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Covariate Adjustment in Randomized Clinical Trials Based on Latest FDA Guidance: Application to composite covariates
In May 2023, the FDA has unveiled its definitive guidance titled “Adjusting for Covariates in Randomized Clinical Trials (RCT) for Drugs and Biological Products”. This guidance marks a pivotal moment…
Development of end-to-end data management to improve lead times
Technical poster submitted to the BIO-IT World and presented on May 3rd 2022. The implementation of an optimized data management pipeline might require multiple underlying technical solutions that should integrate perfectly one with another. It can be complicated to find its own path among off-the-shelf…
Using the Placebell Covariate to Manage Placebo Response in Clinical Trials
Erica Smith, Chief Business Officer at Cognivia, introducing Placebell©™a tool that can be used to manage the placebo response in clinical trials.
Patients are people: a new take on patient-centricity
If you ask a dozen people in the pharmaceutical / biotech industry what the term “patient-centricity” means, you’re likely to get a dozen different answers. These may include…
Predicting the placebo response in quality of life, sleep and fatigue
While significant placebo responses rates are often noted in clinical trials for indications like pain and depression, this issue can plague drug development in any therapeutic area…
Leveraging historical data to optimize the number of covariates and their explained variance in the analysis of randomized clinical trials
The amount of data collected from patients involved in clinical trials is continuously growing. All baseline patient characteristics…
Should strong placebo responders be excluded from clinical trials?
Using Predictive Modeling to understand the impact on assay sensitivity The placebo response is a heavily studied and historically challenging phenomenon for drug developers. Strong placebo effect…
The next frontier in clinical research & patient management
We’re proud to be leading the charge into the next era of drug development.
Cognivia helps clinical trials reduce data variability, empower decision-making, and accelerate the launch of new therapies.
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