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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To better understand CDISC standards, the requirements surrounding CDISC, and how Nuventra can assist your team in complying with CDISC standards, we have created a two-part blog on what you need…
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To better understand Pharmacokinetic (PK) CDISC standards, the requirements surrounding PK CDISC standards, and how Nuventra can assist your team in complying with CDISC standards, we have created a two-part blog on…
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