Novartis, you can now connect to your research sites eISF in real-time for remote study start-up and monitoring.

 Florence eHub is an advanced site portal that empowers clinical trial sponsors and CROs by directly connecting them to their research sites for real-time access, automated eTMF-eISF document exchange, and advanced analytics.

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We can help Novartis join leading sponsors and CROs using Florence eHub for better clinical trial site operations, analytics, and oversight.

Built on the digitally connected network of 5,000+ Investigators managing eRegulatory and eSource in Florence eBinders, Florence eHub provides sponsors and CROs real-time site access, advanced remote monitoring capabilities, automated eTMF document exchange, and views of hidden operational analytics for better study site performance.

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How does Florence eHub work?

Integrate your eTMF with Site eISFs

Eliminate the need for mailing, emailing, and faxing study documents by directly integrating your eTMF with your sites eISF

  • Deploy a fully functioning Electronic Investigator Site File (eISF) to all sites

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

  • Exchange documents with a single site, or all of your sites, in one click.

  • Fully compliant for the site and the sponsor with granular access controls

Enable Real-Time Site Oversight

Comply with GCP IH6 V2 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

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

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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Connect with our team to discover how Novartis can harness Florence eHub to directly connect with Research Sites.

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