Florence’s Compliance Team has reviewed the regulations established by the Therapeutic Goods Administration (TGA) and confirmed that the use of electronic systems, such as Florence, complies with Australian requirements.

This encompasses adherence to a broad range of regulations within Australia, specifically those supporting its application in areas such as electronic document management, electronic signatures, remote monitoring, and remote source data verification.

Teletrials

National Standard Operating Procedures for Clinical Trials including Teletrials in Australia

ICH Guidelines

for Good Clinical Practice, as annotated with TGA comments for implementation in Australia

Manage + Monitor

Risk-based management and monitoring of Clinical Trials involving therapeutic goods

Privacy Considerations

Florenceā€™s Site Enablement Platform can be used in compliance with Privacy Act 1988, Australian Privacy Principles Guidelines and My Health Records Privacy Act 2012.

For customers and prospects looking to utilize Florence for health data, reach out to your Florence contact for additional information on how we meet the data localization requirements to store it in a compliant manner!

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

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