Meet the management – Luciana Husfeld – Head of QA

For several years, the managing directors were the main contact persons for clients, potential candidates, and employees. 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). In order to give them a chance to talk about themselves and their passion, we will publish a news series about the management team members in the next months and will start with Luciana Husfeld.

Who are you?

My name is Luciana Husfeld, head of quality assurance (QA). I am by training a pharmacist and food chemist and made my PhD in immunology. My business experience includes many years of international work in various regulated areas such as pharmacy, cosmetics, medical devices, and nutrition. My team and I are responsible for the quality system at Staburo, predominately based on GCP.

Tell us something about your area of expertise.

We plan, support, and monitor all QA activities, and we are liable for the life-cycle management of all QA documents. We ensure compliance with training requirements, conduct internal trainings, and interact with all colleagues and Staburo departments. We are also responsible for the planning, implementation, and the follow-up of internal and external audits. Our quality team needs the following qualities: excellent knowledge about GCP, persistence, friendliness, support mentality, creativity, and ability to formulate standards with reasonable detail.

What are your goals for your role?

Our aim is, to continuously enhance Staburo`s quality system in order to offer our clients excellent service. We strive for zero findings in audits!

Staburo @ DAGStat 2022 in Hamburg 

Staburo statisticians joined the DAGStat conference 2022 in Hamburg, March 28 to April 1, hosted at the University Medical Center Hamburg-Eppendorf. One goal of the joint statistical meeting of the German Consortium for Statistics (Deutsche Arbeitsgemeinschaft Statistik, DAGStat) is to stimulate constructive discussions between the representatives of the various statistical areas summarized by the DAGStat theme >>Statistics under one umbrella<< (an umbrella being a conference present in Hamburg 😉). This year, the central DAGStat theme was complemented by the motto >>Mind the gap – Interplay between theory and practice<<. In this sense the Staburo statisticians updated themselves about current research topics which could be applied to biostatistical questions in their daily work. Research areas of interest included: Design of experiments and clinical trials, clustering and classification, statistics in the pharmaceutical and medical device industry, survival and event history analysis, the STRATOS (STRengthening Analytical Thinking for Observational Studies) initiative, causal inference, robustness of statistical conclusions, and cross-validation. As a lesson learned from SARS-CoV-2 pandemic and climate change, with extreme weather events, the role and importance of statistics and data science to science and society, and the need to prepare for future challenges was intensely discussed.

Staburo contributed data science expertise to medical device study 

Staburo supported the German pharmaceutical company, Dr. Pfleger Arzneimittel GmbH, Bamberg, during the whole lifecycle of the ‘ipalat® Hydro Med’ study in terms of protocol writing, randomisation, statistical analysis plan writing, statistical programming, report and publication writing. The prospective, single-dose, placebo-controlled, randomized clinical trial investigated whether sucking and chewing the ‘ipalat® Hydro Med’ pastille (class I, CE-certified medical device) containing a specific mixture of four different polysaccharides provides instantaneous relieving effects for acute oropharyngeal symptoms such as sore throat, difficulty swallowing, hoarseness, tickly throat, and dry mouth. Find out more about the study results being published here https://doi.org/10.2147/OAJCT.S331883