Donatella began her career in the pharmaceutical industry 12 years ago in Global Clinical Development at Chiesi Farmaceutici where she managed Late Phase Clinical Trials on Neonatology and Rare Disease, focusing on clinical documentation management. As Document & Training Manager, Donatella implemented documentation management processes in the department and served as the leading ambassador to move from paper to an electronic Trial Master File. In 2020 she became Head of the GCP Compliance and Clinical Trial Administration Unit in Chiesi Farmaceutici. The scope of the Unit was to ensure the compliance of all the Clinical Operation Processes with ICH-GCP as well as to guarantee a continuous Inspection Readiness of the TMF. Her expertise and passion for TMF have now led her to become Head of eTMF Services at Montrium.
The TMF is the backbone of clinical trials, and keeping it in tip-top shape is crucial for inspection readiness.
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