Dear Visitor

Welcome to this homepage providing information about my services to the Pharmaceutical Industry, Manufacturers of Medical Devices and to Contract Research Organizations.

I am a clinical monitor with 10 years experience as employee in the pharmaceutical industry followed by 13 years as freelance CRA based in Germany.

During the past years I have had the possibility to gain profound experience and expertise in a large number of tasks related to clinical research. The involvement in a wide range of project steps from first study concept and budget brainstorming sessions as well as study design feasibility discussions, via all steps of clinical trial set up and supervision, to the close cooperation with data management teams allows me to understand the interactions between teams and the flow of tasks and decisions.

My main interest in the challenging and interesting field of clinical research is dedicated to the quality of work on site and to the interaction between the people involved in it. Close and long lasting co-operations with investigators and study nurses, as well as with CRA colleagues, project managers, data managers and others helped me to identify the most demanding tasks, pitfalls and the ways to avoid or reduce risks.

 

Apart from my own work as CRA I offer support as a co-monitor. The essential aspect of this work is the active involvement of the site CRA in the definition of corrective actions and their follow up, in combination with training and coaching for a lasting benefit. This ‘real life’ training on GCP aspects as well as on soft skills and on the organization of working time and working place has proven to be a useful approach.

As an intensification of the above I offer site audit services.

As freelance based in the city of Aachen I am working on my own with logistical and IT support for tasks in the office if needed.
In case of clients' requests for larger capacities I have the possibility to recommend freelance colleagues who are well known to me. No subcontracting will be done by me.

I would like to invite you to have a closer look at my background and the services offered.

For a shortcut please feel free contact me directly via phone 0049 171 28 44 299 or andrea@plum.ac

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