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Embracing Human Complexity in Clinical Research
As clinical trials become more diverse, patient heterogeneity, placebo responses, and inter-site variability become more pronounced, contributing to high rates of failed trials and extended development timelines…
Patient engagement in clinical trials: Why it matters and how to improve it
Recruiting patients for clinical trials is only half of the battle. Retaining those eligible patients over the course of the study to ensure reliable data is another…
Using aggregated site features computed with the MPsQ to allow a better monitoring of sites in clinical trials
Using aggregated site features computed with the MPsQ to allow a better monitoring of sites in clinical trials…
Expectations of Improvement in Clinical Trials: site or patient related?
There are multiple techniques to account for these expectations in studies, including site stafftraining, subject training before the start of the study, and applying an adjustment covariate.
The FDA highlights the tools to enhance the precision of primary analyses in clinical trials.
The FDA released its final guidance regarding the use of covariates to improve the precision of statistical analyses in clinical trials on 26 May 2023. It is…
The Placebo response in drug development Part 6: Allergy & immunology
The placebo response is widely known to compromise evaluation of pain endpoints and has been suggested to contribute to as much as ~2/3 of the measured treatment…
Using Artificial Intelligence-based Methods to Address the Placebo Response in Clinical Trials
Cognivia team members contribute critical elements to a recent paper published in Innovations in Clinical Neuroscience. Cognivia co-authored a…
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