Under the leadership of opinion leaders in the German market, palleos has developed and now executes one of the first bio- and genetic marker driven breast cancer studies in Germany with over 4000 patients and 80 sites planned. In this study, palleos manages the bio sample/tissue logistics, data management, monitoring, project management, and regulatory affairs. Besides the traditional elements important to the management of a clinical study, logistics, monitoring strategies, and regulatory strategies play an important role for this study. Palleos has established a risk based monitoring approach, which looks at various key performance indicators (KPI) to assess the state of logistics, documentation, safety, site governance, and overall study progress. Hence, on site visits are performed based on a site’s performance compared to the average or other standards. Such enables palleos to use resources for the processes and locations that require them the most.
Overall palleos offers the following services:
- Data management, statistical analysis, and planning
- Clinical trial management system (CTMS) to inform and integrate all involved stakeholders
- Training in all phases of the clinical trial process
- Services by providing support in conducting clinical trials
- Regulatory affairs
- Risk based monitoring