Staburo At ICH E6 (R3) Training 

We were delighted to welcome two highly experienced trainers, Dr. Andreas Berk and Helge Bonaventura from InnovationTriologie, to our Munich office for an engaging hybrid training session on the updated ICH E6 (R3) guideline. The training offered a comprehensive look at both GCP basic principles and the key changes from ICH E6 (R2) to the new R3 version, making it valuable for colleagues at all levels of experience. 

The friendly and open atmosphere encouraged participants to ask interesting questions and share their perspectives, enriching the learning experience for everyone. 

A coffee break offered the chance to network and reflect on the morning’s content, and we enjoyed a relaxed lunch afterwards with the trainers, providing further opportunity for exchange in an informal setting. 

We would like to thank Dr. Andreas Berk and Helge Bonaventura for their expert guidance and Q&A opportunity after the session, and all attendees for their active participation.  

At Staburo, we prioritise maintaining awareness of evolving regulatory requirements, as they form a fundamental part of our commitment to quality and excellence in clinical research. 

Staburo welcomes its 100th employee

We’re proud to announce an important milestone in our company’s journey. Staburo GmbH has officially grown to a team of over 100 professionals! This achievement is more than just a number — it reflects our ongoing commitment to delivering high-quality health data science solutions.

From our early days, we are a trusted partner for pharmaceutical, CRO, and biotech companies.

This milestone is a testament to the impact of our team’s work and the strength of the collaborations we’ve built over the years.

We are incredibly thankful to our clients who have placed their trust in us, and to every team member who has helped shape Staburo into what it is today.

As we look toward the future, we remain committed our core purpose: Excellent data science to save and improve lives

Staburo Walk & Run Event 2025

This May, we came together once again for our annual Run & Walk event — a long-standing tradition that brings colleagues outside the office to connect, recharge, and share time together in a different setting.

We left the office in the afternoon and met near the Tierpark entrance. The atmosphere was filled with anticipation and connection as colleagues prepared for a 3 km walk or a 6 km run, following a group warm-up. The setting, the movement, and the shared experience made it a truly enjoyable afternoon.

We were especially pleased to welcome several remote colleagues who travelled in to join us in person, adding to the sense of unity and making the occasion even more meaningful.

After the activity, the teams regrouped for a fun quiz session. Formed on the spot, the teams competed in rounds of light-hearted trivia — a great way to continue the energy and teamwork in a more relaxed format. Congratulations to the winning team and thank you to all who took part.

The event concluded with a casual picnic by the Isar “beach,” with food and drinks from La Tarti, plenty of conversation, and even a few spontaneous games of volleyball. It was the perfect way to round off the day.

A big thank you to everyone who participated, whether from nearby or further away. Special appreciation goes to the organizing team for making the day seamless. It was a true celebration of team spirit and shared experience — and we look forward to more moments like this in the future.

Staburo @ EMWA Webinar 2025

Inspired by the internal Estimand Strategic Initiatives Working Group—and through many fruitful discussions with biostatisticians, disclosure managers, and medical writers, our Senior Disclosure Manager and Medical Writer, Ulrike Fischer has come to appreciate just how essential estimands are across the medical writing landscape.

The Estimand Strategic Initiatives Working Group, which ran for over a year, explored how the ICH E9(R1) estimand framework influences key clinical development documents, including clinical study protocols, statistical analysis plans, clinical study reports, and disclosure activities. The group examined how endpoints and intercurrent events are handled differently depending on the study phase or indication—whether in oncology, infectious diseases, or diabetes—and learned from colleagues engaged in wider industry initiatives, such as the “Reporting of Estimands” subgroup of the Estimand Implementation Working Group (EIWG) at EFPIA.

In parallel, as an active member of the European Medical Writers Association (EMWA), Ulrike presented a poster at the recent EMWA Spring Conference in Valencia: “An Attempt to Translate Estimands into Plain Language.”
The poster aimed to bridge the gap between complex estimand concepts and clear, accessible communication. Through conversations at the conference and on LinkedIn, Ulrike found that while many medical writers are familiar with the estimand framework in theory, relatively few have applied it in practice. It became evident that, so far, estimands have only marginally entered the day-to-day world of medical writing.

Recognising that medical writers serve as connectors across disciplines, Ulrike emphasizes that developing a strong understanding of estimands enhances how clinical documents are authored, reviewed, and structured—bringing greater clarity and scientific rigor to the work.

Another highlight of the year was hosting the webinar “Estimands in Protocols” for the EMWA Regulatory Writing Special Interest Group in April.
Over 100 medical writers from around the world participated, contributing to lively, thought-provoking discussions and providing encouraging feedback. She is grateful to her colleagues, the EMWA community, and the inspiring co-leaders who helped make the webinar such a success.

Looking Ahead: EMWA Spring Conference 2025
Ulrike is excited to participate in the upcoming EMWA Spring Conference this May in Riga. She is looking forward to connecting with colleagues and continuing the conversation about estimands and the evolving role of medical writing.

Staburo @ DAGStat conference 2025

From March 24 to March 28, 2025, the Staburo team had the pleasure of attending DAGStat 2025 in Berlin – one of the leading events for statisticians across academia, industry, and regulatory science.

We’re proud that Staburo was one of the sponsors of the conference. It was great to see our logo across the venue and to be part of such a vibrant community.

Our team members – Susanne Steinhauser, Maria Blanco, Gilary Vera Nuñez, Dr. Stephan Bischofberger, Habib Esmaeili, PhD, Tim Müller, Dr. Hannes Buchner, Dr. Josef Hoefler, and Roland Stieger – were actively involved throughout the week: Exchanging ideas, joining engaging discussions, and exploring the latest advances in statistical methodologies.

Our scientific contributions included four well-received presentations:

▶️ Forecast of Events for Study Analysis Planning (Christian Kappeler, PhD; Jakob Winkler; Wei Zhong; Ying He; Dr. Hannes Buchner)

▶️ Comparison of cLDA vs MRMM for Patient-Reported Outcomes (Dr. Stephan Bischofberger; Gilary Vera Nuñez; Dr. Hannes Buchner)

▶️ Evaluation of Event Rate Differences Using Stratified Kaplan-Meier Estimates (Maria Blanco; Dr. Stephan Bischofberger; Prof. Dr. Bernard Haller; Dr. Gabriele Bleckert; Prof. Dr. Eva Hoster; Dr. Hannes Buchner)

▶️ Permutation-Based Multiple Testing-Controlled Variable Selection Using Random Forests (Tim Müller; Prof. Dr. Silke Szymczak; Dr. Roman Hornung; Dr. Hannes Buchner)

The thematic focus on “Statistics in Times of AI” led to a particularly engaging panel discussion. It was exciting to hear diverse viewpoints on how AI can support and enhance statistical methodologies. The format was interactive, with real-time polls and Q&A participation via smartphone – a great way to connect with the audience.

Among the standout moments was the keynote by Phillip Young, who offered a thoughtful, non-technical talk based on his extensive experience in the pharmaceutical industry. He shared real-world challenges and lessons from drug development, as well as the regulatory interactions behind the scenes.

Finally, the welcome reception and conference dinner offered fantastic opportunities to network in a relaxed setting, with great food and even better conversations.

All in all, DAGStat 2025 was a rewarding experience for Staburo – full of insights, inspiration, and great connections. We’re already looking forward to the next edition!

Staburo implements Git for Version Control in Statistical Programming 

At Staburo, we’re continuously improving the quality and efficiency of our statistical programming workflows. As part of this commitment, we have successfully integrated Git as a version control system into our established folder structure. 

This step enhances key aspects of our programming processes: 

• Collaboration: Multiple team members can now work on the same project with full transparency and coordination. 

• Traceability: Changes to code are clearly documented, making it easier to review and audit. 

• Error Recovery: We can now revert to previous code states with precision, minimizing risks and downtime. 

Git is now embedded in both our SAS and R toolchains, which we use for delivering high-quality clinical research outputs. This integration aligns with our high standards for compliance and quality assurance, ensuring that every analysis is efficient, reproducible, and reliable. 

📬 Interested in working with us? 
Reach out to us, and we can explore your potential project together at : proposal@staburo.de.