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
Quantitative Systems Pharmacology (QSP) Modeling for Immunotherapy-induced Cytokine Release Syndrome
Quantitative Systems Pharmacology (QSP) Modeling for Immunotherapy-induced Cytokine Release Syndrome
Cytokine Release Syndrome Cytokine release syndrome (CRS) is an inflammatory immune reaction that clinically manifests…
Certara2024年8月20日
Automation in clinical trials: Why it’s essential for success
Many companies in the life sciences industry are slow to adopt new technologies. This is…
Certara2024年8月19日
Subject Exposure in Aggregate Safety Reports & Common Issues
All new and existing drugs should be safe, effective, and efficacious for the treated populations.…
Certara2024年8月16日
