Why cancer drug programs need human mass balance studies
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
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?
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
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?
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
With nine FDA-approved drugs today, 100+ in clinical development and several hundred in the preclinical…
Certara2024年9月12日
How has the Inflation Reduction Act Impacted the Biosimilars Market?
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
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
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
Nonalcoholic fatty liver disease (NAFLD) is a condition wherein the liver stores excess fat. Nonalcoholic…
Certara2024年8月23日
