Regulatory Writing Experts: Superman or Clark Kent?

The day starts out slowly. The clinical lead settles into her comfy chair, pushes up her glasses just a bit and gazes at the shimmering computer screen, as the spring breeze sways the branches on the other side of the window. Then, one email (bing)…two emails (bing, bing)… ten, twenty! The beeps roar like a … Continued

Regulatory Writing Experts Can Make You a Lean, Mean Pharma Machine

Getting your body into shape has a lot in common with helping implement regulatory medical writing best practices at a biopharmaceutical organization. Specifically, there are a number of similarities between engaging a regulatory writing consultancy and hiring a physical trainer. Unlike “Hans and Franz” of Saturday Night Live fame, who just want to “Pump YOU … Continued

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

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 … 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

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

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 … Continued

The Highlights in Model-based Drug Development for 2014

As the end of the year draws near, I want to thank all of our customers for letting us be your biosimulation and model based drug development solution provider. We feel honored to be able to play a small, but crucial role in your success in bringing safe and effective drugs to patients. 2014 has … Continued

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