Certara’s Best of Blogs 2015

A selection of short essays from our blog, written to empower our customers with biosimulation and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing.

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Clinical Data Transparency Mandates Are Reshaping Regulatory Writing

Keith Kleeman

New European and U.S. clinical trial data transparency initiatives — such as EMA Policy 70, which goes into effect this month — are creating additional disclosure compliance requirements for pharma and biotech companies. In this blog post, I’ll discuss the implications of these data transparency initiatives and present how Synchrogenix,powered by ClinGenuity and a Certara company, is addressing […]

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Topics: Regulatory Writing
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