Certara helps you achieve late clinical success by providing expert data standardization and validation, advanced statistical programming, and powerful modeling solutions. Our biosimulation platforms ensure optimized dosing strategies and study designs, while our platforms for data standardization and validation ensure compliant, analysis-ready datasets in record time. Trusted globally, Certara empowers teams to deliver submission-ready data efficiently while confidently meeting internal and regulatory requirements.
Confidence in every submission
晚期临床
Ensure your drug's market approval submission
Optimize phase II and III trial designs and dosing regimens
De-risk processes with proven solutions for biosimulation and population PK modeling.
Increase the speed and quality of clinical trial submissions
Achieve standardization, validation, precision and speed for submission-ready data.
Gain greater visibility into your eCTD submissions
Publish and review your regulatory packages with unmatched collaboration and control.
Better phase II and III trials
Ensure your late clinical development achieves success with Certara’s solutions for commercial and regulatory readiness. We empower your team to navigate complex trials with precision and confidence.
- Trial design and dose justification to optimize efficacy and safety.
- Population pharmacokinetics and exposure-response analyses to predict outcomes across diverse patient groups.
- Leverage virtual or synthetic controls for ethical and efficient trial comparisons.
- Conduct thorough drug-drug interaction assessments and biomarker validation to strengthen your data.
- Gain insights with competitive landscape evaluations to position your drug for approval and market success.
Late clinical products
Late clinical services
Late clinical resources
查看全部For a small team that has limited time to compile and double check a submission, GlobalSubmit is a really good platform because it is all integrated, including CROSSCHECK and VALIDATE. 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
Prelude Therapeutics 监管运营副总监
Secure your path to late clinical success
Certara empowers you to navigate the complexities of late stage clinical development with confidence and precision. From optimizing trial designs to ensuring submission-ready data, our proven biosimulation platforms and expert consulting services are trusted globally. Partner with us to achieve regulatory success and speed your path to clinical trial planning and analysis success, regulatory approval and market launch.
Optimize Phase 2 and 3 trial designs with advanced modeling solutions.
Ensure precise data standardization, validation, and regulatory submission compliance.
Deliver submission-ready data efficiently with trusted tools and expertise.
发送查询
探索贯穿药物研发全流程的解决方案
Early clinical solutions
Achieve trial success with Certara’s advanced biosimulation and data platforms, accelerating approvals and empowering data-driven clinical insights.
