The Certara Blog: Regulatory & Medical Writing

What NASA’s New Horizons has in Common with Regulatory Writing

What NASA’s New Horizons has in Common with Regulatory Writing

Today, NASA’s New Horizons spacecraft will pass by Pluto in the outer solar system after a journey of more than 7.8 million miles (12.5 million kilometers). That is, if everything goes well. After a 6-year journey and a cost of $728 million dollars, mission managers are hoping to avoid a mission ending error caused by […]

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Pediatric Clinical Trials and Tribulations

Pediatric Clinical Trials and Tribulations

Last month, Certara sponsored the 11th Pediatric Clinical Trials conference in Philadelphia. First, I have to say that the content of this conference was among the best I have ever heard. Each speaker added to the dialogue, and the group was able to share and collaborate on how to make meaningful improvements to the field […]

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What You Need to Know about the Precision Medicine Initiative

What You Need to Know about the Precision Medicine Initiative

Last month, I was fortunate to be able to represent Certara at the BIO International Conference in Philadelphia, PA. One of the most exciting sessions that I attended was the Personalized Medicine Plenary with Dr. Francis Collins, the director of the NIH. He discussed how the Precision Medicine Initiative (PMI) will revolutionize the approach to […]

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Do the Right Thing - Ethical Mandates for Clinical Trial Transparency

Do the Right Thing: Ethical Mandates for Clinical Trial Transparency

The history of biomedical research in the United States has long been plagued with ethical problems. Writer Rebecca Skloot details a famous example of this history in her book, “The Immortal Life of Henrietta Lacks.” The non-fiction work recounts the origin of the HeLa cells—derived from the tumor of a Baltimore woman named Henrietta Lacks. […]

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Clinical Data Transparency Mandates Are Reshaping Regulatory Writing

Clinical Data Transparency Mandates Are Reshaping Regulatory Writing

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 this emerging […]

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Strategic Regulatory Writing for Drug Development Success

Strategic Regulatory Writing for Drug Development Success

Happy New Year! The start of a new year brings the promise of new opportunities for growth—both personally and professionally. As the CEO for Synchrogenix, Certara’s regulatory writing consultancy, I’ve been thinking a lot lately about how changes in the regulatory writing landscape will shape the drug development process in 2015. It’s becoming more and more […]

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