Introducing RPACT
Where Statistical Innovation Meets Open Source Excellence
Daniel Sabanés Bové
RPACT
June 24, 2026
Thanks to the Takeda team in Osaka for the warm welcome!
Big thanks to Yohei Takanami, Fumihiro Yamasaki, Naoki Yoshida, Shoichi Fujita, Xiaolin Song and everyone else in Osaka for the great hospitality and the opportunity to present RPACT.
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Dinner in Osaka with Takeda team
Today we want to also share the information with the global Takeda team incl. Europe and US!
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), custom features 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
- Since 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
- 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
- Community leadership in openstatsware and R/Pharma
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 decades of 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