Meet Arithmos in Milan – Booth #18
Arithmos is delighted to be attending the CDISC Europe Interchange 2026, taking place in Milan, Italy, 20–21 May 2026.
Join us at Booth #18 to connect with our experts and explore how we help life sciences organisations design smarter, scalable solutions across clinical operations, data standards, and technology.
Whether you’re navigating evolving regulatory expectations, implementing CDISC standards, or modernising your clinical systems, our team will be on hand to discuss practical strategies and share insights from real-world implementations.
What to Expect at the Arithmos Booth
We’ve prepared a few interactive surprises to make your visit worthwhile.
⏱ Stop the Clock Challenge
Think your timing is perfect? Try our Stop the Clock activity and test your precision for a chance to win prizes.
☕ Collapsible Arithmos Cups
Pick up one of our branded collapsible cups, practical, reusable, and perfect for conferences on the go for your hot or cold drinks.
🎮 Arithmos’ Own Personalised Game
We have our very own personalised Arithmos-themed game to take play and enjoy. A fun and memorable way to experience the Arithmos brand and all things Clinical related.
Stop by, meet the team, and take part in our unique activities.
What You Can Discuss With Us
Our team will be available to talk about:
Risk-based TMF strategies aligned with ICH E6(R3)
CDISC standards implementation and optimisation
Metadata-driven Statistical Computing Environments (SCEs)
Clinical trial technology strategy and transformation
Sponsor–CRO operating models
Automation and AI in clinical data and analytics
Whether you’re exploring new approaches or scaling existing capabilities, we’d love to exchange ideas.
Meet the Arithmos Team in Milan
Business Development Manager
Chief Commercial Officer
Senior Consultant,
Clinical Business Partner
Head of Clinical
They’ll be available throughout the event at Booth #18.
Arithmos Presentations at CDISC Europe Interchange
From Flirting to Commitment: Tailoring Your Risk-Based TMF Strategy
📅 Thursday 21 May
🕘 09:00 – 09:30
Presenter:
Rob Jones, Head of Clinical – Arithmos
ICH E6(R3) is now in full force across regulatory agencies, and with it comes new ways of working and thinking about clinical trials. With the word “risk” appearing 89 times across the guidance, it’s time to move beyond experimenting with risk-based approaches and fully commit.
In this session, we’ll explore five practical methods for building a risk-based TMF approach, including:
Determining which records should be collected
Leveraging the metrics generated by your teams
Applying risk-based approaches across different study types
The role of technology in enabling risk-based decisions
The evolving relationship between sponsors and CROs
We’ll also discuss implementation strategies, the advantages and challenges of different approaches, and an important reality: while risk-based TMF strategies can reduce workload and increase confidence when implemented well, they can also increase burden if poorly executed. This session will show how to tip the odds in your favour.
From Data Traceability to Evidence Traceability: A Provenance Layer for CDISC Standards in Metadata-Driven SCEs
📅 Thursday 21 May
🕚 11:00 – 11:30
Presenters:
Massimo Raineri – Arithmos
Darius Testa – UCB
As organisations adopt metadata-driven Statistical Computing Environments (SCEs), the next frontier for CDISC standards is capturing analytical provenance.
While CDISC foundational standards, Define-XML, and the evolving Analysis Results Standard (ARS) provide traceability from data collection to analysis results, they do not describe how outputs are produced — including workflows, code versions, environments, and quality checks.
This presentation introduces a CDISC-aligned provenance layer extending ARS and supporting the CDISC360i vision of end-to-end automation. The model formalizes SCE audit-trail elements such as:
Workflow steps and execution metadata
Environment details and code versions
Reviewer actions and quality checks
AI-assisted analytical components
By linking these elements directly to ARS outputs, the proposed approach enables reproducible evidence generation, automated audit readiness, and improved interoperability across tools and vendors.
This framework expands CDISC’s mission from data traceability to full evidence traceability in an increasingly AI-assisted analytical landscape.
Let’s Connect in Milan
Planning to attend CDISC Europe Interchange?
Visit us at Booth #18 to meet the Arithmos team, take part in our activities, and discuss how we can help accelerate your clinical and data innovation.
About Arithmos
With deep expertise in the Life Science Industry, Arithmos supports companies in their digital transformation journey to achieve the best value from technology-enabled solutions and excellence in business operations.
Arithmos team share extensive knowledge of the full GxP regulated environment for both deliveries of services and technologies, and our domains range from Clinical Development, Quality & Compliance, Pharmacovigilance & Safety and, Regulatory Affairs.
