Staburo academy – Clinical trial disclosure & transparency online workshop

There is an increasing demand for transparency in clinical trials. This interest in transparency is not only demanded by the public but also by global regulators like FDA (US) and EMA (EU), with the overall aim being to make as much clinical trial information public.

For study managers in smaller companies and in academia it can be hard to keep up with this constantly evolving landscape of regulations. Additionally, the scope of required information, the increased demand for disclosure of documents, and actual data entry into platforms is often challenging.

This interactive workshop is designed to bring you up to date with the currently applicable regulations. We will have group sessions to practice protocol and results data entry into the platforms and will give advice on handling timelines and necessary record updates. Following this workshop, you will be confident in disclosing your studies in full compliance with applicable regulations and your own transparency goals.

The workshop is addressed (but not restricted) to industry or academia professionals who are interested in clinical trial disclosure and transparency.

The course will be held in English and takes place on 25th & 26th of May 2023. You can find more details here.

For questions and registration please contact: academy@staburo.de

Looking forward to seeing you in the online workshop!

Meet the Management – Lena Herich – Director Biostatistics

Since our team grew substantially, we searched, appointed, and enabled a bigger management team at Staburo, consisting of two heads (of departments) and six directors (focus on data science topics). We want to give them a chance to talk about themselves and their passion! Therefore, we publish a mini news series about the management team members and will continue with our Director Biostatistics, Lena Herich.

Who are you?

My name is Lena Herich, I am Director of Biostatistics with the focus area of Early Clinical Development. After my diploma in the field of mathematics, I have done my PhD at the University of Hamburg during which I have developed a strong interest in data analysis in medical research. Since then I have been working for many years as a biostatistician in clinical trials, in many different indications and study phases.

Tell us something about your area of expertise.

In the last years, I have focused on the field of early clinical development. At Staburo we are working on a high number of early phase trials, comprising for example single and multiple rising dose trials or studies investigating drug-drug interactions or relative bioavailability / bioequivalence.

What are your goals for your role?

Our team at Staburo already has strong experience in this area. The aim is to keep the group of biostatisticians growing steadily, while keeping the quality high. Additional goals are to ensure continuous training of our employees and to encourage the exchange between colleagues.

What motivates you as an individual?

It motivates me to work in an area that aims to improves the life of patients. I am always happy to learn more about different methods, trial designs, or areas. Moreover, I highly appreciate the open exchange and good working climate that we are having in the company!

Staburo @ workshop from IBS-DR working group “Non-Clinical Statistics”

Staburo recently took part at the workshop of the IBS-DR (Internationale Biometrische Gesellschaft – Deutsche Region) working group “Non-Clinical Statistics”. The workshop was held as hybrid event: Online and at the same time in Ingelheim on 24 and 25 November 2022. It covered many exciting topics in the field of non-clinical statistics like toxicology, design of experiments, process, and stability monitoring.

A recurrent scheme has been that presenters provided insights on challenges for statisticians both in their working environment and on a professional level. State-of the art solutions to address questions that arise from the non-clinical research field were discussed and related against the background of common practises, guidelines, and regulations.

Many thanks to the organisers for this exciting workshop. It was a great opportunity to learn and exchange. We are already looking forward to the next workshop in that group!

Staburo also has a strong focus on non-clinical statistics. We interact with regulatory authorities, and we know and work according to their guidelines on a daily basis. Companies that want to progress non-clinical projects, and medical device companies within an increasingly regulated environment, can benefit from our experience, such as:

• Statistical and analysis planning for medical device trials
• Design of Experiments statistical input and recommendations
• Stability testing
• Dissolution testing
• JoS
• FDS
• Interaction with authorities (e.g. FDA, EMA) focusing on statistical design or data analyses

Please feel free to contact us at any time!

Movie Night @ Staburo

On a Friday night, 18 Staburo team members, 6 big pizzas, popcorn, a bunch of other snacks, soft drinks, and beer. What could this mean? It was about time for our Staburo team movie night.

Finally, the time had come – some of our colleagues have been waiting for years for this event to happen. Originally it was planned in Friday, 13 (!) March 2020. What happened next is still known to us all.

Ironically, the movie “Twelve Monkeys” had already been selected to be shown that evening in early 2020. The movie “Twelve Monkeys” is an American science fiction film, already published in the year 1995 and tells the story about a prisoner who goes back in time to avert a deadly plague.

For this evening, our big meeting room was equipped with all comfortable armchairs and sofas we could find in our office. Around 6pm the group started with food, drinks and even a small presentation from one of our team members. He prepared an entertaining presentation about the main characters of the movie.

Thanks to the organiser for the amazing movie night and the great catering.

Solidarity and fun are not only part our core values, also something that is lived at Staburo and our team enjoys it very much. Thus, quite a few other team events – organised internally by team members, for example a running dinner night or climbing & skiing activities – already happened or are in the making.

We are looking forward to the next team activities!

Staburo @ Statistical Colloquium of FU Berlin

Staburo Managing Director Hannes Buchner will give a talk about “Applied Biomarker analyses in drug development. Lasso, random forest, longitudinal biomarker analyses” at the colloquium “Statistische Methoden in der empirischen Forschung” (“Statistical methods in empirical research”) at the Freie Universität Berlin on February 14, 2023.

The presentation is a collaboration of our Staburo employees Laura Schlieker, Armin Ott, Stephan Bischofberger and Gabriele Bleckert and will provide insight into how random forests, LASSO and IPF-LASSO (Integrated LASSO with Penalty Factors) can be applied to investigate the prognostic and predictive potential of high dimensional biomarker data by using training and test data principles, subsampling methods and permutation concepts. In addition, the application of mixed models with repeated measurements and the concept of sliding regression for analyses of longitudinal biomarker data and their pharmacodynamic features will be addressed.

At the colloquium, which is organised by a committee of members of various institutions and companies, such as Pfizer, Bayer, Parexel and Cytel, speakers from academia and industry present current topics in biostatistics, medicine, epidemiology, agriculture, or other fields of application once a week. It is open to the public and all those interested in empirical research and statistical research are welcome to attend in person or virtually! More information can be found on the institute’s website.

We look forward to numerous listeners and to welcome you within the audience!