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.
成功事例
Proven success from molecule to market
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Customer success: from molecule to market
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1 / 6薬事規制Cut QC time of regulatory submissions from hours to minutes「CROSSCHECKおよびVALIDATEを含む、すべてが統合されているので、申請のコンパイルや再確認の時間が限られている小規模なチームにとって、GlobalSubmitは本当に素晴らしいプラットフォームです。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創薬Shorten the design-make-test-analyze cycle"D360のおかげで、年間でデータ解析に費やす時間を数百時間も削減することができました。D360 は当社の研究を支える重要な基盤となっています。サターラの専門家チームは、粘り強く、柔軟な対応力を持っていて、常に解決策を提案してくれます。That’s what has made our relationship so successful." Dr. Keith Hornberger, Director of Chemistry, Arvinas
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3 / 6前臨床Drive efficiency across the PK workflow"クラウドベースのソリューションを導入することで、社内のITインフラは不要になります。ITサポートやバリデーション対応、コンピュータシステムのコンプライアンス対応といったサポートも必要なくなり、そうした業務の多くをクラウド提供側が担ってくれるため、私たちはより科学そのものに集中できるようになります。”Jocelyn Webb, Associate Director, Global Pharmacokinetics, Charles River Laboratories
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4 / 6早期臨床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後期臨床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マーケットアクセス＆商業化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
薬事規制
1/7
Cut QC time of regulatory submissions from hours to minutes
「CROSSCHECKおよびVALIDATEを含む、すべてが統合されているので、申請のコンパイルや再確認の時間が限られている小規模なチームにとって、GlobalSubmitは本当に素晴らしいプラットフォームです。提出書類がコンプライアンスに準拠しているか生成時点で確認でき、バリデーション済みの書類を生成できるので、もう別のツールは必要ありません。」
Jessica Pung, MS, RAC, Associate Director of Regulatory Operations, Prelude Therapeutics
Jessica Pung, MS, RAC, Associate Director of Regulatory Operations, Prelude Therapeutics
創薬
2/7
Shorten the design-make-test-analyze cycle
D360は、データ解析に要する時間を年間数百時間単位で削減します。D360 は当社の研究を支える重要な基盤となっています。サターラの専門家チームは、粘り強く、柔軟な対応力を持っていて、常に解決策を提案してくれます。我々は成功に繋がる強固なパートナーシップを築くことができました。Dr. Keith Hornberger, Director of Chemistry, Arvinas
前臨床
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, Associate Director, Global Pharmacokinetics, Charles River Laboratories
早期臨床
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
後期臨床
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
マーケットアクセス＆商業化
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
Transforming drug discovery and development together
100
rare disease treatments to market
380
complex biologics programs since 2020
10
上位30社の顧客では、平均10年以上の取引実績
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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Partner with the experts trusted by industry leaders
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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