EU CTIS: Europe’s New Clinical Trial Information System
EudraCT has been Europe’s clinical trial database for almost twenty years. But, now it’s the…
Certara2024年5月2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
10 Things to Know About eCTD 4.0: Embracing the Future Regulatory Submissions
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
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
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
Our client was developing a new anti-viral drug for a rare, life-threatening viral infection that…
Danielle Pillsbury2023年4月17日
The eCTD Submission Process: Tips and Tricks for Drug Development Success
Our experts compiled the tips and best practices you need to know for a successful…
Jim Gallagher2022年11月22日
