with the European Clinical Trials Directive 2001/20/EC.

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