Outcomes Based Agreements On-Demand Webinar

The days of simply determining the market demand for a new drug as a function of price and choosing the revenue or profit optimizing point are gone. In our new environment, an explicit rationale, the “value-based price” has become a...

Three Pathways have emerged in Innovative Access Agreements On-Demand Webinar

The days of simply determining the market demand for a new drug as a function of price and choosing the revenue or profit optimizing point are gone. In our new environment, an explicit rationale, the “value-based price” has become a...

Fundamentals of regulatory writing: the document development process Press Coverage

Regulatory writers lead the development of high-quality regulatory documents by working incollaboration with colleagues across multiple functions. Document development is a multistep processwith the regulatory writer acting as project leader. This article describes each of the stages of theprocess and...

PK/PD Data Programming & Support Page

Discover Certara's PK/PD Data Programming Services to streamline your drug development process. Leverage expert solutions for efficient, high-quality data analysis.

Complex patient profile and narrative template needs Case Study

A global pharmaceutical company came to Certara to generate both patient profile (PPL) and narrative templates for one of its most complex studies. Historically, the Sponsor’s statistical programming team had generated the PPLs as a resource for reviewers to use...