24 October 2023
Launch of automated quality assurance for clinical trials
Cambridge Cognition (AIM: COG), which develops and markets digital solutions to assess brain health, is pleased to announce the launch today of AQUA, the Company’s automated quality assurance solution for central nervous system (“CNS”) clinical trials that is powered by the Company’s innovative Winterlight speech and language platform. This is the first such solution available in the market. The Company has already secured one customer for AQUA.
Cambridge Cognition believes there is considerable potential for AQUA. Based on independent market research commissioned by the Company, the market opportunity for automated quality assurance for CNS clinical trials measuring cognition alone is estimated to be £16m per annum within five years. Cambridge Cognition also believes there could be further opportunities for use of the technology in other therapeutic areas and in healthcare applications.
Quality assurance is an essential requirement for clinical trials as set out under ‘Good Clinical Practice’ guidelines. CNS clinical trials, for example for Alzheimer’s disease or Schizophrenia, can rely on a clinician asking a patient questions and manually scoring the answer. In later stage, large clinical trials, quality assurance is critical as poor quality clinical consultations could change the result of the trial. Currently, expert clinicians usually listen to a proportion of patient consultations for later stage clinical trials to identify and report mistakes. Those reviews can be slow and expensive.
AQUA was developed by the Company using advanced voice technology developed by Winterlight to conduct quality assurance more quickly, economically and accurately. AQUA can be used to assess every single patient consultation and provide a structured report to the pharmaceutical company within hours, not days or weeks. The product is available in nine languages and is available for several widely-used CNS clinical instruments and adaptable for almost all. AQUA can also confirm that it is the same patient in each subsequent consultation.
With AQUA, pharmaceutical companies can be more confident that the data from their clinical trials is accurate. They can address problems, such as off-script questioning or inaccurate scoring, with a particular clinical trial site within hours. Then subsequently, they have reports from every single patient consultation as evidence of appropriate quality adherence for regulators for a new drug application.
The Company has conducted its own trial comparing non-experts using AQUA with expert clinicians, showing that there was a high degree of correlation. Using these results, the Company has already secured a lead customer for AQUA and the solution will be used for the first time in a phase II clinical trial for Alzheimer’s disease that is starting later in 2023.
Commenting, Matthew Stork, Chief Executive Officer of Cambridge Cognition, said:
“AQUA is an entirely new solution for the clinical trials market providing a level of quality assurance that was not possible before, from a cost or time perspective, with traditional reviews by medical experts. We acquired Winterlight Labs intending to commercialise their innovative verbal clinical assessments and, by launching AQUA, we have achieved the first of our product goals. We are also really pleased to have already won a client for AQUA as we expect this will provide us with an excellent case study for future sales.”