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Category: 博客
Everything You Need to Know About CRFs in Clinical Trials
Whether you want to expand your knowledge of CRFs in clinical trials, or learn the dos and don’ts of CRF design, you’ve come to the right place! Let’s start with the basics. What are case report forms? A case report form (CRF) is a document designed to record all patient information that needs to be … Continued
How Drug Discovery Tools Aid Pharma Decision-Making
Learn how drug discovery tools can help pharmaceutical industry professionals make more informed decisions based on robust data analytics
Why Medical/Regulatory Writing Services Use Style Guides & Lexicons
Learn how style guides and lexicons help medical writers produce clear, consistent, and accurate content for drug development and regulatory submissions.
临床试验软件如何帮助提高研究效率
临床试验在推动医学研究和改善患者治疗效果方面发挥着至关重要的作用。研究的有效性在很大程度上依赖于前沿技术来优化和加速研究的构建和提交流程。 在本博客中，我们将介绍一些革新研究人员设计、管理和分析试验方式的创新软件解决方案。Armed … Continued
关于 SDTM 您需要了解的一切
从 SDTM 实施指南到 SDTM 数据集创建的分步流程，了解有关 CDISC SDTM 的所有信息。
Best Practices for a Successful eCTD Submission
Learn common pitfalls that pharmaceutical sponsors encounter during the regulatory eCTD submission procedure and best practices for addressing them.
如何在 FDA 的监管下开发孤儿药
罕见病是公共卫生领域的优先事项。FDA has launched several programs and a final guidance to address the unmet need for orphan drugs.
靶向放射治疗的剂量优化考量
The acquisitions of targeted radiation therapy companies (TRT) Point Biopharma by Eli Lilly and RayzeBio by Bristol Meyer Squibb have sparked investors’ interest in this therapeutic class. A growing number of companies are now developing TRTs, and GlobalData reports that venture capital deals in the field have grown 550% to $408 million in 2023.1 The … Continued
AIFA 改头换面：意大利飞跃 2024
2024 年 1 月 30 日，意大利药品管理局 （AIFA）进行了一场期待已久的变革。这一直是一个反复讨论的话题，关于合并科学技术咨询委员会（CTS）和价格与补偿委员会（CPR）的讨论也不绝于耳。然而，COVID-19 大流行推迟了这些计划的实施，导致目前的......Continued
