Product will serve as a data source for D360, supporting ongoing study monitoring and cross-study analyses ST. LOUIS, MO – April 29, 2014 – Certara®, the leading global technology-enabled drug development and drug safety consultancy, announced today the launch of its Pre-clinical Safety Store (PCSS). A companion product to D360, Certara’s integrated solution for the … Continued
Purchase adds global regulatory writing and submission services to Certara’s drug development consulting expertise ST. LOUIS, MO – April 15, 2014 – Certara™, the leading technology-enabled drug development and drug safety consultancy, announced today that it has acquired specialty contract research organization (CRO) Synchrogenix Information Strategies Inc. Synchrogenix offers regulatory writing and related services to … Continued
When we are engaged in conversations about developing medicines, how often do you hear language thrown around such as “capturing the value,” “fast to the next value inflection point,” or words to this effect? Drug development is a complex and risky business where remuneration for value creation occurs, by analogy, by passing the baton from … Continued
Model-based drug development in oncology is still lagging despite a good momentum in the clinical pharmacology and pharmacometry community in the past few years. The failure rate of late-stage oncology studies is one of the highest across therapeutic areas. The modeling of the relationship between longitudinal tumor size and overall survival has been proposed to … Continued
The motesanib phase III MONET1 study failed to show improvement in overall survival (OS) in non–small cell lung cancer, but a subpopulation of Asian patients had a favorable outcome. We performed exploratory modeling and simulations based on MONET1 data to support further development of motesanib in Asian patients. A model-based estimate of time to tumor … Continued
