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Streamline your clinical trials with automated metadata management Blog Post

When it comes to efficient clinical study build, content is king. Most importantly: metadata content. Metadata is the building blocks of your study. It’s the forms, terminologies and datasets you…

Regulatory requirements for annotated CRFs made easy Blog Post

aCRFs are a mandatory requirement of the FDA, and therefore a key submission deliverable for any clinical trial. Creating quality annotated case report forms (aCRFs) takes time and attention to…

Resmetirom: A pioneering NASH clinical program Blog Post

Nonalcoholic fatty liver disease (NAFLD) is a condition wherein the liver stores excess fat. Nonalcoholic steatohepatitis (NASH) is one type of NAFLD. Individuals with obesity and type 2 diabetes appear…

Certara to Participate in Upcoming Investor Conferences Blog Post

RADNOR, Pa. — 2024 年 8 月 21 日 — Certara, Inc. （纳斯达克股票代码：CERT), a global leader in model-informed drug development, today announced that Company management will participate in the following investor conferences:…

EU HTA Solutions Page

Certara 全球市场准入专家服务：应对欧盟新 HTA 法规，准备及时、高质量 JCA 材料提交。

Quantitative Systems Pharmacology (QSP) Modeling for Immunotherapy-induced Cytokine Release Syndrome Blog Post

Cytokine Release Syndrome Cytokine release syndrome (CRS) is an inflammatory immune reaction that clinically manifests as fever, headache, joint, and muscle pain in mild cases to hypotension, vascular leakage, and…

Navigating New Terrain: Joint Advice on FDA/EMA Compliance – Aligning with Evolving EU Regulations Blog Post

Navigating New Terrain: The Impact of Evolving EU Regulations on Regulatory Affairs Blog Post

系列文章第 2 部分即将发布，敬请关注：FDA/EMA 合规联合建议 — 应对欧盟法规动态立即注册。    

Automation in clinical trials: Why it’s essential for success Blog Post

生命科学行业的许多公司在采用新技术方面进展缓慢。This is often down to budget restrictions, greater operational burden, and uncertainty with meeting complex regulatory requirements.  …

Subject Exposure in Aggregate Safety Reports & Common Issues Blog Post

All new and existing drugs should be safe, effective, and efficacious for the treated populations. Pharma companies must maintain this benefit-risk balance throughout the drug lifecycle.   The reporting rate of…