Staburo @ workshop from IBS-DR working group Pharmaceutical Research (APF)

As usual, Staburo took part in the annual workshop of the APF (working group Pharmaceutical Research, of the International Biometric Society German Region) in Berlin on 25 November 2022. After two virtual APF workshops in 2020 and 2021 due to the pandemic situation, this year’s workshop finally took place again as a face-to-face meeting. The get-together evening event on 24 November was hosted by Cytel and it was a great opportunity to meet and discuss with other participants.

This year, the workshop had two parts. The topic of the morning session was “Planning and Estimands for Safety/Benefit-Risk”. The first two talks were about Aggregated Safety Assessment Planning and the trend to move away from isolated safety analyses and single-case evaluation toward benefit-risk assessment planning and a more quantitative approach based on frequency analysis. Other presentations were dealing with safety endpoints for HTA and with the question of what needs to be considered for building an estimand framework for safety.

The afternoon session was dedicated to the topic of “External and Synthetic Control Arms”. Attendees were first introduced to the subject with an overview of the benefits and pitfalls of external data as controls in clinical trials and strategies that can be applied when using external data. This was followed by talks about how multistate models can mitigate the problem of small sample sizes by borrowing information from external control data, and about synthetic control arms in regulatory and HTA assessments.

Many thanks for the great organisation. It was a great workshop, and we are already looking forward to 2023!

Staburo Christmas Party 2022

The anticipation for our annual Christmas party was great this year – finally an on-site Christmas party again. In the late afternoon, all Staburo team members met at Marienplatz in Munich. It was time for a city rallye, quizzes and riddles around the old-town, organized by the amazing guides from Weis(s)er Stadtvogel.

Small groups were formed, everyone got their rallyebook, and the challenge started. The rallye questions guided us across the old town and everyone still learned new facts about Munich. Of course the one or other mulled wine station could not be passed without a short stop.

After the active part on this very cold day, we all went to the spice bazar – a beautiful and declicious mediterranean oriental restaurant close to Hofgarten and the Opera in Munich. It was an evening full of chatting, laughter, nice food, drinks and last but not least a small award ceremony for our winners of the rallye and of some internal Staburo challenges in 2022.

What a joyful and successful conclusion of the year 2022!

We would like to thank all our employees, customers, partners and suppliers for a fantastic year.

We wish you all a happy, healthy and merry Christmas and all the best for the next year!

Meet the Management – Habib Esmaeili – Director Disclosure and Posting

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 Disclosure and Posting, Habib Esmaeili.

Who are you?

My name is Habib Esmaeili, Director of Disclosure and Posting of Staburo GmbH. I am a statistician by training, did my PhD in mathematical statistics at the Technical University of Munich (TUM), work for Staburo more than 11 years and have very deep experience with disclosure of clinical trials for more than 9 years now.

Tell us something about your area of expertise.

I am an experienced statistician and have very good expertise in data transparency of clinical trials. As a statistician, I support our clients in statistics from writing protocols and SAPs to reporting the results. As a disclosure expert, my team and I support clients to ensure the disclosure readiness of documents and data. We help trial teams to follow disclosure requirements and comply with transparency laws or policies. We are also responsible to provide sufficient and correct information to the public, based on clinical trial reports.

What are your goals for your role?

We have successfully created an expert team for supporting our clients in clinical trial registry, records maintenance, and results disclosure. As Director of Disclosure and Posting, I try to expand our expertise and services to all areas of data transparency, while keeping the quality high!

What motivates you as an individual?

Our daily work improves not only the quality of clinical trials, but also the life of patients, now and in the future. We provide information to the public such as researchers, students, and patients, for whom this information may improve their lives or advance their personal research on certain treatments. This is the biggest motivation for me as an individual!

What would you like to share about your personality that you believe it is useful for your role?

I believe in collaboration and teamwork, initiatives and growing together. I think creating a team with such skills in a friendly atmosphere at work leads to success in career for our team and our company!

Staburo @ BVMA Symposium 2022 in Munich

Staburo took part in the BVMA symposium on 25 November 2022, at the Westin Grand Hotel, here in Munich. This year it was the 30. BVMA symposium and for this anniversary the get-together took place the evening before at the SEA LIFE aquarium in Munich.

This year’s topic was: “New approaches in clinical research – Europe moves together”. The symposium presentations and discussions covered the areas of regulatory, decentralized clinical trials, first experiences in the area of CTR/CTIS and as well innovation and digitalisation within clinical research.

We were very happy to learn more about current changes in regulations and updates in the CRO market – thanks to the excellent networking sessions! Congratulation to the BVMA for the organisation of this great event and thank you for the invitation! We are already looking forward to next year’s BVMA symposium.

The BVMA represents the interests of its German CRO members. BVMA members maintain a lively exchange of information on topics that important to the German CRO industry, e.g. on questions of liability and insurance, education and training, quality requirements and trends in the pharmaceutical and CRO industry.