Pharma & Life Sciences

Trusted by all top 20 pharma companies for clinical analytics

Build reproducible, auditable clinical analyses and AI-Powered applications in R and Python - with governance and traceability that FDA and EMA review demands.

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Trusted in clinical submissions at all top 20 pharma companies

How Roche cut SDTM creation time in half

Learn how Roche built governed R workflows that reduced SDTM dataset creation time by 50%, accelerating their clinical submission pipeline.

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Clinical workflows backed by the pharma community

Posit collaborates with Roche, GSK, and other industry leaders on Pharmaverse and R Validation Hub that reduce duplicate validation effort across the industry. These shared resources give clinical teams access to submission-ready packages that have been reviewed and tested by peers at other pharma companies.
 

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Regulatory alignment from code to submission

Run clinical analyses in environments aligned with 21 CFR Part 11, GxP, HIPPA and CDISC standards. Posit Package Manager locks package versions for reproducible results, Posit Connect publishes traceable outputs with automated validation, and Posit Workbench maintains audit trails from code to submission.
 

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Move from legacy to open-source R and Python

Transition clinical programming from legacy tools to R and Python without sacrificing the governance, versioning, and reproducibility that regulatory submissions require. Work in the IDE you prefer (RStudio, VS Code, JupyterLab, or Positron) while your compliance team maintains full audit trails. 

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Proven results

Measurable outcomes in clinical analytics

Data science teams at firms like these ship faster, automate more, and give stakeholders direct access to the analysis behind their decisions.

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50% faster SDTM creation

Roche's Insights Engineering team cut SDTM dataset creation time in half by moving clinical programmers from legacy tools to governed R environments on Posit Workbench. 

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R-based NDA accepted by the FDA

Novo Nordisk went from pilot R project to a complete R-based NDA submission accepted by the FDA in under two years, proving that open-source clinical programming meets regulatory expectations. 

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5x faster analysis

A Janssen scientist cut Alzheimer's disease risk marker analysis from 2.5 days to half a day after the team built RSVP, a scalable R infrastructure on AWS using Posit Connect and RStudio. 

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50% of clinical code migrated to R

GSK moved half of their clinical programming from SAS to R, reducing legacy licensing costs and giving their data scientists access to modern open-source tools on governed Posit environments. 

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  • 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

    James Black headshot
  • Posit products enable 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

    mike smith headshot
  • 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

    Gabriella Rustici headshot

Regulatory Compliance

Run clinical analytics in governed environments
Develop, validate, and publish clinical analyses in R and Python with the traceability and reproducibility your regulatory and QA teams require.

  • Built to support 21 CFR Part 11, GxP, and CDISC compliance

    • Lock package versions with Posit Package Manager for consistent, reproducible results across submissions
    • Maintain traceability across code, data, and outputs with comprehensive audit logging
    • Publish controlled, submission-ready artifacts through Posit Connect with version-tracked provenance 
    package manager package versions
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  • Deploy in your infrastructure with enterprise security

    • Deploy on-premises, in your VPC, in cloud, or in hybrid architectures
    • Integrate with SAML, OIDC, LDAP, or Active Directory for single sign-on
    • Enforce role-based access controls with audit-ready logs exportable to your SIEM
    • Support air-gapped and offline deployments for clinical data environments
    • Run on managed Kubernetes or containerized deployments
    pharma validated environment
    See statistical computing environments

  • Complete traceability from first line of code to submission artifact

    • Comprehensive audit trails track user activity, code changes, and environment configurations
    • Git-based version control documents every change with attributable history
    • Environment snapshots in Posit Package Manager enable exact reproduction of any prior analysis
    • Build and schedule publication of  IQ/OQ/PQ documentation
    Connect Audit logs
    Explore Workbench features

How pharma teams build with Posit

Roche

Roche and Genentech are leading a historic shift by moving to an entirely open-source infrastructure for clinical trials to deliver life-saving therapeutics to market faster. This transition represents years of deep innovation in package development and workflow changes, all powered by a robust open-source backbone.
gloved hand holding a petri dish

Janssen

Janssen Pharmaceuticals revolutionized its R&D efficiency by launching RSVP, a high-performance "R Service for Visualization and Processing" built on AWS. This scalable architecture empowers scientists to conduct complex Alzheimer's risk simulations in just a half-day—down from 2.5 days—while providing a unified platform for sharing critical Shiny applications across the global Johnson & Johnson network.
Computer with visualization

Regeneron

Regeneron transformed its internal professional development by replacing slow, manual pairing processes with MAGNETRON, an AI-powered mentor matching platform built on Posit Team. By integrating R, Python, and knowledge graphs, the team achieved a 20X acceleration in processing applications, enabling personalized growth opportunities for over 4,000 employees across the Fortune 500 company.
Regeneron data science team members Regis A. James, Jordan Leao, and Jennifer Michel collaborating on the MAGNETRON AI platform.

CSL

CSL transformed their operations by moving from static spreadsheets to "living" Shiny applications that allow stakeholders to run their own "what-if" simulations. These tools empower leaders to optimize plasma donation centers and improve patient outcomes through real-time, multivariate analysis.
A close-up, high-angle shot of several small glass vials with yellow caps moving through an automated industrial assembly line

Featured resources

Novo Nordisk: Journey to an R-based FDA submission webinar thumbnail
Webinar

Novo Nordisk: Journey to an R-based FDA submission

The leading pharmaceutical company behind life-changing medicines such as Ozempic, joined Posit to share their celebratory milestone in drug development - an NDA submission using open-source tooling.
GSK: From Pilot Projects to Enterprise Adoption webinar thumbnail image
Webinar

GSK: From Pilot Projects to Enterprise Adoption

Posit teamed up with GSK's Data Science Innovation and Engineering team to discuss how GSK, a leading pharmaceutical company, transformed its biostatistics toolkit by embracing R.

See how Posit supports your clinical analytics team

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