Improve Your Approach to Sharing Clinical Trial Data

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 … Continued

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 … Continued

Certara’s ClinGenuity Named a “Cool Vendor” in Gartner’s 2015 Life Sciences Report

PRINCETON, NJ – Apr. 30, 2015 – Certara®, the global biosimulation technology-enabled drug development consultancy, today announced that its ClinGenuity company has been named a “Cool Vendor” in Gartner, Inc.’s 2015 Life Sciences report1. ClinGenuity was acquired by Synchrogenix, Certara’s regulatory writing company, in January 2015. “We are delighted that Gartner has recognized us,” said … Continued

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. … Continued

Synchrogenix & CISCRP Partner to Help Biopharm Companies Meet Clinical Data Transparency Mandates

The Center for Information and Study on Clinical Research Participation (CISCRP) and Synchrogenix, Certara’s regulatory writing consultancy, are collaborating to develop lay summaries of clinical trials for the general public PRINCETON, NJ – April 23, 2015 – Certara®, the global biosimulation technology-enabled drug development consultancy and the nonprofit Center for Information and Study of Clinical … Continued

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 … Continued

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