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 exemple de mission pour Phases/FDA que confierait NicOx à un tiers

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MessageSujet: exemple de mission pour Phases/FDA que confierait NicOx à un tiers   Lun 22 Juin - 14:36

cela dit UBC est une des entreprises avec qui les employés de NicOx sont le plus connectés



Adaptive trials are an innovative approach to clinical trials that leverage the latest in clinical technologies and science to make pre-determined adaptations to a clinical trial without compromising the statistical validity of the trial.

The major benefits of an adaptive design include: (1) terminating unsuccessful trials early in the process (with ethical benefits for trial participants and financial benefits for the trial sponsor) and (2) increasing the probability of success, as well as the efficiency of clinical development, by learning and adapting during the trial.

Here are several examples of how sponsors can leverage this innovative drug development approach.

Combine a Phase II learning study with a Phase III confirming study, saving the setup time
Make a large simple Phase IIIb or IV trial more efficient than a traditional blinded, placebo-controlled version
Design a combined proof-of-concept and Phase IIa dose-finding trial
Optimize a stand-alone Phase II dose-response trial
Perform an interim analysis in Phase III to ensure the trial is properly powered
Compare the results of multiple endpoints in one trial and adapt to the endpoint that is most relevant
Terminate a trial early for futility
Utilize the Bayesian output of “probability of success” for investor or portfolio management purposes
The key to successful design and implementation of adaptive trials is scientific expertise and technology. Because the UBC team includes both scientific and technology experts, we can help you design an adaptive solution that is most appropriate for your particular needs.

UBC supports you in the development of a customized, integrated approach to adaptive trials with:

Study design planning and protocol development
Integrating applicable technology platforms including: adaptive algorithms, IVRS, IWRS, trial simulation, supply forecasting, ePRO, and EDC
Logistics and supply management planning
Creating interim DMC reports, including trial data tables
Establishing and managing the study DMC
Centralized rating
Providing medical writing services for regulatory submissions
Valued by both the FDA and the pharmaceutical industry, adaptive designs are heralding a new era of flexible research, while improving the efficiency, speed and quality of drug development with the possibility of dramatically changing the clinical trial landscape.
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