Staburo @ the DIA Global Clinical Trial Disclosure & Data Transparency Conference 2020 

Staburo participated in the 2020 Global Clinical Trial Disclosure & Data Transparency Conference hosted by the Drug Information Association (DIA) from the 16 – 18 November, this year online due to – you guessed it – covid19.

During the conference different regulatory agencies such as the FDA and the EMA provided updates concerning their disclosure platforms. The FDA provided an overview of new and upcoming features of ClinicalTrials.gov which are of immediate use to us in our day to day work disclosing studies on this platform. The EMA discussed the upcoming release of their new central European disclosure platform CTIS (Clinical Trials Information System) which will mark a major shift in the way clinical trials are disclosed in the EU.

Besides the regulatory agencies a range of industry experts joined the conference, leading to interesting discussions about topics such as the global harmonization, BREXIT, disclosing medical device studies and the future of clinical trial regulation. These talks provided valuable insights into the current state and future goals of global clinical trial disclosure.

We are looking forward to participating in next year’s conference where we can hopefully meet the speakers and attendees in real life!

If you have any questions about our disclosure services, don’t hesitate to contact us!

Staburo @ working group pharmaceutical research (APF) workshop 

Staburo Managing Director Dr. Hannes Buchner will talk about “Estimands update: Summary of world-wide authority interaction” together with Kaspar Rufibach from Roche at the 74th Arbeitsgruppe Pharmazeutische Forschung (APF) workshop on November 27, 2020.

The current workshop will take place virtually on November 27, 2020, on the topic “COVID-19: Effects on statistics, methodological aspects and operational implications”. The current agenda can be found here: http://www.biometrische-gesellschaft.de/fileadmin/AG_Daten/PharamzeutischeForschung/PDFs/Agenda_APF_74_virtuell_Nov_2020.pdf

APF aims to establish contacts between biometricians working in pharmaceutical research and development, to accelerate the exchange of methods among colleagues and, if necessary, to develop new methods, as well as to transport mutual information on official regulations, methodological developments and scientific events.

Pre-registration for the workshop and for the virtual evening meeting is required and can be done here: http://www.biometrische-gesellschaft.de/fileadmin/AG_Daten/PharamzeutischeForschung/PDFs/Anmeldung_APF_Workshop_Nov2020_01.pdf 

To register, please download the registration form, fill it out and follow the instructions in the document. Registration is requested by November 20, 2020.

Introduction to Statistics online course 

Our first course “Introduction to Statistics course” will be a 2-day course 02-03 November 2020!

The course, which takes place online, is about providing a solid foundation in Statistics through practical application and with mathematical details kept to a minimum. Topics will be descriptive Statistics (how to summarize data), exploration of data, graphics, and presentation of data, assessing significant differences between groups, investigation of associations and correlations and basic trend analysis.

This course is designed for anyone wishing to understand basic statistical techniques thoroughly, e.g.: Clinical Research Associates, Project Managers, Team Managers, Principal Investigators, Medical Professionals, CMC Managers, Regulatory Affairs Managers.

The course will be held in English and the detailed agenda will be sent out a few days before the start of the course. You find more details here!

Staburo GmbH launches “Staburo Academy” (www.staburo.de/academy/)!

Staburo is specialized in Biostatistics, Statistical Programming and Data Science. We cover a wide range of statistical services and develop tailor-made client solutions.
We love to share our statistical expertise and therefore we offer specific training programs. Our coaches are statisticians with a broad practical knowledge and teaching experience. The trainings can range from basic to very state-of-the-art statistical topics. All courses will be tailored to the specific interests of the audience. However, our portfolio of existing courses can help to find the right combination of topics.
There will be several Staburo training courses. For example:
– Introduction to Statistics course
– Introduction to R course
– Advanced statistical methods course
– Machine learning and high-dimensional methods course

Our first online course “Introduction to Statistic course” will be a 2-day online course on 02-03 November 2020! Apply now on www.staburo.de/academy/ !

Staburo @ conference of the GMDS & CEN-IBS 2020

Dr. Hannes Buchner, Managing Director from Staburo participated in this online Conference on 08 SEP 2020 and talked about the topic “Children and Career” together with Benjamin Hofner from PEI, Cornelia Kunz and Julia Igel from Boehringer Ingelheim, Marvin N. Wright from Leibniz Institute for Prevention Research and Epidemiology and Antonia Zapf from the UKE (Universitätsklinikum Eppendorf). This session was part of the Podium Discussion: “Traditional vs. new career paths in Data Science” (Hüls/Kunz). The abstract of this session can be found at the end of this post.

After a short introduction, Hannes talked about Staburo´s concept for a good work-life-balance which is in fact not limited to parents but to employee needs in general. This includes most importantly home office and flexible working hours for everyone as well as permanent contracts and individual arrangements for contracts.

Please be aware of the other 2 GMDS & CEN-IBS contributions from Staburo, which will be published as recorded sessions:

• Estimands in treatment switching (Juliane Manitz and Hannes Buchner)
• Pre-specified matching analyses in an observational study (Lena Herich and Hannes Buchner; both Staburo)

It was the 65th Annual Meeting of the German Association for Medical Informatics, Biometry and Epidemiology (GMDS), Meeting of the Central European Network (CEN: German Region, Austro-Swiss Region and Polish Region) of the International Biometric Society (IBS) including the 66th Biometric Colloquium of the German Region. They agreed on a small online format (https://www.gmds-cen-2020.de/scientific-program).

Abstract:
Kinder? Karriere? Beides! Viele Nachwuchswissenschaftler/innen fragen sich, wie man Familie und Beruf am besten vereinbaren kann. Fragen wie “wann ist die beste Zeit eine Familie zu gründen?” oder “ist es möglich, Karriere in der Industrie oder der Wissenschaft zu machen und gleichzeitig Kinder zu erziehen?” beschäftigen viele junge Berufstätige.

Die Session gibt Einblicke von Eltern, die bereits die Herausforderung, Familie und Beruf zu vereinbaren angenommen haben. In mehreren Kurzvorträgen berichten Mütter und Väter von ihren Erfahrungen, sowie den Höhen und Tiefen ihrer persönlichen Wege. In der anschließenden Podiumsdiskussion werden Themen wie “Kinder lieber früher oder später bekommen”, “Industrie versus Wissenschaft”, “Elternzeit und Teilzeit” sowie “Auslandsaufenthalte und Dienstreisen mit Kind”, “Umzug und Jobwechsel” diskutiert.

 Die Session soll Nachwuchswissenschaftler/innen und jungen Berufstätigen Mut machen, Kind und Karriere mit einander zu vereinbaren, zum Erfahrungsaustausch zwischen berufstätigen Eltern anregen, und ein Bewusstsein für die Wünsche und Herausforderungen bei Vorgesetzten schaffen.