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Biometrics and Data Science Services

Transform your study into meaningful insight

Driving precision and efficiency throughout development

Certara’s Biometrics and Data Science Services apply data rigor to improve the odds of drug development success. We leverage all available information, including our own curated clinical outcomes database (CODEX) and drug interaction database (DIDB) to inform study design, make trials more adaptive and efficient, and interpret results to tailor future development strategies.

13,500
clinical studies curated and available to explore in the CODEX database
80
reduction in manual effort when creating define.xml using Pinnacle 21
100
publications and NDA/BLA packages analyzed monthly in the Drug Interaction Database (DIDB)
PK/PD Data Programming & Support
Bridge the gap between your analysis plans and modeling requirements.
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Biostatistics and Statistical Programming
Advanced biostatistics consulting and CDISC-compliant SDTM & ADaM datasets
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Drug Interaction Solutions Consulting Services
Certara’s Drug Interaction Consulting Services empower pharmaceutical researchers and regulatory scientists to decode complex drug interactions. By leveraging the scientist-curated
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What sets us apart

Proven expertise

We are trusted by top pharma companies to deliver regulatory-ready datasets and accelerate timelines. In fact, we are leading the charge for better data collection standards.

Seamless workflows

End-to-end support for data integration, analysis, and validation.

Regulatory confidence

Built-in compliance with global standards like CDISC, and global clinical standards CDASH, STDM, and ADaM thereby aligning with FDA recommendations.

Power every phase with better data collection

Data standardization and validation as a culture within your organization is an intellectual asset. Certara services help you get your team working with best data collection practices.

  • Align datasets with CDISC standards to minimize delays.
  • Integrate nonclinical and clinical data for flawless submissions.
  • Build robust, automated workflows for lasting efficiency gains.

Explore data science insights

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On-Demand Webinar

Higher Standards: Achieving Cleaner Data, Faster, from Protocol to Submission

Join our webinar to explore best practices for harnessing the power of standards, without a heavy lift.
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Video

Pinnacle 21 Enterprise Data Exchange | How to get more compliant vendor data, delivered faster!

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Case Study

Adopting CDISC Standards: Our Journey With CDISC

In this case study, we explore our 23-year partnership with CDISC and we look at a number of collaborative projects.
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Ready to transform your data workflows?

Send us an inquiry on how our services can bring insight and quality to your decisions and submissions.

Leverage industry-leading tools like Pinnacle 21 and DIDB®.

Ensure your datasets are submission-ready every time.

Save time, reduce costs, and achieve your regulatory milestones.

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Solutions for Data Scientists

Solutions for data scientists

Enhance workflows with data standardization and compliance tools built to support you at every step.

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Software innovations

Explore platforms like Pinnacle 21 to simplify and streamline your submissions.

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Convert your source data to STDM format

Make earlier safety & efficacy decisions with rapid trial insights

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