The Clinical Trials Information System Adverse Effects (CTIS-AE) product enables fast, sensitive and reproducible measurement of cognitive impairment in Phase I trials. This enables early informed decisions to be made about the cognitive safety of drugs, reducing the risk of costly late-stage failure in clinical development.
The CTIS-Abuse Liability (CTIS-AL) is a computerised patient-report system enabling rapid, accurate and paperless measurement of the abuse potential for investigational drugs in clinical trials. It enables companies to comply with FDA guidance which states that drug products with the potential for abuse should be assessed for liability. CTIS-AL provides a digital solution, with automated administration and data collection, reducing trial workloads and costs and improving data quality. This product will meet the increasing demand for abuse liability studies to assess the addictive qualities of drugs.
Successful drug trials
Cognitive safety assessment at all stages is increasingly regarded as essential to successful drug discovery and development. According to Cambridge Cognition’s Chief Scientific Officer Dr Andrew Blackwell, Cantab Connect is a real revolution in clinical development: “sensitive, intuitive and fast, Cantab Connect provides clinical trial professionals with the first secure cloud-based platform for all aspects of cognitive assessment. As well as significantly reducing errors and the labor-intensity of such work, touchscreen assessment and electronic data capture will accelerate decision making. For the first two products we have focused on areas of particular concern: adverse effects and abuse liability. CTIS-AE is designed to enable early informed decisions in Phase I on the cognitive safety of compounds, reducing the risk of costly late stage failure. Similarly, CTIS-AL will enable compliance with regulatory guidance, which calls for all drug products with the potential for abuse to be assessed.
Both CTIS-AE and CTIS-AE are designed for GCP-compliant studies. The products 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.