Prelude Therapeutics reduces their quality control (QC) process for regulatory submissions from hours to minutes with Certara’s GlobalSubmit eCTD Software Case Study Prelude Therapeutics社は、サターラのGlobalSubmit eCTDソフトウェアを用いて承認申請の品質管理(QC)プロセスを数時間から数分へと短縮 In 2019, Prelude Therapeutics, a small cancer drug discovery company, implemented Certara’s GlobalSubmit submissions management…Certara2021年3月2日
Getting Gene Therapies to Patients Blog 遺伝子治療を患者へ届けるために This blog discusses the challenges that drug developers face in getting patients access to cell…Certara2021年2月16日
Early Value Assessment in Gene Therapy Clinical Trial Design Case Study 遺伝子治療臨床試験デザインにおける早期価値評価 A global biotechnology company engineering precision genetic medicine for rare diseases was in need of…Certara2021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 Certara2021年2月3日
BaseCase Interactive for Medical Affairs Brochure BaseCase Interactive for Medical Affairs Certara2021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 ガルデルマ社、AKLIEF®(トリファロテン)のFDA承認を取得 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 The Effects of COVID-19 on Stakeholder Engagement & Value Communication: Preparing for the New Normal Certara2020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…Certara2020年10月20日