Biomarkers that help patients to choose the best treatment option, play a key role in drug development and precision medicine. The talk introduced the Virtual Twin Method by Foster et al. (2011). It is a multivariate, tree-based method that identifies patients who may benefit from a certain treatment. The close relationship to prognostic and predictive biomarkers was illustrated, and the advantages and disadvantages compared to univariate methods were highlighted. This internal Staburo training was a great opportunity to share knowledge within our team and to start a very fruitful discussion about the Virtual Twin Method!

The Engaged Database – TED

With TED, users have access to a straightforward tool, based upon the European Medicines Agency (EMA) inspection database, which allows the comparison of the results of one or more audits, to a large number of audit results. The Engaged Database is owned and managed by Dr. Barbara Heumann, who also owns the independent auditing company, GXP Engaged Auditing Services.

Staburo’s contribution to TED

Staburo was already involved early in the development of TED, and majorly responsible for the creation of the PDF reports. The benefit for the users of TED is putting their audit results in context to all other entries in TED. These reports are created automatically, using the R programming software, implemented directly in an interface within the SQL data base. Staburo programmed the automatic creation of reports, and implemented it together with a data base programming provider. We communicated with and between the involved parties (GXP Engaged Auditing Services, data base programming, design expert, validation), provided statistical advice for the various elements inside the reports, balanced design and scientific soundness, implemented style requirements, and did (in parts) data validation.

Welcome our teammates Hans and Bobby!

We are very glad to welcome Hans Bauer and Bobby Reidy in our team. Hans and Bobby are both professionals with work experience and excellent education from first-class universities. They will support our clients in the areas of biostatistics & statistical programming. We are very happy and lucky to have you guys in our team!

We are proud to announce that due to our remarkable growth in biostatistics and statistical programming, we were recently moving to a new office location. We will continue to offer the same costumer-friendly service from our new address at Aschauer Str. 26b in Munich, which will allow us to serve our clients even better. Our new location is in the same building as the old office, with its well-run cafeteria and modern facilities. We got a huge upgrade in terms of more space, with our new kitchen and with improved IT infrastructure (new server room, new Dell server). We are very happy to receive your call, our phone number stays the same: 089 5527 1520 or just drop us an email to info@staburo.com.

Staburo participated in the APF meeting on 24 November 2017 in Freiburg. This year, the APF was hosted by Roche. Speakers from pharmaceutical industry, academia and regulatory agencies discussed important topics on estimands, safety and Health Technlogy Assessment.

The APF (Arbeitsgruppe Pharmazeutische Forschung) is a German pharmaceutical research working group for statisticians in the pharmaceutical and healthcare industry, academia and regulatory agencies. The APF is part of the International Biometric Society.

We also attended the get-together on 23 November 2017 at the restaurant Großer Meyerhof. It was a great opportunity to meet other statisticians.