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.

Staburo at the ACDM Annual Conference 2025 in Prague

From March 2nd to 4th, Staburo colleagues Birte Clasen and Matthias Lehr attended the ACDM Annual Conference in Prague. With around 450 participants from over 180 organizations, the event brought together industry professionals for three days of knowledge-sharing, networking, and innovation.

Highlights included:

• Inspiring plenary sessions, such as the inspiring talk by Alicia Staley (Medidata) on patient-centric clinical research, based on her personal journey as a cancer patient and clinical trial participant.
• Breakout sessions covering key topics like Risk-based Quality Management (RBQM), Data Management Evolution, and Technology & Innovation.
• Engaging discussions around Audit Trail Review as part of RBQM, and AI solutions for Clinical Data Management.
• Poster presentations showcasing new research and approaches.
• A dynamic Demo & Live Lounge featuring cutting-edge tools for EDC, ePRO, and eCOA systems.
• Valuable networking opportunities at the evening socials, including a Conference Dinner with live music and awards.

Thank you to Birte Clasen and Matthias Lehr for representing Staburo’s Data Management Team and bringing back fresh insights!

 Learn more about our data management services.

Staburo supports transdisciplinary thesis advisory committee at TUM 

We’re happy to share that Staburo is supporting a Transdisciplinary Thesis Advisory Committee (TTAC) for a doctoral researcher at the Konrad Zuse School of Excellence in Reliable AI, based at TUM. 

The TTAC is tailored to each doctoral researcher, combining perspectives from both academia and industry. We are contributing to the advisory committee of a PhD student working on a thesis that focuses on modelling causal systems with dynamic processes. 

During regular meetings, we engage in discussions on the student’s progress, their individual development plan, and how to bridge their research with practical applications. As a representative from the industry, we’re proud to share industry insights and contribute to their academic journey. 

At Staburo, we value the opportunity to support young researchers by offering mentorship and highlighting potential career pathways.