PRINCETON, NJ – Feb. 14, 2018 – Certara today announced the launch of version 10 of D360, its data informatics platform for discovery scientists. D360 is a self-service data access, integration and visualization solution used to query diverse cheminformatics and bioinformatics data sources to make informed go/no go research decisions.
With the May, 2018 FDA mandate quickly approaching, conversion of paper IND’s, NDA’s, and DMF’s to eCTD format must happen soon. Here are some tips for a successful eCTD conversion. It is important to note that once an eCTD submission has been made to an application all subsequent submissions to that application must also be … Continued
Dr. Scott Gottlieb, the Commissioner of Food and Drugs, has outlined the steps the US FDA will take to implement the 21st Century Cures Act. In outlining the plan, the Commissioner endorses modeling and simulation approaches to increase the efficiency of drug development. Certara has launched Phoenix® 8.0, the latest version of the innovative PK/PD … Continued
During my years reviewing applications for the US FDA, I encountered a lot of poor planning concerning a drug’s clinical pharmacology program. This poor planning left the company either lacking data to make informed decisions or scrambling at the end of development to address unanswered issues. Early planning is key to regulatory success, not only … Continued
PRINCETON, NJ – Feb. 1, 2018 – Certara today announced that it has acquired BaseCase Management GmbH, a data visualization software as a service (SaaS) company headquartered in Berlin, Germany, with offices in New York.
