Every two weeks, the eXYSTAT teams come together for in-house training sessions to discuss common topics (study results, GDPR, quality, etc.). Last week’s session focused on the development of an AI charter within eXYSTAT, presented by Franck. The aim of this AI charter is to define a common framework for the use of artificial intelligence tools within eXYSTAT, in order to ensure transparent, responsible and consistent practices for all employees. During the two previous sessions, François Montestruc once again raised the teams’ awareness of the ‘estimand’ (ICH E9(R1)), through insightful discussions that enabled Data Managers to see that this concept is not merely statistical but is relevant to all those involved in clinical trials.

eXYSTAT attended last Wednesday’s meeting of the CDISC Groupement des Utilisateurs Francophones (GUF), held at the AP-HP’s Picpus campus in Paris. Nadège Thierry (Data Manager), Feriel Abdessalem (Work-study Data Manager) and Mickael Borne (Head of the Biostatistics Team) represented eXYSTAT and were delighted to take part in this day of fruitful discussions. On the agenda: fascinating discussions on the impact of AI on our industries, featuring a range of diverse and complementary perspectives, as well as a presentation on upcoming developments in CDISC standards (SDTM v3.0/SDTMIG v4.0, CDASH v2.0/CDASHIG v3.0, Analysis Result Metadata v2.0, etc.). A big thank you to GUF-CDISC and the speakers for the high quality of the presentations and discussions. As a CDISC Gold Member, eXYSTAT is proud to support the development and adoption of international standards in the service of clinical research.

Three new arrivals at eXYSTAT are strengthening our teams and supporting our growth. Louise MARGUERITE is joining us as Data Manager, Hélène SAVEL is joining the team of statisticians, bringing all her expertise to bear, whilst Benoit MACHABANSKI will be supporting us as part of his work placement. This new expertise represents tremendous opportunities for growth at eXYSTAT and helps to strengthen our ability to meet our clients’ challenges.

Émilie and Marion had the opportunity to discover the new features available and the upcoming developments in the V11 roadmap for the Ennov Clinical solution.A friendly event, full of lively discussions and exciting innovations to come… Watch this space!

Two days packed with discussions on current issues in data management in clinical research: ICH E6(R3), CDISC standards, REDCap, health data sharing, migration to R and artificial intelligence. Beyond the conferences, this event provided a valuable opportunity to share very practical insights into the evolving role of the Data Manager and the real-world challenges we face on a daily basis. It was also an opportunity for @juliebeaugitte and @Adélaïde Perrier to present the company.

François Montestruc is reporting back to the teams following the Euraica conference in Brussels in March 2026, which focused on ‘the integration of artificial intelligence into clinical research’. The impact on activities at both the individual and organisational levels is being discussed. Project management and customer relations must remain at the heart of the eXYSTAT 2030 strategy.

Structured around two workshops, this seminar provided an excellent opportunity to explore key topics such as project management and communication within teams and with clients. The discussions were fruitful and led to useful insights for the future.

Matthieu joined eXYSTAT in 2026 as Head of Data Management, bringing with him 20 years’ experience in the pharmaceutical industry (Novartis, Sanofi, Stallergenes) and in the services sector (VCLS). With a diverse background (Phase 1 to post-marketing authorisation and market access, from medicines to medical devices, and from oncology to rare diseases) and a strong interest in quality, standardisation and automation, he supports his team in driving eXYSTAT’s growth.

After completing a bachelor’s degree in health engineering in Montpellier, Fériel joined eXYSTAT on a work-study programme. She is currently pursuing a Master’s degree in Health Engineering, specialising in Clinical Operations Management and Data Management, and is involved in Clinical Data Management activities.

In 2025, eXYSTAT, in collaboration with its partners MDSTAT, OXALIS and Saryga, ran nine training courses, bringing together a total of 75 participants from a variety of backgrounds.These training courses brought together professionals from biotech, CROs and laboratories, as well as players from the investor and medtech sectors. This diversity of profiles greatly contributed to the richness of the exchanges and the quality of the discussions throughout the year.We would like to thank all the participants for their trust and commitment, which give meaning to our training activities.The 2026 training catalogue will be available online in early February 2026 with new additions. Qualiopi #Formation #Méthodologie #Biostatistique #DataManagement