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Essential Information

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Key resources on clinical trial compliance, including FDA guidance, GDPR, HIPAA, and ICH GCP E6 (R3) requirements.
Privacy, Data Protection, and Compliance | Florence
florencehc.com
Privacy, Data Protection, and Compliance | Florence

When it comes to data protection, Florence’s commitment to personal data privacy and security goes above and beyond.

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Florence Healthcare
Library of FDA Guidance for Electronic Document Management
florencehc.com
Library of FDA Guidance for Electronic Document Management

The Florence library of the FDA's responses to GCP inquiries regarding electronic processes in clinical investigations, like ICH guidelines for case report forms and FDA guidance on wet ink signatures.

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Florence Healthcare
Compliance, A Shared Responsibility Model - Florence
florencehc.com
Compliance, A Shared Responsibility Model - Florence

Compliance is a shared responsibility between Florence and our customers. Florence interprets the technical and procedural requirements of applicable global regulations so that our customers can have time back in their day to focus on research.

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Florence Healthcare
21 CFR Part 11 - FDA Requirements for Electronic Records
florencehc.com
21 CFR Part 11 - FDA Requirements for Electronic Records

Guidance on FDA Title 21 CFR Part 11 regulations for electronic documentation and electronic signatures and how it impacts Clinical Trials.

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Florence Healthcare
ICH GCP E6 (R3) Good Clinical Practice Guidelines
florencehc.com
ICH GCP E6 (R3) Good Clinical Practice Guidelines

ICH GCP E6 R3 guidelines outlining the significant implications for clinical trial sponsor and site technology and document management.

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Florence Healthcare
GDPR and Clinical Trials: Impact, Resources, and Q&A
florencehc.com
GDPR and Clinical Trials: Impact, Resources, and Q&A

Learn what you need to know about GDPR and clinical trials. All information is sourced from official GDPR documentation and outlined in an easy-to-use format.

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Florence Healthcare
HIPAA, Clinical Trials and Technology | FAQ - Florence
florencehc.com
HIPAA, Clinical Trials and Technology | FAQ - Florence

This FAQ page provides essential information about HIPAA regulations as they relate to clinical trials and the use of technology. Florence offers insights into how their platform facilitates compliance and enhances remote connectivity in clinical research.

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Florence Healthcare
Florence FAQs - Florence
florencehc.com
Florence FAQs - Florence

Explore frequently asked questions about Florence’s Site Enablement Platform. Discover tailored pricing and support options designed to meet the unique needs of your organization.

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Florence Healthcare
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