Introducing RPACT
Where Statistical Innovation Meets Open Source Excellence
Daniel Sabanés Bové
RPACT
April 13, 2026
RPACT team: statistics and software engineering 💻
RPACT story: from idea to reality 🚀
- RPACT company was founded in 2017 by Gernot Wassmer and Friedrich Pahlke
- Idea: develop a clinical trial design, simulation and analysis open source R package supported by “crowd funding” from pharmaceutical and CRO companies
- Reality today: some figures to illustrate the success
- Supported by 21 companies
- More than 80 presentations and training courses for
rpact alone since 2018
- 30 vignettes published on rpact.org/vignettes
- 28 releases on CRAN since 2018
- Graphical user interface RPACT Cloud launched in 2024
- New partner Daniel Sabanés Bové joined formally in October 2025
- Since 2024 already collaboration under joint venture RCONIS
- New R package
crmPack for dose escalation trials as new “crowd funded” project
RPACT: Trusted by leading pharmaceutical companies
- Long-term collaborations with global pharmaceutical organizations
![RPACT customers (as of 2025)]()
- Productive use of our tools in research and regulated environments
- Trusted partner for statistical methodology, software, validation, and training
RPACT products: proven ecosystem
Service Level Agreement (SLA) based, custom feature development and license based collaborations:
The rpact Package 📦
- Comprehensive, formally validated R package implementing methodology described in Wassmer and Brannath (2016)
- Enables the design of traditional and confirmatory adaptive group sequential designs
- Provides interim data analysis and simulation including early efficacy stopping and futility analyses
- Enables sample-size reassessment with different strategies
- Enables treatment arm selection in multi-stage multi-arm (MAMS) designs
- Enables subset selection in population enrichment designs
- Provides a comprehensive and reliable sample size calculator
The crmPack Package 📦
- R package for dose escalation trials initially released in 2016, highly flexible and easily extensible for a wide range of designs
- Facilitates trial analyses as well as simulations, allowing for the evaluation of various scenarios and assess the performance of different dose escalation strategies
- Produces plots and summaries, enabling clear and intuitive presentation of trial results
- Paper published in 2019 (link)
- Open source team started collaborating since 2021 (Bayer, Merck, Roche, Cambridge University) (slides)
- SLA-based support and custom feature development started in October 2025 (backfill cohort simulation, currently working on two drug combination designs, next will be validation documentation)
RPACT Cloud ☁️
- Professional graphical user interface based on R/Shiny for
rpact
- Web based usage without local installation on nearly any device
- Provides an easy entry to
rpact in a user friendly and intuitive way and allows to create reports
- Free demo version online available at rpact.cloud
- In 2025, 4 major pharmaceutical companies have licensed RPACT Cloud for internal installation and use on their own servers - fully replacing previous proprietary software
- We support them with extensive documentation covering setup on Posit Connect, configuration, and full qualification/validation
Open source with a long-term commitment
- Open source as a strategic choice, not an experiment
- Clear focus on sustainability, validation, and maintainability
- Reduction of complexity in daily statistical workflows
- Professional governance with service level agreement-backed responsibility
- Continuous evolution driven by real-world user needs
- Synergy with LLM-based coding tools due to open source
Training support – tailored and flexible 🎓
- Transition from proprietary software to R
- incl. introduction to R, R/Shiny design, R functions, Git and GitHub, Good Programming Practices, etc.
- Tool-focused and methodology-focused training tracks
- incl. introduction to
rpact, crmPack, RPACT Cloud, group sequential and adaptive designs, joint modeling of survival and longitudinal data, mixed models for repeated measures, etc.
- Experience from 100+ presentations and training courses, including companies, conferences, and regulatory audiences (FDA)
- Web-based trainings for broad and efficient knowledge transfer
- On-site workshops are possible for interactive and advanced topics
RPACT visits Japan: Let’s connect! 🤝
- I am looking forward to meeting you today and connecting with you!
- I am curious about:
- Your current challenges and experience with R and open source tools in your work
- Your ideas how RPACT could support you and your organization in the future
- I still have free time - let’s arrange a meeting! 😄
- in the morning of 15th April here in Tokyo,
- as well as morning of 16th April in Osaka
- No time this week? No problem, you can book an online meeting slot here!
Executive summary 📝
- Trusted long-term partner for leading pharmaceutical organizations
- Service level agreements for
rpact and crmPack, licenses for RPACT Cloud
- Custom feature and package development
- Coming 2026: RPACT Code AI assistant
- High user adoption through usability-focused packages and graphical user interfaces
- Lean expert organization with clear ownership and long-term commitment, combining methodology, software, and validation expertise
- Proven training expertise with online and on-site formats, tailored to customer needs
RPACT: Where Statistical Innovation Meets Open Source Excellence
Professional Support: SLA 🤝
- Service Level Agreement (SLA) with RPACT
- Flat rate for one year support per company
- Be part of the “RPACT User Group”
yearly customer meetings
- Get technical software support for written support requests
- Get company specific training
- Get company specific software validation documentation for each
rpact release on CRAN
- Get access to the members area at www.rpact.com
- Make an
rpact installation qualification on company servers / containers with your personal testPackage() token and secret
- Determine the direction of
rpact future development activities
- Similar support for
crmPack available, validation documentation coming this year
- Optional support for health authority interactions
- Optional consultation to support specific clinical trials
RCONIS: a joint venture brand 🤝
- RCONIS (Research Consulting and Innovative Solutions) is brand of RPACT, not a formal company
- RCONIS is the brand umbrella for RPACT (rpact.com) and inferential.biostatistics (inferential.bio)
- Statistical consulting and engineering services:
Research Consulting and Innovative Solutions
- Website: rconis.com