Pre-Clinical

Purpose

We see our mission as bridging preclinical knowledge and expertise within the pharmaceutical industry and academia to provide a forum to collaborate, discuss and advance statistical topics related to Research, Discovery (including efficacy models), Regulatory and Investigative Toxicology/Safety Assessment. We also hope to encourage the development of relevant statistical methodologies and promote the involvement of statisticians in these areas.

Find out more about us and our objectives in our video overview:

Workshops

Workshop 2025, Verona

The Pre-Clinical Special Interest Group (SIG) Workshop 2025 will take place over two half-days on October 7–8 in Verona, Italy, bringing together experts from industry, academia, and regulatory institutions to discuss key challenges and innovations in pre-clinical research.

This year’s workshop focuses on reproducibility, translatability, and methodological advancements in pre-clinical studies, with dedicated sessions on optimal study design, virtual control groups, and statistical tools like SAS and R. The agenda includes invited presentations, interactive round table discussions, and ample opportunities for networking and collaboration, both during structured sessions and informal social events.

The event is designed to foster knowledge exchange, encourage cross-sector dialogue, and support the development of best practices in the evolving landscape of pre-clinical research.

Further details to come soon!

Workshop 2024, Paris

We held our first face-to-face workshop since 2019 in Paris this year. It was wonderful to connect with old and new faces.There was great engagement in the sessions; we all learnt something and had fun too!

Day

Title

Presenter(s)

Application of experimental design in animal research: theory and practice

Simon Bate, GSK

Analysing Pre-clinical experiments

Odile Coudert, Ipsen & Bernard Franq, GSK

Statistics in Toxicology

Philip Jarvis, Novartis & David Lovell, University of London

PSI Introduction to Industry Training (ITIT) Course - 2025/2026

An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.

Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars

Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.

PSI Webinar: Methodology and first results of the iRISE (improving Reproducibility In SciencE) consortium

This 1-hour webinar will be an opportunity to hear about the methodology and first results of the iRISE consortium. iRISE is working towards a better understanding of reproducibility and the interventions that work to improve it. At the end of the presentation there will also be the opportunity to ask questions.

One-day Event: Change Management for Moving to R/Open-Source

This one-day event focuses on the comprehensive management of transitioning to R/Open-Source, addressing the challenges and providing actionable insights. Attendees will participate in sessions covering essential topics such as training best practices, creating strategic plans, making the case to senior management, and managing both statistical and programming aspects of the transition.

PSI Vaccines SIG Webinar: Challenges in Estimating Vaccine Effectiveness Against Progression to Severe Disease

This is a free webinar on Challenges in Estimating Vaccine Effectiveness Against Progression to Severe Disease.

PSI Book Club - The Art of Explanation: How to Communicate with Clarity and Confidence

Develop your non-technical skills by reading The Art of Explanation by Ros Atkins and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply skills from the book in-between sessions.

PSI Training Course: Pediatric Extrapolation

This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding. We will give you an introduction to the pediatric drug development landscape. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges from a statistical perspective.

PSI Career Young Virtual Event (Q3 2025)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

EFSPI/PSI Causal Inference SIG Webinar: Instrumental Variable Methods

The webinar is targeted at statisticians working in the pharmaceutical industry, and the objective is to 1) provide a basic understanding of IV methodology including how it relates to causal inference, and 2) present two inspirational pharma-relevant applications.

PSI Pre-Clinical Workshop - October 2025

The Pre-Clinical Special Interest Group (SIG) Workshop 2025 will take place over two half-days on 7 - 8 October in Verona, Italy, bringing together experts from industry, academia, and regulatory institutions to discuss key challenges and innovations in pre-clinical research.

PSI/EFSPI Vaccines Statistics Workshop

The program will feature insightful sessions led by distinguished invited speakers, alongside a poster session showcasing the latest advancements in the field. Further details will be provided.

PSI Career Young Virtual Event (Q4 2025)