Doris Breiner, MSc Consultant Clinical Research works since 2005 in the field of clinical research. In the meantime the focus was set on the quality aspects to ensure robust and reliable data to go online with the regulatory requirements with regards to the data integrity.
The first edition of the practical guide related to the topic The Duty for Sponsor Oversight in Clinical Research outlined the underlying requirements as well as possible approaches to implement it efficiently in small and mid-sized companies. This was based on a master's thesis...
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