Both the FDA and EMA have made statements that support the concept of using real world evidence (RWE) for regulatory decision-making. Historical control arms represent a way to take a…
Pinnacle 21 臨床データ管理と自動化一式を用いて、臨床試験の申請データのスピードと質を向上。
Alzheimer’s disease (AD) is one of the most common forms of neurodegenerative dementia in the United States. In fact, the Alzheimer’s Association predicts that by the year 2050, the number…
In this webinar, Michael Beers reviews FDA, PMDA, and CDISC guidance for preparing vaccine studies for regulatory submissions.
The era of gene therapy may have started a couple of decades ago, but approvals of agents based on the platform have been relatively recent. In 2017, Spark Therapeutics, Inc….
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