1st April 2026

AB Cube Newsletter: Spring 2026

Welcome to the Spring 2026 edition of the AB Cube newsletter!

We open this issue with exciting news: we’re now part of the newly-created AB Cube Group. This new group structure in Europe unites SafetyEasy® with industry-leading life science solutions Marvin and asthenis to create a powerful total solution for our customers. Discover the new capabilities offered by this fully integrated portfolio – connecting oncology documentation, real‑world and clinical trial data, and pharmacovigilance and safety workflows.

Next, we share a look-ahead to our 2026 product roadmap, plus focus on our recent website refresh and the latest resources and insights now available for you to explore.

In our Regulatory & Functionalities Update feature, we preview the latest and upcoming enhancements across the SafetyEasy® platform, designed to strengthen compliance, improve interoperability, and deliver greater customization. From FDA E2B(R3) regulatory alignment to advanced system controls, we bring you up to speed on our newest performance-boosting developments.

Finally, we round up the hot themes and key takeaways from last month’s events, and flash forward to the upcoming dates and opportunities to meet in our industry event calendar.

Ready to level up your safety processes with next-gen AI and smart automation? Connect with us at our upcoming events or schedule a SafetyEasy® Suite demo by emailing [email protected].

Thanks for being part of this edition, and we look forward to staying connected across upcoming events, digital channels, and in‑person meetings.

Best regards,

Matthieu Doresse
Founder & CEO, AB Cube
+33 185 34 94 79
[email protected]

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AB CUBE NEWS: AB Cube Group – A Stronger, Integrated Partner for SafetyEasy® Customers

We’re excited to share an important milestone for AB Cube: industry-leading life science solutions Marvin, asthenis, and SafetyEasy® are now united under the AB Cube Group – creating a fully integrated portfolio that connects oncology documentation, real‑world and clinical trial data, and pharmacovigilance and safety workflows.

As part of this evolution, EvidentIQ Germany GmbH now operates as AB Cube Germany GmbH, which also now integrates asthenis Medical GmbH. This strengthens our Group presence across Germany and Europe and expands the capabilities available to our customers across the life sciences sector.

This transformation brings together three complementary strengths:

Marvin – clinical data management for clinical trials and registries, with a strong focus on oncology workflows
asthenis – tumor documentation, oncology registries, and multidisciplinary tumor boards
SafetyEasy® Suite – pharmacovigilance, vigilance, and regulatory safety workflows

What this means for SafetyEasy® customers?

1. A broader, more connected ecosystem of data
SafetyEasy® customers now benefit from seamless links to clinical trial data management, oncology documentation and real‑world data capture, plus tumor boards and multidisciplinary workflows. This creates a complete picture across the product lifecycle – from clinical development to post‑market safety.

2. Stronger integration across safety and clinical workflows
SafetyEasy® now sits within a unified suite that connects:

Pharmacovigilance and vigilance reporting
Regulatory compliance
Clinical and real‑world oncology data

This alignment supports faster insights, improved data quality and more efficient regulatory processes.

3. A single partner for end‑to‑end life science data needs
With Marvin, asthenis, and SafetyEasy® now under one roof, AB Cube Group offers a consolidated, Europe‑wide platform that simplifies vendor management and accelerates digital transformation for life science organisations.

4. Continued commitment to innovation
AB Cube remains a pioneer in cloud‑based and AI-driven multivigilance management. The SafetyEasy® Suite ecosystem continues to evolve with:

Deeper automation
Stronger interoperability
Scalable, compliant workflows for global safety teams

This organizational transformation strengthens our ability as a Group to support customers across clinical research, oncology care and regulatory safety – all with the trusted reliability and flexibility that SafetyEasy® users expect.

If you have any questions about the new AB Cube Group structure or would like to learn more about how it enhances our total solution offering to life science companies, our team is here to help.

AB CUBE NEWS: The Future Starts Now – What To Expect During 2026

Every year, we ask ourselves one question: how can we make pharmacovigilance and clinical data management smarter, faster, and more connected?
This year, we’re answering that question with bold innovations that redefine what’s possible.

CasEasy V3
Imagine case processing powered by next-generation AI and a sleek, intuitive interface designed for the way you work.
Converter V2
Speed matters. That’s why we’ve cut time-to-production to just 3 days, backed by advanced AI for effortless conversions.
SafetyEasy® Vigilance Multizone
Global compliance is no longer a challenge – it’s a reality. This year, we’re expanding to Korea and Japan, bringing true multizone vigilance to life.
New API Capabilities
Seamless data exchange with E2B import/export means fewer barriers and more interoperability.
Reconciliation Module
Strong links with EDC providers, reduced reconciliation time, and optimized budgets – because efficiency should never compromise quality.

And that’s not all – also coming during 2026:

Signal Management Module
RWE Module

This year is about intelligence, agility, and global reach. Follow our journey, connect with us for exclusive preview demos of solutions that don’t just keep up with the industry – they set the pace.

AB CUBE RESOURCES: Have you visited our brand-new website yet?

Our new AB Cube website is live – and so is our enhanced News & Updates section!

This dedicated space brings together Regulatory Insights, AB Cube announcements, and a growing library of downloadable resources designed to support PV and regulatory teams.

Discover the latest downloadable resources now available.

AB CUBE RESOURCES: New PV SaaS whitepaper – EU versus US providers

DOWNLOAD OUR NEW WHITEPAPER: Pharmacovigilance SaaS: Key Differences Between EU & US Providers

An essential comparison of EU vs. US SaaS models, highlighting GDPR‑driven advantages, regulatory differences and key technical considerations.

If your organisation is evaluating PV safety technology, our new whitepaper is essential reading. Our latest whitepaper breaks down the critical distinctions shaping the future of pharmacovigilance SaaS — and why GDPR‑centric European solutions deliver superior compliance, data privacy, and operational agility compared to US platforms.

What you’ll discover:

How GDPR‑driven solutions deliver stronger compliance and data protection
Expert insights on regulatory frameworks
Key technical and operational differences between EU and US SaaS providers
Strategic considerations for global pharma teams selecting PV technology
Why data architecture, storage and auditability matter more than ever

Unlock authoritative perspectives & analysis that can reshape your PV strategy and strengthen your compliance.

Download the whitepaper now from the AB Cube website.

AB CUBE RESOURCES: New datasheet – Raising the Bar for AI in Drug Safety

DOWNLOAD OUR CIOMS XIV ANALYSIS: Raising the Bar for AI in Drug Safety

A clear 2‑page breakdown of how CIOMS XIV is shaping responsible AI in PV, from risk‑based oversight to transparency and performance benchmarks

The recent Council for International Organizations of Medical Sciences (CIOMS) XIV report is shaping industry perspectives on responsible use of AI in pharmacovigilance — and AB Cube is stepping forward with a fresh, concise analysis of what these principles mean in practice.

Our new 2‑page datasheet, “Raising the Bar for AI in Drug Safety”, breaks down the essentials and highlights how AB Cube’s SafetyEasy® solutions are built for a future where:

Oversight is risk‑based
AI performance is benchmarked to humans
Transparency isn’t optional
Robustness is the expectation

Rather than stopping at compliance, we explore what it takes to lead on this key issue.

Why this matters

As AI becomes central to global PV operations, organizations need clarity on:

What “good” looks like under CIOMS XIV
How to evaluate AI performance responsibly
What transparency and governance should really mean

Ready to see how AB Cube is shaping the next chapter of AI in drug safety? Download the full analysis.

REGULATORY & FUNCTIONALITIES UPDATE

We are pleased to share an overview of the latest and upcoming enhancements across the SafetyEasy® platform, designed to strengthen compliance, improve interoperability, and offer greater customization flexibility.

API & Data Exchange

New Import/Export XML Endpoints supporting E2B(R2) and E2B(R3) for smoother integrations and automated case exchange workflows.

Advanced Anonymization Controls

Introduction of customizable anonymization rules for all case outputs, aligned with:
- EU GVP Module VI – Addendum II (Masking of Personal Data)
- UK Data Protection Act 2018
- Receiver‑specific anonymization requirements

System & Dictionary Updates

MedDRA new languages available: Slovenian, Slovakian, Norwegian.
Custom fields: Organizations can now fully customize all system fields – new or existing – to fit their workflows and terminology.

E2B(R3) for FDA – Regulatory Alignment

E2B(R3) XML export for FDA is already available.
FDA‑specific validation will be added shortly.
FDA Gateway (ESG) integration is planned for Release 32.
Ready ahead of the FDA’s 1 April 2026 E2B(R3) implementation deadline.

Release 33 ready

Email Manager customization options for tailored communication flows.
New MIR v7.3.1 support (effective 01 May 2026).
Introduction of targeted FUQ Alerts, aligned with the EMA Guideline on Specific Adverse Reaction Follow‑Up Questionnaires.

EVENT REVIEW

European Drug Safety & AI 2026 | Feb 25 – 26 | Barcelona | Spain

This event gathered industry leaders and executives for a deep dive into how AI and automation arereshaping PV – from signal detection to compliance.

Key Takeaways:

Human‑in‑the‑loop AI remains essential for trustworthy PV systems

Sessions highlighted that, despite rapid progress in generative AI and predictive models, meaningful human oversight is still the cornerstone of safe and compliant AI deployment in pharmacovigilance. Discussions reinforced the importance of hybrid human–AI workflows, aligning with evolving workforce expectations and preserving accountability in safety decision‑making.

Inspectors’ expectations on AI are emerging in a landscape with limited governance frameworks

A particularly insightful session explored how regulators and inspectors currently assess AI systems – despite the absence of harmonized governance standards. Key themes included transparency, explainability, risk‑based validation, and documenting AI decision pathways. Participants emphasized the urgent need for industry‑wide frameworks to support governance, compliance, and audit readiness.

AI adoption challenges remain real – shaping the evolution of PV team roles

Real‑world implementation examples highlighted the operational barriers organizations face, spanning data quality, integration hurdles, change‑management demands, and cultural resistance. These challenges are redefining PV roles, with professionals increasingly expected to develop digital fluency, collaborate effectively with data‑science teams, and maintain accountability as AI scales across signal detection, triage, and literature monitoring.

WEBINAR: 2026 ROADMAP | March 17 2026 | Online

We kicked off 2026 with our first webinar of the year, marking the beginning of AB Cube’s 20th anniversary celebrations. The session brought together customers and partners for an exclusive look at what’s ahead for the SafetyEasy® platform.

Key moments from the webinar included:

Presentation of our 2026 roadmap, centered on enhanced security, resilience, and future‑readiness of the SafetyEasy® suite.
A regulatory outlook for 2026, with insights on FDA E2B(R3) readiness, MIR updates, and evolving global privacy expectations.
A preview of our near‑touchless case lifecycle, showcasing further automation across the platform.
The introduction of our next‑generation AI modules — CasEasy V3 and Converter V2 — bringing improved extraction accuracy, faster configuration, and reduced deployment times.

This webinar set the tone for a year dedicated to quality, compliance, and customer‑driven innovation.

DIA Europe 2026 | March 24 – 26 2026 | Rotterdam | The Netherlands

DIA Europe 2026 took place 24–26 March in Rotterdam, bringing together regulators, industry leaders, HTA bodies, patient representatives, and innovators from across Europe.
Top Highlights:

Collaboration, innovation & sustainability were the core themes guiding all sessions – with a strong focus on building a more resilient and sustainable healthcare ecosystem.
Discussions explored how to bring and retain innovation in Europe, including regulatory evolution, market access, and future‑ready development pathways.
Significant attention was given to the environmental impact of pharmaceuticals and how the industry can integrate sustainability throughout the medicinal product lifecycle.
The event provided a high‑level platform for cross‑sector collaboration, enabling EMA, national agencies, industry, HTA bodies and patient groups to align on practical solutions to pressing regulatory and healthcare challenges.

This year’s edition reinforced DIA Europe’s role as Europe’s leading neutral forum for shaping the future of drug development, regulatory science, and health system sustainability.

UPCOMING EVENTS

Thank you and see you at the next one!