Download: Four Essential Strategies for Complying with ICH GCP E6(R2)

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Learn how Florence eHub helps sponsors ensure ICH GCP E6(R2) compliance.

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Join pioneering sponsors and CROs using Florence eHub for better clinical trial site operations and analytics.

Built on the foundation of 3,000+ sites managing eRegulatory and eSource in Florence eBinders™, Florence eHub provides sponsors and CROs real-time site oversight capabilities, compliant document workflows, and access to hidden operational analytics for better study site performance.

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How does Florence eHub work?

Forecast Site Performance

Know where all of your sites stand with their startup and study progress in real-time.

  • Analyze historical site operational performance to forecast feasibility.

  • Forecast study startup time based on site historical performance.

  • Understand the mind-share your study is receiving at sites.

  • Remain aware of site inspection readiness.

Enable Real-Time Site Oversight

Comply with ICH GCP E6(R2) requirements for site oversight

  • Be alerted of potential compliance risks earlier.

  • Track study startup against predetermined milestones.

  • Communicate with sites directly and access study documents instantly.

Deliver Startup Documents to Sites

Eliminate the need for mailing, emailing, and faxing study start-up documents and protocols to research sites.

  • Build your study file structure in Florence eTMF (or your own eTMF).

  • Publish eTMF file structures directly into Florence eHub, a secure and compliant shared workspace for sites.

  • Send to a single site, or all of your sites, in one click.

  • Sites only see the files they are granted access to within their eISF.

Keep Sites on Track

Easily give CRAs the ability to assign tasks and specify deadlines for sites.

  • Assign tasks to each individual site or across the study.

  • Build project timelines delivering actionable insights into startup progress.

  • Sites notified of required documents in real-time.

Florence eTMF and eHub Dashboard

Monitor Site Progress and Source

Gain real-time insights into individual site, and study-wide, progress and source documents.

  • Global view of all of your sites status in one place.

  • Actionable insights into individual site progress.

  • Identify potential delays and compliance risk across your study sites.

  • Immediately respond to risk-based monitoring issues.

Quality Control Site Documents

Ensure document quality before syncing back with your eTMF structure.

  • Completed documents are held in queue until CRAs review.

  • CRA can reject file with comments, sending it back to sites for an update.

  • Review full audit trail of the document.

  • Approved documents are synced to the correct location within the eTMF.

Florence eTMF eHub Sponsor Document Approval

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