Transforming data into knowledge
At Statistical Revelations we have assembled a great team, led by Dr Annie Solterbeck (Statistics) and Arne Solterbeck (Data Management).
Dr Annie Solterbeck (nee Ann Dyke) holds post-graduate qualifications in both pharmacology and statistics therefore brings statistical rigour to medical research while preserving clinical issues in study design. Furthermore she can make statistical concepts understandable to the clinical scientist. These skills have been recognized by the Statistical Society of Australia (SSAI) through the award of the status of AStat (Accredited Statistician).
Arne Solterbeck brings post-graduate qualifications in marketing and business (MBA) and over 10 years experience in leading a team specialized in data management including database design and interactive web-based dynamic data warehousing/reporting solutions.
At Statistical Revelations we use SAS for most of our analysis work. This is the pharmaceutical industry standard software for statistical analysis. All analyses can be performed through programming which removes the need for any "cut and paste" or transcription between dataset provisions, results from statistical analyses and final reporting. In this way the regulatory requirement for transparency of process and results can be easily achieved. However, SAS is not the best for everything and we know that. In our standard toolbox are also R, Winbugs, CMA, RevMan, WinNonLin, to mention a few. We will use the best tool possible for the task at hand, which may be customised.
In addition, we can easily work with a range of tools to suit your specific requirements, solutions including SPSS, Sigmaplot, Minitab, SPlus etc
Data Management solutions are based on a variety of software depending on the right requirements to ensure data validity:
Also always investigating new tools!
The ultimate standard for study design, data management, statistical analysis and reporting is perhaps those applied to the pharmaceutical industry by regulatory bodies such as the American FDA, the European EMA and our Australian TGA.
At Statistical Revelations we have a full set of Standard Operating Procedures governing the handling of clinical data used for regulatory purposes based on the ICH guidelines (International Conference on Harmonisation) and for computer security, validation and operation based on the FDA guidelines. We are familiar with FDA, EMA and TGA guidelines and regularly update our knowledge via the web or directly through attendance at industry conferences such as DIA and PSI.