Nonclinical study data submitted to the FDA must align with the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM). The version of data standards for nonclinical studies…
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CDISC stands for the “Clinical Data Interchange Standards Consortium,” and is a global not-for-profit organization that actively develops data standards with the collective knowledge and experience of volunteers within the…
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Clinical trials require a unique approach to public dissemination. Because clinical trials often involve the collection of sensitive information, sharing clinical trial data should always be conducted through formal and…
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It’s never too early to start planning for your NDA Begin assembling your NDA early Understand the relevant statutes and regulatory guidelines that apply to your program Use standardized templates…
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Real-world data (RWD) are data that come from sources other than traditional clinical trials and are becoming increasingly important to today’s healthcare decisions. Historically, drug developers have been limited to…
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Drug applications go through comprehensive reviews of both nonclinical and clinical study data. Historically, these datasets were structured according to the Sponsors’ preferences rather than by standardized criteria, which caused…
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Today, the cost of developing a new drug is higher than ever, driven in large part by improperly designed, untimely, or unnecessary clinical studies. Companies pour money into a development…
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