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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Characterization of exposure versus response of edoxaban in patients undergoing total hip replacement surgery.

Edoxaban is an oral direct factor Xa inhibitor approved for the prevention of venous thromboembolism (VTE) in Japan. The objectives of this analysis were to characterise the population pharmacokinetics (PK) of edoxaban and the relationships between edoxaban exposure and clinical outcomes in a phase IIb study of surgical patients following total hip replacement (THR). A […]

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Improve Your Approach to Sharing Clinical Trial Data

Kim Green

Transparency and disclosure of clinical trial data has been a hot topic, growing in prominence and strategic discussions over the past few years. Disclosing clinical trial information and creating transparency around clinical trial results are key steps toward increasing trust between the public and the industry. Increased transparency regarding data about ongoing research could spur new products or therapeutic approaches and potentially avoid unnecessary trials.

From ClinicalTrials.gov to EudraCT, and from redacted clinical trial reports to lay summaries, there are a number of platforms and opportunities from which to share data with the public. Pharmaceutical, biotech, and academic researchers need to be conscious of the regulations, stay ahead of the game, and put the most efficient practices in place to keep up with the evolving disclosure landscape. In this blog post, I’ll discuss why the best practices for meeting these regulations involves leveraging the unique skill set and knowledge of regulatory writing groups.

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Topics: Regulatory Writing
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