现代药物开发是一项团队活动

我们的药物开发团队一直与合作伙伴就 250 多项计划保持良好合作,范围涵盖开发的各个阶段以及从肿瘤学到罕见病的各个治疗领域。

作为您的专职管家,我们的最佳实践、定量和一体化方法可以节省大量时间和成本,同时加快申报和商业成功。从临床药理学到定量药理学,再到监管提交和策略以及市场准入,我们在全球拥有 650 多名知名专家,致力于实现您的目标。与 Certara 一起建立您的药物开发梦之队。

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我们如何为客户提供帮助

Go to Clinical Pharmacology
临床药理学

我们在临床药理学领域的专业知识,对于在药物开发过程中优化安全性和有效性至关重要。药物标签 50% 以上的内容属于临床药理学。

转到临床药理学
Go to Strategy
药物开发与申报策略

通过我们可靠的定量和一体化方法,我们可以帮助您探索日益复杂的药物开发局势,从而最大程度地提高您的成功概率。

转到策略
Go to MBMA
基于模型的荟萃分析 (MBMA)

MBMA 是使用 PK/PD 和统计建模来利用外部临床试验的疗效、耐受性和安全性数据以指导药物开发决策的定量框架。

转到 MBMA
Go to Pharmacometrics
定量药理学

定量药理学使用数学和统计模型来量化药物、疾病和试验信息,以帮助解决关键的药物开发决策。

转到定量药理学

Go to QSP
定量系统药理学 (QSP)

使用 QSP 模型提高研发生产率,该模型可以预测药物如何在空间和时间上改变细胞网络,以及它们如何影响人体病理生理并受其影响。

转到 QSP
Go to QSTS
定量系统安全与毒理学 (QSTS)

QSTS 用于辅助表征药物不良反应。相对于传统的经验终点和基于动物的测试,QSTS将作用方式描述为药物副作用的信号通路和受干扰的机体生物信号传导网络。

转到 QSTS
Go to Simcyp PBPK Modeling
Simcyp 生理药代动力学 (PBPK) 建模

我们可量身定制且领先的 PBPK 建模和模拟 (M&S) 咨询服务能帮助解答一系列问题,而无需依靠临床研究。

转到 Simcyp PBPK 建模
Go to VBE
虚拟生物等效性 (VBE)

我们的 Simcyp 虚拟生物等效性服务帮助实现了第一个,且唯一一个在无需进行临床终点比较研究的情况下获得 FDA 批准的复杂仿制药申请。

转到 VBE

Go to Clinical Pharmacology
临床药理学

我们在临床药理学领域的专业知识,对于在药物开发过程中优化安全性和有效性至关重要。药物标签 50% 以上的内容属于临床药理学。

转到临床药理学
Apply
药物开发与申报策略

通过我们可靠的定量和一体化方法,我们可以帮助您探索日益复杂的药物开发局势,从而最大程度地提高您的成功概率。

Apply
基于模型的荟萃分析 (MBMA)

MBMA 是使用 PK/PD 和统计建模来利用外部临床试验的疗效、耐受性和安全性数据以指导药物开发决策的定量框架。

Register
基于模型的荟萃分析 (MBMA)

MBMA 是使用 PK/PD 和统计建模来利用外部临床试验的疗效、耐受性和安全性数据以指导药物开发决策的定量框架。

Register
为我们的合作伙伴创造实实在在的价值是我们的第一要务

利用我们在建模和模拟、法规科学和市场准入方面的一流能力,我们与您的团队一起指导关键决策,并为您在监管和商业上取得成功做好准备。

敏捷、沟通、质量和信任对于我们合作伙伴关系的成功至关重要。我们携手成为一个一体化且有凝聚力的团队,以便一同预测风险、制定可靠的战略并实现无缝执行。

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我们的专家
Patrick F. Smith President, Integrated Drug Development

Dr. Patrick F. Smith is President of Integrated Drug Development at Certara, where he leads a global team of drug development scientists that creates value for clients across the entire life cycle and ultimately accelerates patient access to medicines. With more than 20 years of drug development experience, Patrick has worked across all phases of drug development with deep expertise in infectious diseases, oncology, and inflammation as well as novel early development program design and applying modeling and simulation to solve critical development problems.

Previously, Patrick was co-founder of d3 Medicine (acquired by Certara in 2016), helping to build a healthcare company that specialized in providing strategic support for complex development programs. Prior to d3 Medicine, Patrick was U.S. Clinical Pharmacology Lead at Roche for more than 5 years, where he worked in various roles of increasing responsibility in clinical pharmacology and translational medicine. He has served as an Associate Professor at the University at Buffalo School of Pharmacy and Roswell Park Cancer Institute in Buffalo, NY. Patrick has published more than 125 peer-reviewed articles in journals, including the New England Journal of Medicine and Lancet. He received his PharmD at the University of California, San Francisco and completed his clinical residency at Duke University Medical Center.

Rik de Greef,理科硕士 一体化药物开发高级副总裁

Rik 的主要经验在于,在整个开发过程中,将基于模型的各个环节与整体临床药理学和临床开发交付成果一体化。他喜欢结合自己的分析能力和创造力来设计有效的药物开发策略,以在适当的时间解决适当的问题。

Andrew Schemick Chief Financial Officer

Mr. Schemick joined Certara as Chief Financial Officer in August 2014. He brings 19 years of financial management experience to the company in a wide range of industries, including software and consulting organizations. Before Certara, Schemick served as Vice President of Financial Planning and Analysis for Haights Cross Communications, a holding company for education and media investments, playing a key role in business transformation, strategy, and financial operations on behalf of private equity investors. Schemick also held Chief Financial Officer roles for two divisions of Kaplan Inc, a leading education company, and has significant experience in both public and private equity backed enterprises. Schemick started his career at Arthur Andersen after graduating with an MBA in accounting from Rutgers University. In addition, he has earned the titles of CPA and CTP.

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