临床元数据存储库应该做些什么？
2024 年 4 月 4 日 As the clinical research industry moves towards more efficient and automated processes, clinical…
Simona Colucci2024 年 4 月 4 日
是什么促使对 SEND 数据集服务的需求增加？
Gain an understanding of CDISC SEND dataset creation challenges impacting the biopharma industry, and how…
Jim Gallagher2024 年 3 月 29 日
Everything You Need to Know About CRFs in Clinical Trials
Read about the basics of CRFs and eCRF design, why annotated CRFs should be standardized…
Simona Colucci2024 年 3 月 26 日
Everything You Need to Know About SDTM
Find out all you need to know about CDISC SDTM, from the SDTM implementation guide…
Simona Colucci2024 年 3 月 12 日
Best Practices for a Successful eCTD Submission
Learn common pitfalls that pharmaceutical sponsors encounter during the regulatory eCTD submission procedure and best…
Rob Connelly2024 年 3 月 5 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…
Danielle Pillsbury2023 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…
Danielle Pillsbury2023 年 9 月 21 日
SEND Dataset Quality Control: Best Practices & Recommendations
In this blog, Senior Product Management Director Peggy Zorn explores best practices & recommendations for…
Certara2023 年 4 月 25 日
New FDA Validator Rules V1.6 Explained
In this blog, we explore what you need to know about the update to the…
Certara2023 年 1 月 12 日
