A top-10 pharma company leveraged Certara’s regulatory writing services to ensure clinical data is published in a timely manner, objective, accurate, and balanced, regardless of the trial outcome.
Tag: Clinical Transparency & Disclosure
A top-10 pharmaceutical company used Certara’s regulatory writing services to become the most transparent company in the industry.
PRINCETON, NJ – Mar. 24, 2016 – Synchrogenix has introduced an artificial intelligence (AI) -enabled solution to meet the data transparency requirements of the clinical and drug development market.
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
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
As most scientists can attest, it’s not always easy to communicate the importance of your work to non-scientists. I personally experienced this when my fiercely intelligent grandmother, a former elementary school teacher, asked to read a copy of my dissertation. When I asked her what she thought of it, I realized that her understanding of … Continued
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
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
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
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