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
Category: 博客
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
为医疗保健产品的市场准入导航：全球价值档案的力量
本博客定义了全球价值档案，并解释了 BaseCase 如何支持创建交互式价值创造工具。
了解发现资产目标产品简介的作用
如果你在一家新成立的生物技术公司工作，你可能会对自己的复合资产感到兴奋，尤其是如果你的开发项目只有一项资产的话。不幸的是，在机会的海洋中遨游可能是一件痛苦多于幸福的事情，尤其是当你的疾病领域有大量投资者活动时。Focusing your excitement is essential! It’s beneficial to … Continued
药物开发人员常见电子通用技术文件问题解答
Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues to evolve as the pharmaceutical industry adapts to changing regulatory standards and innovative technologies. Because of the inevitable changes, the eCTD presents hurdles to regulatory operations professionals, particularly for those who desire to jump in headfirst and get started using … Continued
专家回答您关于制定 EMA 政策的问题 0070 投稿
In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish all clinical studies submitted for regulatory approval. After almost five years of being offline (other than for COVID-19 submissions), the process and new standards that go along with Policy 0070 will likely be new to many sponsors looking to authorize … Continued
