Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions Blog Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues…Certara2023年12月12日
10 Things to Know About eCTD 4.0: Embracing the Future Regulatory Submissions Blog eCTD 4.0について知っておくべき10のこと:今後の規制当局への提出 In this blog post, we explore the top 10 things you need to know about…Certara2023年10月17日
Accelerating a drug launch with value communication technology and an integrated workflow Case Study バリューコミュニケーション技術および統合されたワークフローを用いて医薬品の上市を加速 With early approvals for a targeted cancer drug in Brazil and Argentina, this global pharmaceutical…Jim Gallagher2023年10月2日
Medical Device | Medtronic Demonstrating the economic value of minimally invasive spinal surgery on the iPad Case Study 医療機器 | Medtronic社、iPadを活用して低侵襲脊椎手術の経済的価値を実証 This case study describes the use of a web-based platform to demonstrate the value of…Jim Gallagher2023年10月2日
Using customer engagement technology to create value communication tools for ABILIFY MAINTENA® (aripiprazole) Case Study Using customer engagement technology to create value communication tools for ABILIFY MAINTENA® (aripiprazole) Otsuka identified several weaknesses in their existing workflow for developing value communication tools. In particular,…Jim Gallagher2023年10月2日
Maximizing Reusability for Drug Submissions to Different Health Authorities Blog Maximizing Reusability for Drug Submissions to Different Health Authorities Many drug developers have products that they want to submit for marketing approval in several…Certara2023年9月21日
How A Biotech Startup Company Increased Flexibility and Efficiency by Switching to Phoenix Hosted Case Study バイオテクノロジー新興企業がPhoenix Hostedに切り替えて柔軟性と効率を高めた方法 Discover how a biotech startup enhanced flexibility and efficiency by adopting Phoenix Hosted, streamlining workflows…Danielle Pillsbury2023年9月8日
ICER’s Unsupported Price Increase Report: Unfit for Policymaking White Paper ICER’s Unsupported Price Increase Report: Unfit for Policymaking Since 2019, the Institute for Clinical and Economic Review (ICER) has published an annual Unsupported…Danielle Pillsbury2023年7月25日
Interlaboratory Variability in the Madin–Darby Canine Kidney Cell Proteome Publication Interlaboratory Variability in the Madin–Darby Canine Kidney Cell Proteome Madin–Darby canine kidney (MDCK) cells are widely used to study epithelial cell functionality. Their low…Danielle Pillsbury2023年6月28日
What’s New for SEND 2023 On-Demand Webinar What’s New for SEND 2023 This webinar will focus on several changes to the CDISC SEND standard that became active…Danielle Pillsbury2023年6月12日