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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…
Q&A: Developing a Custom e-Questionnaire Data Management Solution for Clinical Trials
Q&A Interview with Gilles Scuttenaire, Senior Software Engineer In a presentation at BIO IT World 2022, Cognivia’s Gilles Scuttenaire, senior Software Engineer, discussed our custom, end-to-end data management…
The placebo problem in pain: does baseline pain variability predict placebo response?
Recent reports have demonstrated a positive correlation between baseline pain variability and improvement in clinical trial patients receiving placebo, suggesting that patients with more highly variable reporting…
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…
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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