Florence’s Compliance Team has reviewed regulations set forth by the Medicines and Healthcare products Regulatory Agency (MHRA) and confirmed that the use of electronic systems such as Florence is compliant with United Kingdom (UK) requirements. 

Florence complies with numerous regulations within the UK, which directly facilitate the use of Florence across various areas, including electronic document management, electronic signatures, remote monitoring, and remote source data verification.

  • MHRA Good Clinical Practice Guide

  • “GxP” Data Integrity Guidance 

  • UK MHRA TMF Q&A

  • Guidance on Access to Electronic Health Records by Sponsor representatives in clinical trials

  • Joint statement on seeking consent by electronic methods

GDPR Compliance

Florence is compliant with The Data Protection Act 2018, and utilizes 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 additionally adheres to the Caldicott Principles and is active under the UK Extension to the EU-U.S. Data Privacy Framework to provide adequate data protection.  

Refer to our privacy policy for additional information. 

NHS Support

For customers and prospects in the National Health Service (NHS), Florence has completed the Digital Technology Assessment Criteria (DTAC) to ensure our Site Enablement Platform meets the assessment criteria. 

Additionally, Florence has completed a Data Security and Protection Toolkit self-assessment to demonstrate we are practicing good data security and that personal information is handled correctly.

Additional Resources

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

  • User acceptance testing validation templates

  • Shared responsibility model

  • SOP templates

  • Full listing of regulations Florence complies with globally

Trusted by Sponsors & CROs, Loved by Sites

If you have any questions on how Florence’s Site Enablement Platform can support your UK Compliance needs, reach out to your Florence contact or schedule a demo.