Catalyzing DMTA Information into Insights Blog Post
Drug discovery is a data-driven research process that requires accurate data capture, ample and reliable data storage, and real-time data analysis. Timely access to all compound data is essential for…
Future Clinical Study Design: CDISC, FHIR, OMOP, or Hybrid Model? Blog Post
Jeffrey Abolafia 2024 年 6 月 27 日 Advances in technology and changes to the regulatory environment have resulted in a change in drug applications, from being comprised of a collection of randomized...
Generative AI Tools for Regulatory Writing Blog Post
监管文件撰写是药物开发过程中的重要组成部分。监管文件撰稿人必须理解科学概念以及最新的法规和指导原则，以编写符合要求的监管文件。作为…
RAPS Sponsored Webcast: Author Clinical Study Reports with Data Privacy & Disclosure in Mind Blog Post
EMA Policy 0070 is a main driver for clinical trial data anonymization. This regulation requires publishing clinical data in regulatory submissions of investigational drugs. This policy aims to increase the…
ICH M12 Guidelines & Your Drug-Drug Interaction Package Blog Post
我们概述了 ICH M12 药物相互作用指南的主要变化，并提供了一个汇总表供快速参考。
Case Study. Enhancing HEOR Global Knowledge Sharing Blog Post
The Global Health Economics and Outcomes Research (HEOR) team of a leading global healthcare company in the pharmaceutical industry was facing significant challenges in distributing extensive training materials across various...Celebrating Certara’s 10th Annual Kraków HTA Symposium Page
Celebrating Certara’s 10th Annual Kraków HTA Symposium With over 100 attendees, the 10th Annual HTA Symposium, held in Kraków May 20-21, brought together a diverse group of stakeholders, including representatives...
How a top 10 pharma fought the rising tide of non-CRF data Blog Post
了解某顶尖药企如何通过 Pinnacle 21 Data Exchange 实现 non-CRF 数据管理自动化、削减资源使用达 80%，并加速提交时间线。
