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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…
Clinical Trial Technology & Project Management:
4 Aspects of Cognivia’s Approach
Many sponsors err on the side of reluctance when incorporating new technology in clinical trials. This is because some technologies have the potential to overly burden not…
Q&A: Experts’ Perspectives on the Placebo Response in Clinical Trials
Experts shared their perspectives from real-world trials on both classical and new approaches to manage the placebo response – and some questions arose throughout the discussion.
The Power of Placebo & Trust for Pain Management
A growing body of work has demonstrated that pain perception can be modulated by social, cultural, contextual and interpersonal factors.1,2,3,4 Beyond this, patient trust in their doctor –…
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…
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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