Tag: regulatory

Regulatory Guidelines on Adaptive Designs (FDA, EMA) – Clinical Trial Design and Protocol Development

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Regulatory Guidelines on Adaptive Designs (FDA, EMA) – Clinical Trial Design and Protocol Development “Adaptive Design Regulations as per FDA and EMA Guidelines” Introduction Adaptive designs are a crucial component of clinical studies, allowing for modifications to the trial after it commences without undermining the validity and integrity of the study. Two primary regulatory bodies,…

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Adaptive Trial Designs, Clinical Trial Design and Protocol Development

Regulatory Expectations for RCT Designs – Clinical Trial Design and Protocol Development

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Regulatory Expectations for RCT Designs – Clinical Trial Design and Protocol Development “Guidelines for Designing Randomized Controlled Trials” Introduction Randomized Controlled Trials (RCTs) are fundamental in the clinical research sector, offering a robust method for evaluating the efficacy and safety of new medical interventions. However, the design and execution of these trials must adhere to…

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Clinical Trial Design and Protocol Development, Randomized Controlled Trials (RCTs)