2025 年 1 月 22 日
关于Certara
Certara 致力于通过生物模拟软件、技术和服务加速药物研发,改变传统的药物研发方式。其客户包括超 2,400 家生物制药公司、学术机构和来自 66 个国家的监管机构。Learn more at www.certara.com.
Certara 联系人:
Sheila Rocchio
[email protected]
媒体联系人:
Alyssa Horowitz
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Home / Announcement / Certara Awarded European Medicines Agency Project to Assess Real-World Data Landscape for CAR-T Cell Therapies
2025 年 1 月 22 日
Radnor, PA – 2025 年 1 月 22 日 – Certara, Inc. (纳斯达克股票代码:CERT), a global leader in model-informed drug development, announced the award of a European Medicines Agency (EMA) project to assess the real-world data (RWD) landscape for Chimeric Antigen Receptor T-cell (CAR-T) therapies.
Challenges in patient recruitment can limit the value of decision-grade evidence obtained from clinical trials. RWD analysis to generate real-world evidence (RWE) can complement and enhance the effectiveness and safety insights derived from clinical trial data to inform regulatory agency submissions. Therefore, available data sources must be reliable, accurate, and comprehensive to meet the high evidentiary standards of these key stakeholders.
“Real-world evidence enriches drug-development decision-making and expedites the entire process in many cases,” said Patrick Smith, President, Certara Drug Development Solutions. “Our team are experts in combining RWD analysis with modeling and simulation technology. This allows us to capitalize on RWE’s vast potential. We are pleased to partner with EMA in this important endeavor.”
The project’s output will help advance the field by
The project award is part of a previously announced four-year, framework service contract Certara signed with the EMA. That contract aimed to advance regulatory decision-making for human medicines with advanced statistical and pharmacoepidemiological research.
Learn more about Certara’s RWE solutions and health economics and outcomes research (HEOR) services at www.certara.com/evidence-access/real-world-evidence.
Certara 致力于通过生物模拟软件、技术和服务加速药物研发,改变传统的药物研发方式。其客户包括超 2,400 家生物制药公司、学术机构和来自 66 个国家的监管机构。Learn more at www.certara.com.
Sheila Rocchio
[email protected]
Alyssa Horowitz
[email protected]