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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…
Global Reach, Local Understanding: Cognivia’s Participant Questionnaire Validated in Over 50 Languages for Comprehensive Clinical Trials
For high quality clinical trial data, the voice of the participant (i.e. patient and/or caregiver) must be captured in the language that they can understand. In this…
7 responsibilities for life science service providers to ensure ICH-GCP compliance
For life science service or technology providers engaged in clinical research, it’s imperative to ensure compliance with international standards. Even though the ultimate responsibility for compliance lies with…
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 next frontier in clinical research & patient management
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Cognivia helps clinical trials reduce data variability, empower decision-making, and accelerate the launch of new therapies.
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