臨床メタデータリポジトリに期待すべき役割とは？
2024年4月4日 As the clinical research industry moves towards more efficient and automated processes, clinical…
Certara2024年4月4日
What’s Driving the Increased Demand for SEND Dataset Services?
Gain an understanding of CDISC SEND dataset creation challenges impacting the biopharma industry, and how…
Certara2024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…
Certara2024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…
Certara2024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…
Certara2024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…
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
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
