Statcon mainly works in the pharmaceutical- and biotechnology industry not only with clinical development but also with other tasks in connection with development and production of pharmaceutical products. We have worked with a lot of the pharmaceutical- and biotechnology companies in Denmark.
An interesting area in the clinical development programs is studies in phase I, which is closely connected to pre-clinical studies, and special studies, which is testing if a substance could cause QT extensions. Statcon also participates among others in planning and analysis of studies like these. We often participate as independent and possibly as unblinded statisticians in the current and detailed surveillance and analysis of safety data – typical in connection with the companies intern Clinical Safety Department.
We deliver statistical rapports or the statistical input to the integrated clinical rapport for typical phase IV studies and Post Marketing studies. Statcon collaborates with data managers, arranges data entry, and performs CRF-preparation and the statistical debriefing.