临床开发计划如何帮助药物项目？
How important is a clinical development plan? Your biotechnology start-up’s candidate asset has an intriguing…
Certara2024 年 7 月 26 日
什么是科学与医学出版专业人士？
Would your drug development program benefit from partnering with experts in scientific and medical communications…
Certara2024 年 7 月 19 日
Generative AI Tools for Regulatory Writing
监管文件撰写是药物开发过程中的重要组成部分。Regulatory writers must understand…
Certara2024 年 6 月 20 日
Dreaming big with standardization in clinical trial design – one biopharma’s metadata automation journey
This case study explores how one biopharma gets deeper insights & more informed decision making…
Certara2024 年 5 月 13 日
Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates
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
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
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
Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues…
Certara2023 年 12 月 12 日
