Why cancer drug programs need human mass balance studies Blog 为什么癌症药物项目需要人体物质平衡研究 Historically, drug programs for oncology and other rapidly fatal diseases didn’t include mass balance studies…Certara2024 年 9 月 23 日
All You Need to Know About Non-CRF Data in Clinical Trials Blog 临床试验中 Non-CRF 数据的全面解析 We look at the role of non-CRF data in clinical trials, and best practices for…Certara2024 年 9 月 16 日
Why Should You Use LOINC Codes For SDTM? 博客 Why Should You Use LOINC Codes For SDTM? 2024 年 9 月 16 日 In this blog, we take a detailed look at LOINC Codes and…Certara2024 年 9 月 16 日
The SDTM Mapping Process Simplified Blog The SDTM Mapping Process Simplified SDTM mapping can be one of the most challenging programming problems in a clinical trial…Certara2024 年 9 月 16 日
What Are SDTM Supplemental Qualifiers? 博客 What Are SDTM Supplemental Qualifiers? We touched on the SDTM supplemental qualifier in the SDTM mapping process simplified. In this…Certara2024 年 9 月 16 日
4 Ways That Mechanistic Modeling Accelerates Bispecific (and Multispecific) Antibody Drug Development Blog 4 Ways That Mechanistic Modeling Accelerates Bispecific (and Multispecific) Antibody Drug Development With nine FDA-approved drugs today, 100+ in clinical development and several hundred in the preclinical…Certara2024 年 9 月 12 日
《降低通胀法案》对生物类似药市场有何影响? 博客 《降低通胀法案》对生物类似药市场有何影响? The Inflation Reduction Act (IRA), one of the key legislative achievements the Biden-Harris administration, aims…Certara2024 年 8 月 27 日
Streamline your clinical trials with automated metadata management Blog Streamline your clinical trials with automated metadata management When it comes to efficient clinical study build, content is king. Most importantly: metadata content.…Certara2024 年 8 月 26 日
Regulatory requirements for annotated CRFs made easy Blog Regulatory requirements for annotated CRFs made easy aCRFs are a mandatory requirement of the FDA, and therefore a key submission deliverable for…Certara2024 年 8 月 26 日
Resmetirom: A pioneering NASH clinical program Blog Resmetirom: A pioneering NASH clinical program Nonalcoholic fatty liver disease (NAFLD) is a condition wherein the liver stores excess fat. Nonalcoholic…Certara2024 年 8 月 23 日