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!