Florence’s Compliance Team has reviewed regulations set forth by the European Medicines Agency (EMA) and European Commission (EC) and confirmed that the use of electronic systems such as Florence is compliant with general EMA/EC requirements. 

Florence complies with numerous regulations within the European Union (EU) and the European Economic Area (EEA), which directly facilitate the use of Florence across various areas, including electronic document management, electronic signatures, remote monitoring, and remote source data verification.

Florence is compliant with the General Data Protection Regulation (GDPR) as the foundational basis for global privacy. If you are looking to understand how GDPR affects your clinical trial operations, refer to this guide. 

Florence is active under the EU-U.S. Data Privacy Framework (DPF), the UK Extension to the EU-U.S. DPF and the Swiss-U.S. DPF to provide adequate data protection.  

Refer to our privacy policy for additional information. 

When conducting research within the EU/EEA,  it is important to consider national provisions applicable in each Member State, which may be more stringent than those of the region as a whole. The Florence Compliance Team has looked into regulations in key member states to ensure that Florence can meet local regulatory and privacy requirements in addition to those of the EU/EEA as a whole.

Florence customers have access to additional resources to support their compliance efforts, reach out to your Florence contact for additional information!