サターラ、欧州医薬品庁（EMA）との契約を更新　規制当局の意思決定におけるリアルワールドエビデンス活用のさらなる推進へ

ペンシルベニア州ラドナー2026年6月11日：バイオシミュレーションのグローバルリーダーであるサターラ（Nasdaq：CERT) はCERT), a global leader in model-informed drug development, has been reappointed to a four-year framework service contract with the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC). The project is to advance regulatory decision-making for human medicines via pharmacoepidemiological research, an approach used to study how medications are used in practice and what effects they have in large populations.

“Regulatory agencies increasingly require integrated, decision-grade evidence that connects clinical pharmacology, real-world data, and advanced analytics,” said Adrian McKemey, President, Certara Drug Development Solutions. “Translating evidence into actionable regulatory insight enables agencies like the EMA and the ECDC to make more informed decisions about the optimal use, safety, and effectiveness of medicines across diverse patient populations.”

The scope of the collaboration includes:

• Conducting non-interventional (observational) studies measuring the utilization, safety, and effectiveness of medicinal products (including vaccines) on behalf of the EMA and ECDC,
• Supporting the agencies with robust, principled methodologies - such as target trial emulation, and rigorous bias control,
• Identifying fit-for-purpose secondary data sources or primary data collection, including those sources that inform study feasibility and design, or complement the results of randomised controlled clinical trials.

The contract expands the work Certara is doing with the EMA. This framework contract follows a previous collaboration to advance regulatory decision making and a specific project to assess the real world data landscape for CAR-T cell therapies.

Learn more about Certara’s RWE solutions and broader service offerings in health economics and outcomes research (HEOR) at www.certara.com/evidence-access/real-world-evidence