How does a clinical development plan help drug programs?
How important is a clinical development plan? Your biotechnology start-up’s candidate asset has an intriguing…
Certara2024年7月26日
What is a Scientific & Medical Publications Professional?
Would your drug development program benefit from partnering with experts in scientific and medical communications…
Certara2024年7月19日
Pinnacle 21 Enterprise Analytics: Case Studies from the Field
In this blog, we look at some examples of how Pinnacle 21 Enterprise Analytics (P21E)…
Certara2024年7月15日
Drug Discovery Platform Unlocks Scientific Data Access
The D360 desktop application supports drug discovery workflows, data access, and early development research data…
Certara2024年7月12日
3 Things You Should Know About ADaM Standards
Learn the key aspects of ADaM standards, including the difference between SDTM and ADaM and…
Certara2024年7月4日
Categorizing & Managing Risks in Aggregate Safety Reports
Categorizing Risks From a sponsor’s first authorization to conduct a clinical drug trial in any…
Certara2024年6月28日
Future Clinical Study Design: CDISC, FHIR, OMOP, or Hybrid Model?
2024年6月27日 Advances in technology and changes to the regulatory environment have resulted in…
Certara2024年6月27日
Generative AI Tools for Regulatory Writing
規制関連文書の作成は、医薬品開発プロセスの重要な要素です。Regulatory writers must understand…
Certara2024年6月20日
ICH M12 Guidelines & Your Drug-Drug Interaction Package
We have provided an overview of the key changes to the ICH M12 drug-drug interaction…
Certara2024年6月19日
Using Real World Data in Clinical Trial Submissions
We explore challenges & best practice recommendations to help you implement submission standards when using…
Certara2024年6月17日
