Complex Biologics Page
Certara’s Complex Biologics Services provide advanced support for CAR-T, monoclonal antibodies gene therapies. Trust our expertise to navigate regulatory pathways and enhance success.
French SNDS Data Access and Analysis Page
French SNDS Real World Data Solutions Access Europe’s largest source of real-world data and design studiesIdentify treatment patterns and patient outcomes, uncover unmet needs for rare disease populations, and better...
Payment Pressures in U.S. Specialty: Status quo and outlook for future financing Blog Post
To allow for the optimal positioning of your product, portfolio, or company, it is critical to understand the various forces that shape the US specialty access landscape. Certara’s teams have…
New Pinnacle 21 Community Validation Engine: FDA (1907.2) Blog Post
In August 2020, we released our new Pinnacle 21 validation engine “FDA (1907.2)” for preparing study data for FDA submissions. It includes the validation rules currently used by FDA’s DataFit,…
Certara’s QSP Chronicles: World-renowned Thought Leadership Page
QSP Knowledge BaseWorld-renowned thought leadership A collection of resources to deepen the understanding of QSP impact Quantitative Systems Pharmacology (QSP) is an emerging discipline that has already demonstrated its vast...
Formatting Annotated Case Report Forms (aCRFs): Document properties, bookmarking and table of contents Blog Post
Discover essential tips for formatting annotated CRFs, from dual bookmarking to document properties. Read the 2nd blog post in this series.
Clinical trials of disease stages in COVID 19: complicated and often misinterpreted Blog Post
As of July 28, 2020, 1840 clinical trials were registered globally, with 1001 clinical trials recruiting patients for COVID-19 management.1 Despite this large number, only 30 trials have been published as…
Arvinas Selects Certara’s D360 to Advance Speed and Efficiency of Discovery Research Blog Post
In February 2020, we announced that Certara’s discovery research relationship with Arvinas had expanded to include a greater diversity of small molecule drug discovery projects and data sources. In 2017,...
Submission Leadership Page
Certara’s Regulatory Submissions Services: Expert guidance for IND, NDA, BLA, and MAA submissions, ensuring quality, efficiency, and compliance for biopharmaceutical companies.
Medical Affairs and Scientific Communications Services Page
Our medical affairs consulting services ensure compliance, streamline timelines, and reduce internal burdens.
