Early Value Assessment in Gene Therapy Clinical Trial Design Case Study Early Value Assessment in Gene Therapy Clinical Trial Design A global biotechnology company engineering precision genetic medicine for rare diseases was in need of…CertaraFebruary 12, 2021
Leveraging Biosimulation to Inform Optimal Use of COVID-19 Vaccines White Paper Leveraging Biosimulation to Inform Optimal Use of COVID-19 Vaccines CertaraFebruary 3, 2021
BaseCase Interactive for Medical Affairs Brochure BaseCase Interactive for Medical Affairs CertaraJanuary 28, 2021
Getting Real with RWE Press Coverage 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) Case Study 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
The Effects of COVID-19 on Stakeholder Engagement & Value Communication: Preparing for the New Normal White Paper The Effects of COVID-19 on Stakeholder Engagement & Value Communication: Preparing for the New Normal CertaraOctober 28, 2020
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…CertaraOctober 20, 2020
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…CertaraSeptember 13, 2020
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…CertaraSeptember 3, 2020