Introducing RPACT to Qilu Pharmaceutical

Where Statistical Innovation Meets Open Source Excellence

Friedrich Pahlke

RPACT

April 20, 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; 10 of the top 20 global pharmaceutical companies are our customers
    • 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

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

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

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 as well as training and validation support
    • 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

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