Early Value Assessment in Gene Therapy Clinical Trial Design Case Study 基因治疗临床试验设计中的早期价值评估 A global biotechnology company engineering precision genetic medicine for rare diseases was in need of…Jim Gallagher2021 年 2 月 12 日
Leveraging Biosimulation to Inform Optimal Use of COVID-19 Vaccines White Paper Leveraging Biosimulation to Inform Optimal Use of COVID-19 Vaccines Danielle Pillsbury2021 年 2 月 3 日
BaseCase Interactive for Medical Affairs Brochure BaseCase Interactive for Medical Affairs Jim Gallagher2021 年 1 月 28 日
Getting Real with RWE Article 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) Case Study Galderma AKLIEF®(曲法罗汀)获得了 FDA 批准 In October 2019, Galderma announced that the U.S. FDA approved AKLIEF® (trifarotene) Cream, 0.005% for the…Certara2020 年 11 月 9 日
The Effects of COVID-19 on Stakeholder Engagement & Value Communication: Preparing for the New Normal White Paper COVID-19 对利益相关者参与和价值传播的影响:准备迎接 New Normal Jim Gallagher2020 年 10 月 28 日
SNDS: Strengths, Limitations and Perspectives for the Largest and Richest Real-World Database in EU On-Demand Webinar 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…Jim Gallagher2020 年 10 月 20 日
New Pinnacle 21 Community Validation Engine: FDA (1907.2) Announcement 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 On-Demand Webinar Exploring Common CDISC ADaM Dataset Conformance Findings What you need to know when validating your CDISC ADAM datasets During the regulatory review…Danielle Pillsbury2020 年 9 月 3 日