Introducing RPACT

Where Statistical Innovation Meets Open Source Excellence

Daniel Sabanés Bové

RPACT

April 13, 2026

日本に戻って来れてうれしい! 🇯🇵

Presenting my poster at ISBA conference, Kyoto, 2012

Presenting at PharmaSUG SDE, Tokyo, April 2025

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

Gernot’s book on Group Sequential & Adaptive Designs

Daniel’s book on Statistical Inference

RPACT products: proven ecosystem

Service Level Agreement (SLA) based, custom feature development and license based collaborations:

SLA for rpact for fixed and adaptive clinical trials

New: SLA for crmPack supporting dose escalation trials

Custom feature development for mmrm (just one example of many)

Licensed use of RPACT Cloud as professional graphical user interface

Central dashboard RPACT Connect as one-stop-shop for users

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

See also our new 2026 paper here

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!

You can reach me at daniel@rconis.com

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

Backup Slides

Professional Support: SLA 🤝

  • Service Level Agreement (SLA) with RPACT
  • Flat rate for one year support per company
  • Be part of the “RPACT User Group”
    \rightarrow 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

Daniel Sabanés Bové, Gernot Wassmer, Friedrich Pahlke, Carrie Li