Dreaming big with standardization in clinical trial design – one biopharma’s metadata automation journey Case Study 实现临床试验设计标准化的伟大梦想 — 一家生物制药公司的元数据自动化之旅 This case study explores how one biopharma gets deeper insights & more informed decision making…Simona Colucci2024 年 5 月 13 日
Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates Blog 对 FDA 新抗体-药物偶联物临床药理指南的思考 In recent years, oncology drug developers have invested in antibody-drug conjugates (ADCs). These targeted therapies…Certara2024 年 5 月 10 日
Why Medical/Regulatory Writing Services Use Style Guides & Lexicons Blog Why Medical/Regulatory Writing Services Use Style Guides & Lexicons Learn how style guides and lexicons help medical writers produce clear, consistent, and accurate content…Certara2024 年 3 月 18 日
Best Practices for a Successful eCTD Submission Blog 成功递交 eCTD 的最佳做法 Learn common pitfalls that pharmaceutical sponsors encounter during the regulatory eCTD submission procedure and best…Certara2024 年 3 月 5 日
Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions Blog 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…Certara2023 年 12 月 12 日
10 Things to Know About eCTD 4.0: Embracing the Future Regulatory Submissions Blog 10 个关于 eCTD 4.0 的须知事项:迎接未来的监管提交 In this blog post, we explore the top 10 things you need to know about…Certara2023 年 10 月 17 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
Leveraging Pharmacokinetic Modeling & Scientific Communications Expertise Advances Sarcoidosis Drug Program Case Study 利用药代动力学建模和科学传播专长推进肉样瘤病药物项目 Certara's support, from dose optimization to medical writing, helps pharmaceutical companies advance their research, make…Danielle Pillsbury2023 年 6 月 1 日
Using Real-World Evidence to Derive an External Control Arm for a Rare Disease Drug Trial Case Study Using Real-World Evidence to Derive an External Control Arm for a Rare Disease Drug Trial Our client was developing a new anti-viral drug for a rare, life-threatening viral infection that…Danielle Pillsbury2023 年 4 月 17 日