Getting Real with RWE
By Taren Grom Real-world evidence, important for regulatory decision-making, is beginning to touch all areas…
CertaraNovember 20, 2020
Galderma Achieves FDA Approval of AKLIEF® (trifarotene)
In October 2019, Galderma announced that the U.S. FDA approved AKLIEF® (trifarotene) Cream, 0.005% for the…
CertaraNovember 9, 2020
SNDS: Strengths, Limitations and Perspectives for the Largest and Richest Real-World Database in EU
In this webinar, our experts provided an overview of the SNDS and the key working…
CertaraOctober 20, 2020
New Pinnacle 21 Community Validation Engine: FDA (1907.2)
In August 2020, we released our new Pinnacle 21 validation engine “FDA (1907.2)” for preparing…
CertaraSeptember 13, 2020
Exploring Common CDISC ADaM Dataset Conformance Findings
What you need to know when validating your CDISC ADAM datasets During the regulatory review…
CertaraSeptember 3, 2020
Arvinas Selects Certara’s D360 to Advance Speed and Efficiency of Discovery Research
In February 2020, we announced that Certara’s discovery research relationship with Arvinas had expanded to…
CertaraAugust 21, 2020
Application of PK/PD Modeling and Simulation in Drug Discovery and Development in China
By Yuancheng Chen, Research Associate of Phase 1 Unit, Huashan Hospital, Fudan University, and visiting…
CertaraAugust 7, 2020
