Complex Biologics Page
サターラ社の複合生物製剤サービスは、CAR-T、モノクローナル抗体、遺伝子治療の先進的なサポートを提供します。薬事規制対応を成功に導くために、当社の専門知識に頼って頂きたいのです。
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 2020年7月28日, 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. 2017年、当社...
Submission Leadership Page
サターラの規制当局申請サービス：IND、NDA、BLA、MAA申請における専門的なガイダンスを提供し、バイオ医薬品企業に対して、品質・効率・コンプライアンスの確保を支援します。
Medical Affairs and Scientific Communications Services Page
当社のメディカルアフェアーズ・コンサルティングサービスは、コンプライアンスの確保、スケジュールの効率化、社内負担の軽減を実現します。
