Most Trusted Partner in Life Science

医薬品開発は成功確率が非常に低い一方で、そのプロセスには多大な労力と費用が必要とされます。At Certara, we partner to understand, anticipate and address your critical drug discovery and development risks and decisions using biosimulation and tech-enabled services.

The benefits of biosimulation are significant. A top ten global biopharmaceutical company by R&D spend, estimated that they saved more than half a billion dollars over three years using Certara biosimulation to inform key decisions. Biosimulation can reduce the size of and cost of human trials, the most expensive and time-consuming part of drug development, and in some cases, eliminate certain human trials completely. An analysis published on Applied Clinical Trials Online, to which Certara contributed, estimated that $1 billion was saved in clinical trial costs using biosimulation for a cancer drug due to consistently shorter completion times in the later phase clinical trials.

More than 1,650 customers worldwide chose Certara as their trusted partner for our gold-standard biosimulation software and tech-enabled services. お客様の信頼できるパートナーとして、サイクルタイム短縮、コスト削減、患者さんのアウトカム改善を目指して、医薬品研究開発プロセスにおける重要な意思決定を確信を持って下すサポートを提供します。

さらに、Phoenix™ PK/PDプラットフォームやSimcyp™ PBPK Simulatorソフトウェアプラットフォームは、米国FDAやPMDA、EMAを含む世界17エリアの規制当局に採用されています。

90 percent of new drug approvals by the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Review (CDER) were received by Certara’s customers in 2022, excluding diagnostic agents. バイオシミュレーションソフトウェアと技術主導型サービスを活用するサターラのクライアントは、腫瘍学から希少疾患に至るまで、幅広い治療適応症で新薬をFDAから承認されています。

Link to FDA Novel Drug Approvals for 2022


100+ Novel drugs Informed by the Simcyp Simulator

Developed and updated over the past 20 years via the Simcyp Consortium of leading biopharm companies, the Simcyp Simulator is used by our consulting team to support companies of all sizes and stages of drug development. Used by regulators for drug review, Simcyp was leveraged for the first FDA MIDD PBPK project. The Simcyp Simulator has informed dosing decision for 100+ new drugs and 300+ label claims for oncology, rare, CNS, cardiac, and other therapeutic areas.

View the Simcyp 100 video
100+ Novel drugs Informed by the Simcyp Simulator
Leading the Industry in Drug Discovery and Development with gold-standard software platforms

Leading the Industry in Drug Discovery and Development with gold-standard software platforms

Certara’s quantitative approach to model-informed drug development offers a comprehensive view of the clinical and regulatory possibilities and challenges facing new therapies. 新薬の開発や承認申請においてお客様が直面する可能性と課題をThese insights help us to anticipate and align our technology roadmap with our customers’ needs and priorities. By providing the clearest picture of both opportunities and risks in the development lifecycle, we remove doubt and inspire confidence at key milestones during the process.




Unmatched Experience and Expertise
Bio Pic KarenYeo
Karen Rowland Yeo, PhD Seinor Vice President, Client &Regulatory Strategy

Simcypにおいて2002年からin vivoにおけるヒト薬物動態を予測するin vitroデータの外挿プロジェクトを率いてきました。また、Simcyp Simulatorに実装されるPBPKモデル構築プロジェクトのメンバーも務めていました。特に、PBPKモデリングとDDI予測といったテーマを中心に研究に取り組んでいます。

Bio Pic JulieBullock
Julie Bullock, PharmD Senior Vice President, Global Head of Clinical Pharmacology & Translational Medicine


Bio Pic PietGraaf
Piet van der Graaf, PharmD, PhD Senior Vice President, Quantitative Systems Pharmacology

製薬業界(SanofiおよびPfizer)において20 年以上の経験があります。QSPプロジェクトに重要な技術と経験をもたらし、サターラの戦略的な開発に貢献しています。また、CPT のEditor-in-Chiefでもあります。

Bio Pic FranBrown 1
Fran Brown, PhD Senior Vice President, Integrated Drug Development



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