Florence’s Compliance team has reviewed Health Canada regulations and confirmed that the use of electronic systems such as Florence is compliant with Health Canada requirements.

The Compliance Team also did a thorough review of privacy regulations at both the national and local level, we see no concerns being used in compliance with Canada’s PIPEDA or province specific regulations.

Key takeaways from our review of Regulations in Canada:

• Sponsors are ultimately responsible for all aspects of the clinical trials they initiate in Canada, including any electronic systems used in those trials.
• Electronic Signatures were already used prior to Covid-19, however the pandemic accelerated use of these approaches. Florence meets the recommended technical controls to ensure the signature belongs to the user who applied it.
• The use of any electronic system must be fully validated for their intended use and supported by documented procedures and the appropriate training.