About RPACT
RPACT® (R Programming for Adaptive Clinical Trials) was founded in May 2017 by Prof. Dr. Gernot Wassmer and Dr. Friedrich Pahlke. Our mission is to provide innovative, high-quality software solutions, training, and consultancy services for confirmatory adaptive clinical trial designs using the R statistical software.
Our goal is to foster collaboration within the pharmaceutical industry, focusing on the efficient and reliable application of adaptive clinical trials through open-source R software. By offering expert guidance and cutting-edge tools, we help companies optimize their clinical trial processes, reduce costs, and ensure regulatory compliance.
For pharmaceutical companies and contract research organizations (CROs), we provide:
- Expert Consultancy: Adaptive design methodology, R/Shiny programming, and R package development.
- Customized Training: Tailored courses to empower teams with practical skills in statistical design and software use.
- Software Solutions: Development, validation, and maintenance of GxP-compliant statistical software.
Our business model is centered on offering professional services while maintaining a strong commitment to open-source software principles.
CEOs and Founders
Gernot Wassmer, PhD
Gernot Wassmer has been an adjunct Professor for Biostatistics at the Institute of Medical Statistics, University of Cologne, Germany. He received his PhD 1993 at the University of Munich, Germany, and was a Research Fellow at the Institute of Statistics, University of Munich, at the Institute for Epidemiology, GSF Neuherberg, and at the Institute of Medical Statistics, University of Cologne, Germany.
His major research interest is in the field of statistical procedures for group sequential and adaptive plans in clinical trials. He has been a member in independent data monitoring committees for international, multi-center trials on different therapeutic fields and also serves as a consultant for the pharmaceutical industry. In 2017, he was a guest professor at the Medical University of Vienna, Austria.
Gernot Wassmer is author of many methodological papers in this area. Thanks to his many years of experience in clinical research, he brings theoretical and statistical know-how to the company. His tasks are as follows:
- Development of the statistical methods of the software
- Methodological advice on the planning, implementation, and analysis of clinical trials
- Planning and implementation of training courses
- Answering methodical customer questions about the software
- Documentation of the statistical methods and theory used
- Implementation of statistical algorithms
Gernot Wassmer’s list of publications can be viewed here.
Friedrich Pahlke, PhD
Friedrich Pahlke is a computer scientist with a PhD from the University of Lübeck, Germany. His academic research focused on the statistical analysis of genetic data using R. Since 2008, Friedrich has been working as a full-time freelance software developer and consultant, specializing in statistical computing and clinical trial software.
His passion for open-source solutions and decades of hands-on experience in software engineering make him a driving force behind RPACT’s innovative tools, including the validated R package rpact, the RPACT Cloud, and RPACT Connect.
Key Responsibilities:
- Software requirements analysis and design.
- Development, validation, and maintenance of GxP-compliant software.
- Creation and enhancement of user interfaces.
- Development of RPACT Cloud and RPACT Connect.
- Customer support and process automation.
His research interests include the development of advanced randomization algorithms for clinical trials, such as covariate and response-adaptive methods.
Friedrich Pahlke’s list of publications can be viewed here