Florence Compliance, Security, and Data Protection

You’re trusting us with a core component of your operations, and Florence takes this seriously. We’re committed to your success in advancing research together: in a compliant, safe, and secure way.

Florence has implemented rigorous privacy and security measures to ensure adherence to the highest standards of compliance. Access comprehensive guides, checklists, and country-specific resources on our global compliance commitment—all in one place.

Global Insights & Resources

20k

Sites

90+

Countries

7.2M

Monthly workflows

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GLOBAL REGULATIONS

Manage Global Studies, Compliantly

At Florence, our Global Compliance Team assesses country-specific clinical regulations to ascertain our service capabilities for sites and sponsors worldwide. We support clinical trial operations in over 90 countries, facilitating compliant workflows for eISF/eTMF, eConsent, electronic signatures, remote monitoring, source data verification, and more.

With your typical use cases of Florence products in mind, the Compliance Team evaluates regulations to aid in simplifying global expansion.

RESOURCES

SOFTWARE COMPLIANCE

Florence Supports your Compliance

Florence has done the regulatory heavy lifting as it relates to understanding and interpreting the technical and procedural requirements so that you can have time back in your day to focus on research. The Florence Compliance team works closely with our Software Development teams to ensure we uphold our compliance commitment with each release. 

Florence is compliant with the technical requirements of 21 CFR Part 11, Annex 11, ICH GCP and more. Compliance is a shared responsibility between Florence and our customers. Florence maintains a Shared Responsibility Model to ensure the technical and procedural requirements of applicable global regulations are understood. 

RESOURCES

DATA PRIVACY

Keeping your Data Safe

At Florence, our Global Compliance team is on top of the evolving privacy landscape. Florence has not only taken the necessary steps to self-certify compliance with General Data Protection Regulation (GDPR), it is written into our company’s culture and the basis for our data privacy procedures. Florence is approved under EU-U.S. Data Privacy Framework (DPF), along with the UK Extension to the EU-U.S. DPF, and the Swiss-U.S DPF; demonstrating our commitment to adequate data protection.

Personal data privacy is of the utmost importance to us. You have the right to know how your information is collected and used. The Florence Privacy Policy was designed to protect your research study data, including any and all individuals whose personal data is handled by Florence; this includes the personal data of our software users, account holders, research team members, and research participants. The Privacy Policy describes our policies and practices regarding the collection, use, disclosure, and processing of your personal information. It also describes your rights and choices regarding your personal information.

RESOURCES

SECURITY

Securing your Workflows

Protecting customer data is of the utmost importance to Florence and is built into every aspect of our service. We align our security practices with industry guidance including NIST, and we have a robust library of security policies and procedures in place to formalize and govern our security practices. Florence also has a third-party SOC 2 attestation performed annually not only to ensure we are meeting industry standards and best practices but to demonstrate our commitment to security and give our customers peace of mind regarding the security of their valuable data. Our SOC 2 Type 2 Report is available for customers to review upon request.

RESOURCES

“Florence cultivates collaborative Compliance. At Florence we believe in shared responsibility because we recognize we all play a significant role in protecting customers’ and study participants’ data and privacy. Florence does extensive research into global regulations affecting clinical trial documentation, monitoring, data transfer and storage. Armed with that information, we can provide solid guidance to our customers so that they can best leverage the Florence resources towards critical clinical trials in their global venues.”

Nancy DiGioacchino
VP, Quality Management & Global Compliance

Questions about Compliance, Security, or Data Protection?

Still have unanswered questions?

We are committed to building trust, ensuring compliance, and enhancing operational efficiency.

To access confidential information not featured on this page, such as our detailed SOC 2 Type II reports, a signed NDA is required.

Please read and sign Florence’s NDA to gain access to our compliance portal.