Life Sciences

Clinical analytics built to stand up to regulatory review

Trusted by all top 20 global life sciences companies in regulated analytics and submission workflows.

Posit enables pharmaceutical teams to produce reproducible, auditable clinical analyses across R and Python. With governed environments and traceable workflows, every result can be rerun, explained, and trusted during regulatory review—supporting faster reporting without compromising regulatory expectations.

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Trusted in regulated clinical and submission workflows

Posit is used by global pharmaceutical organizations to produce submission-ready analyses that can be rerun and explained during regulatory review.

• Proven in FDA, EMA, and other global agency submissions
• Deployed across enterprise R and Python environments in GxP contexts
• Used to standardize workflows from data preparation through final CSR outputs

Explore Posit Workbench for clinical workflows

"There are multiple drivers behind our shift to open-source languages and tools. Data Scientists graduating today expect R and Python to be the backbone of our tools, and our internal experienced data scientists realize and are excited by the new tools and innovations available from this shift."

James Black

Senior Director of Insights Engineering, Roche

"Experiential learning is key to generating the motivation needed to develop our Data Scientists, and RStudio Academy has been a great ally in this journey."

Gabriella Rustici

Director of Data Science Learning and Development, AstraZeneca

"Posit products allow us to deploy R more easily, get started quicker, have confidence that the tools and packages we’re using are accessible and reproducible in the long term, and that we can develop and deploy modern data science products within our company, allowing us to concentrate on better science, faster decision making and getting our medicines to patients more quickly."

Mike Smith

Senior Director of Statistics, Pfizer

Customer Impact

Cut trial reporting time without compromising reproducibility

Within 12 months, Roche reduced SDTM dataset creation time by half—while maintaining reproducible, submission-ready outputs.
• Automated pipelines for SDTM, ADaM, and TLG generation
• Controlled package and environment management to ensure consistent results
• Traceable workflows that support review, reuse, and regulatory confidence

Regulatory Compliance

Meet regulatory expectations with reproducible analytics

Posit supports workflows aligned with GxP, 21 CFR Part 11, and CDISC, helping teams produce analyses that can be rerun, reviewed, and explained during regulatory review.
• Lock package versions and analytical environments to ensure consistent, reproducible results
• Maintain traceability across code, data, and outputs to support audit and inspection review
• Centrally publish controlled, submission-ready artifacts aligned with CDISC standards

Open Source Value

Built for IT, QA, and compliance teams

• Deploy on-premises, in the cloud, or in hybrid architectures
• Integrate with SSO, LDAP, or Active Directory for centralized identity management
• Enforce role-based access controls with audit-ready activity logs
• Support secure and offline deployments, including air-gapped environments

Open analytics without legacy tradeoffs

Standardize on R and Python without sacrificing governance or control. Posit supports the tools scientists already use—while giving organizations the structure needed for regulated work.
• GSK committed to moving 50% of clinical code to R
• Novo Nordisk delivered an R-based NDA submission in under two years

Watch Johnson & Johnson’s open source journey

Build on the community already shaping clinical analytics

Posit supports and contributes to initiatives like Pharmaverse and the R Validation Hub, helping align open-source packages with clinical reporting and submission needs.
This shared foundation reduces duplicated validation effort across sponsors and accelerates adoption of standardized, submission-ready workflows.

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Regulatory confidence, built into the workflow

Posit is designed to support regulated analytics aligned with 21 CFR Part 11, GxP, and global regulatory expectations. Teams generate reproducible results with traceable provenance—without relying on manual controls or one-off validation.

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Pharma Spotlight

Pharma Insights On-Demand

Learn how leading experts tackle real-world challenges in drug development

Explore our growing library of on-demand webinars tailored for pharmaceutical and life sciences professionals. Each session dives into practical applications of R, Python, and open-source tooling in areas like clinical reporting, regulatory submissions, and real-world evidence.