Investigator’s Brochure Writing: 5 Tips to Streamline Your SOC Blog Investigator’s Brochure Writing: 5 Tips to Streamline Your SOC Streamline developing a summary of changes for an Investigator’s Brochure, a document that summarizes the…Certara2025 年 2 月 19 日
Streamline Clinical Data Publication Under EMA Policy 0070 Blog Streamline Clinical Data Publication Under EMA Policy 0070 2025 年 2 月 14 日 The European Medicines Agency (EMA) Policy 0070 requires clinical data publication. Its…Certara2025 年 2 月 14 日
Rolling NDA and BLA Submissions: Accelerate Your Review Timeline Blog 滚动提交 NDA 和 BLA:加快审核进度 We look at the growing regulatory trend of rolling NDA and BLA submissions to help…Certara2025 年 2 月 3 日
How to Validate Your Clinical Data Using FDA Validation Rules Blog 如何使用 FDA 验证规则验证临床数据 2025 年 1 月 30 日 For clinical data managers, understanding clinical data validation and applying FDA validation…Certara2025 年 1 月 30 日
Anonymization vs. Redaction of Clinical Trial Data Blog 临床试验数据的匿名化与删减处理的对比分析 2025 年 1 月 17 日 The vernacular for disclosing pharmaceutical clinical trial results to the public may…Certara2025 年 1 月 17 日
CDISC SEND V3.1.1 Updates Nonclinical Drug Developers Need to Know Blog CDISC SEND V3.1.1 更新非临床药物开发人员需要了解的内容 2024 年 12 月 3 日 The Standard for Exchange of Nonclinical Data (SEND) is a standardized, electronic format for…Certara2024 年 12 月 3 日
A Medical Writer’s Guide to Collaborative Authoring Blog 医学撰稿人协作创作指南 Once upon a time, regulatory writing for drug development programs followed a scheduled routine and…Certara2024 年 11 月 22 日
FAQs on Developing EMA Policy 0070 Submissions Blog 制定 EMA 政策0070 提交材料的常见问题解答 In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish…Certara2024 年 11 月 1 日
How To Respond to Health Authority Questions Blog How To Respond to Health Authority Questions Your biotech company has just submitted the marketing application for your first drug product. It’s…Certara2024 年 10 月 25 日
Why You Need an Integrated Development Plan Blog 为什么需要药物综合发展计划? Learn about the Integrated Development Plan for successful drug development & its relation to the…Certara2024 年 10 月 17 日