Strategic Evidence & Value Communication Symposium
Join us on 2021 年 4 月 21 日, 星期三, from12:00 PM – 2:00 PM EDT for Certara’s…
Certara2021 年 3 月 26 日
Prelude Therapeutics reduces their quality control (QC) process for regulatory submissions from hours to minutes with Certara’s GlobalSubmit eCTD Software
In 2019, Prelude Therapeutics, a small cancer drug discovery company, implemented Certara’s GlobalSubmit submissions management…
Certara2021 年 3 月 2 日
Early Value Assessment in Gene Therapy Clinical Trial Design
A global biotechnology company engineering precision genetic medicine for rare diseases was in need of…
Certara2021 年 2 月 12 日
Getting Real with RWE
By Taren Grom Real-world evidence, important for regulatory decision-making, is beginning to touch all areas…
Certara2020 年 11 月 20 日
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…
Certara2020 年 11 月 9 日
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…
Certara2020 年 10 月 20 日
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…
Certara2020 年 9 月 13 日
Exploring Common CDISC ADaM Dataset Conformance Findings
What you need to know when validating your CDISC ADAM datasets During the regulatory review…
Certara2020 年 9 月 3 日
