Staburo recently took part at the workshop of the IBS-DR (Internationale Biometrische Gesellschaft – Deutsche Region) working group “Non-Clinical Statistics”. The workshop was held as hybrid event: Online and at the same time in Ingelheim on 24 and 25 November 2022. It covered many exciting topics in the field of non-clinical statistics like toxicology, design of experiments, process, and stability monitoring.
A recurrent scheme has been that presenters provided insights on challenges for statisticians both in their working environment and on a professional level. State-of the art solutions to address questions that arise from the non-clinical research field were discussed and related against the background of common practises, guidelines, and regulations.
Many thanks to the organisers for this exciting workshop. It was a great opportunity to learn and exchange. We are already looking forward to the next workshop in that group!
Staburo also has a strong focus on non-clinical statistics. We interact with regulatory authorities, and we know and work according to their guidelines on a daily basis. Companies that want to progress non-clinical projects, and medical device companies within an increasingly regulated environment, can benefit from our experience, such as:
- Statistical and analysis planning for medical device trials
- Design of Experiments statistical input and recommendations
- Stability testing
- Dissolution testing
- JoS
- FDS
- Interaction with authorities (e.g. FDA, EMA) focusing on statistical design or data analyses
Please feel free to contact us at any time!
