New data from European Medicines Agency (EMA) confirms the tough position EMA is taking in regard to commercially confidential information (CCI). According to the European Medicines Agency’s “EMA Update on Clinical Data Publication” published on 29 January, 2018, 76% of CCI instances were rejected in 2017. Interestingly, the EMA has provided further insight on how … Continued
In August 2017, FDA updated both the Form FDA 356h (Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use) and the Form FDA 1571 (Investigational New Drug Application) to include new data fields. FDA asks that all sponsors begin using these new FDA forms 356h and 1571 immediately; however, it … Continued
A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.
At Certara, we are innovators, dedicated to helping our clients develop new therapies and target unmet medical needs, expand existing therapies to other subpopulations, communicate scientific information in the language of regulatory success and market access, balance risk-benefit profiles, differentiate therapies from the competitive landscape, and unlock millions of dollars in R&D savings.
Modeling and simulation (M&S) of complex systems has primarily advanced vertically in differing scientific domains with a variety of domain-specific approaches and applications. The pharmacology to payer (P2P) concept is a way to connect independent domains to address drug development market failures. As an initial proof of concept, we collaborated with a team of clinical pharmacologists, … Continued
PRINCETON, NJ – Mar. 13, 2018 – Certara today announced the launch of its Quantitative Systems Pharmacology (QSP) Immuno-oncology Simulator Consortium.
Narratives are an essential part of any programs’ story, but often become cumbersome due to the many challenges of narrative writing. A large narrative project is typically divided into several stages, within which each individual function typically works within a certain pre-defined budget, set of tasks, and labor allocation silo: The biostatistics group produces Tables, … Continued
PRINCETON, NJ – Mar. 12, 2018 – Certara today announced that it is partnering with faculty at the UNC Eshelman School of Pharmacy to launch the Model-informed Drug Development (MIDD) Gran Prix at the 2018 American Society for Clinical Pharmacology & Therapeutics (ASCPT) Annual Meeting.
