Certara partners with top global pharmaceutical companies, emerging biotechs, and regulatory agencies to transform drug development and bring safer and more effective therapies to patients quicker. Our customers rely on Certara’s biosimulation software, regulatory science, and strategic leadership to reduce time, cost, and risk across the drug discovery and development lifecycle.
客户成功案例
Proven success from molecule to market
Trusted by the world’s leading life sciences innovators and regulatory agencies
Some of our valued partners
Customers share the Certara value
Our customer testimonials, from molecule to market
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1 / 6监管审批Cut QC time of regulatory submissions from hours to minutes“对于一个没有什么时间来编制和仔细检查申报文件的小团队来说，GlobalSubmit 是一个非常好的平台，因为它是一体化的，包括“交叉核查”和“验证”。So, you know when you generate the submission that it is compliant, and you don’t need another tool for validation” Jessica Pung, MS, RAC, Associate Director of Regulatory Operations, Prelude Therapeutics
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2 / 6药物发现Shorten the design-make-test-analyze cycle“D360 每年为我们在数据分析方面节省数百小时。这对我们的研究作出了重要贡献。Certara 团队拥有极为丰富的资源，始终坚持不懈地为我们寻找合适的解决方案。That’s what has made our relationship so successful." Dr. Keith Hornberger, 化学总监, Arvinas
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3 / 6临床前Drive efficiency across the PK workflow“基于云的解决方案使公司不再需要 IT 基础设施。无需 IT 支持、验证支持、计算机系统合规支持 — 这些均由供应商承接，使我们得以更专注于科学研究。”Jocelyn Webb, 全球药物代动力学副总监, Charles RiverLaboratories
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4 / 6早期临床How to ensure regulatory compliance for FDA submissions"Certara’s SDTM and ADaM teams were fantastic at helping us through this process to make sure that that final package met FDA requirements. The whole Certara team worked really well together and with us, too,” Christine Gerber, Senior Project Manager at ATHN
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5 / 6晚期临床Model-informed pharmacometrics to accelerate decisions, reduce risk, and strengthen regulatory readiness“Sunvozertinib received accelerated FDA approval for metastatic NSCLC with EGFR exon 20 insertion mutations — a milestone achieved through exceptional collaboration.”Kan Chen, Vice President of Clinical Pharmacology, Dizal (Jiangsu) Pharmaceutical
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6 / 6市场准入与商业Communicate clinical & economic value with confidence"I actually created the apps we’ve made so far by myself. It’s a really easy-to-use system. Using an app vendor would take a lot longer – that process usually took a month and a half to get a draft. I probably got to the same point with BaseCase in about a week and a half." Heidi Waters, Director of Outcomes Management, Otsuka
监管审批
1/7
Cut QC time of regulatory submissions from hours to minutes
“对于一个没有什么时间来编制和仔细检查申报文件的小团队来说，GlobalSubmit 是一个非常好的平台，因为它是一体化的，包括“交叉核查”和“验证”。所以，当您生成符合要求的申报文件时，便无需其他工具来进行验证。”
Jessica Pung, MS, RAC, Associate Director of Regulatory Operations, Prelude Therapeutics
Jessica Pung, MS, RAC, Associate Director of Regulatory Operations, Prelude Therapeutics
药物发现
2/7
Shorten the design-make-test-analyze cycle
“D360 每年为我们节省了数百小时的数据分析时间，这对我们的研究作出了重要贡献。Certara 团队拥有极为丰富的资源，始终坚持不懈地为我们寻找合适的解决方案。这也是我们能够成功达成合作关系的基础。”Dr. Keith Hornberger, 化学总监, Arvinas
临床前
3/7
Drive efficiency across the PK workflow
“A cloud based solution takes away the need for IT infrastructure around a company. No need for IT support, validation support, computer systems compliance support – a lot of those things are taken over by the company which then can alleviate us to focus more on the science.”Jocelyn Webb, 全球药物代动力学副总监, Charles RiverLaboratories
早期临床
4/7
How to ensure regulatory compliance for FDA submissions
“Certara’s SDTM and ADaM teams were fantastic at helping us through this process to make sure that that final package met FDA requirements. The whole Certara team worked really well together and with us, too,” Christine Gerber, Senior Project Manager at ATHN
晚期临床
5/7
Model-informed pharmacometrics to accelerate decisions, reduce risk, and strengthen regulatory readiness
“Sunvozertinib received accelerated FDA approval for metastatic NSCLC with EGFR exon 20 insertion mutations — a milestone achieved through exceptional collaboration.”Kan Chen, Vice President of Clinical Pharmacology, Dizal (Jiangsu) Pharmaceutical
市场准入与商业
6/7
Communicate clinical & economic value with confidence
“I actually created the apps we’ve made so far by myself. It’s a really easy-to-use system. Using an app vendor would take a lot longer – that process usually took a month and a half to get a draft. I probably got to the same point with BaseCase in about a week and a half.” Heidi Waters, Director of Outcomes Management, Otsuka
Certara impact: stories from industry leaders
100
rare disease treatments to market
380
complex biologics programs since 2020
10
年排名前 30 客户的平均合作年限
33,000
scientific publications cite Certara products
Featured success stories
10
clinical pharmacology studies avoided
2
FDA-approved dosing regimens (80 mg QD & 200 mg BID) validated through modeling
3
faster path from Phase I to global regulatory approval
PBPK modeling accelerates Asciminib (Scemblix®) development by reducing clinical studies
Certara’s physiologically-based pharmacokinetic (PBPK) modeling and Simcyp® Simulator helped Novartis streamline the clinical development of Asciminib (Scemblix®), a novel drug targeting the BCR-ABL tyrosine kinase for treating chronic myeloid leukemia (CML).
Using PBPK modeling, a model-informed drug development (MIDD) approach, Certara enabled the prediction of drug-drug interactions, food effects, and dosing in specific populations — eliminating the need for more than 10 clinical pharmacology studies. This innovative approach accelerated regulatory approval, reduced substantial time and cost, and helped patients by bringing this drug to market faster.
Results:
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Regulators approved dosing based on PBPK modeling results
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Over 10 clinical trials were waived – saving significant resources
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The Simcyp Simulator’s ADAM-PBPK model predicted changes in gastric pH would not meaningfully affect Asciminib exposure
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Accelerated development timelines and regulatory approvals
20
Certara experts partnered with Biohaven to advance Nurtec's development
1
EMA approval achieved using PBPK modeling without a Phase I study
25
Publications supporting this work as of July 2024
Fast-tracking innovation: Certara’s model-informed strategy drives Nurtec ODT to approval
Certara partnered with Biohaven to support the development and regulatory approval of Nurtec ODT, the only migraine therapy approved for both acute and preventive treatment. Leveraging PBPK modeling, pharmacometrics, regulatory strategy, and publication support, Certara’s team helped Biohaven shorten development timelines and reduce costs.
Results:
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1 Phase I PK study avoided through modeling, saving significant time and expense
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2 FDA approvals secured (acute and preventive indications)
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Robust publication output: 9 manuscripts published and 16 abstracts/posters delivered
100
studies supported by centralized metadata
1
single source of truth for standards
50
faster study builds and ADaM upgrades
Biogen transforms study metadata nanagement with Certara’s Clinical Metadata Repository
When Biogen shifted their clinical data management in-house in 2019, they faced metadata chaos: spreadsheets everywhere, poor version control, and no scalable content reuse. To solve this, they adopted the CRF Creator module (formerly Formedix ryze) within Pinnacle 21 Enterprise, plus a centralized metadata repository and standards governance.
Results:
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Vast metadata repository now supports reuse across 100+ global studies
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Faster compliance with CDISC standards, with seamless updates
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Smoother ADaM upgrades and study build workflows
More success stories
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From global innovators to emerging biotechs, our customers rely on Certara to navigate complexity and achieve results that make an impact. Explore our solutions across every stage of drug discovery and development, or connect with us to discuss how we can help transform your drug discovery and development programs from molecule to market.
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