Overview

Safety analyses conducted by Safety Scientists necessitate significant financial and operational resources for businesses within the biopharmaceutical, biotech, pharmaceutical, and medical device industries. Regulatory bodies, including the EMA, MHRA, FDA, and other local or health authorities, mandate that these analyses be carried out by medically trained personnel. Consequently, companies such as Roche/Genentech allocate a substantial portion of their annual operational budget to employing these highly specialized and costly professionals.

Additionally, the sheer volume of safety analyses conducted can lead to the underestimation or oversight of crucial findings or objectives. This situation may result in significant data being overlooked and not reported to the relevant regulatory authorities as required. Moreover, the introduction of a tool capable of conducting more sophisticated analytics could uncover areas missed by Safety Scientists. Such a tool would not only augment the work of these scientists by identifying critical insights but also streamline their workflow, allowing them to focus on core activities rather than administrative duties.

The research team plans to conduct a comprehensive survey with a wide-reaching global participant base, utilizing a web application that allows for at-home completion. Participants will engage in established neuropsychological assessments, perform verbal tasks, answer pertinent survey questions, and submit a voice sample. The study's online and anonymous format is designed to enhance its accessibility and diversity, enabling a more effective measurement of the "real-world" impacts of psychedelics on mood and cognition.