Streamline Sponsor – Site Digital Collaboration

Accelerate your research with the only native Shared Investigator Platform (SIP) and Site eISF integration.

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Streamline your clinical operations with a native SIP connection to the largest eISF network in research, Florence, now hosting over 8,500 study site eISFs in 30+ countries.

Together, Florence and SIP deliver a site-first integrated digital experience through their strategic relationship and exclusive native integration.

The SIP eISF Connect module automates the flow of documents between the sponsor eTMF systems and Florence eBinders, the leading electronic Investigator Site File System (eISF), while enabling remote site access for monitoring and SDR/V. 

Learn how you can take advantage of this native integration today.

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Accelerate startup with site-initiated workflows

  • Send startup documents to sites in one click.
  • Empower sites to initiate and take charge of start-up tasks.
  • Exchange documents at the push of a button.
  • Repeat study setup structures for future studies.

Turn on remote site monitoring and source access

  • Gain instant access to 8,500+ study sites on Florence.
  • Provide new sites a fully functioning and industry-trusted eISF space.
  • Remotely access study sites’ source data for SDR.

Reduce compliance risks with site-controlled processes

  • Enable sites to maintain ICH-mandated control of documents.
  • Sync document status updates and digital audit trails.
  • Create permission-based and site-managed access for roles.

Simplify site adoption with the Florence approach

  • Drive site adoption with Florence’s proven processes.
  • Enjoy proven 92%+ site technology adoption rates.
  • Benefit from dedicated training and support for you and your sites.
  • Connect to 8,500+ existing study sites on Florence.

Reduce points of friction and hand-off delays

  • Navigate from SIP to Florence eISF in-platform.
  • Standardize study structures across sites.
  • Streamline workflows and data mapping across sites.

Build a future proof technology foundation

  • Entrust in Florence and Cognizant as your partners for the future.
  • Build on native integrations that power future collaboration.

How does the SIP to Florence integration work?

eHUB Publisher

Integrate your eTMF Structure with Site eISFs

Eliminate the need for mailing, emailing, and faxing study documents, and legacy site upload portals, by directly integrating your eTMF structure with your sites’ eISF.

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

  • Standardize eTMF file structures directly through Florence eHub with 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 ICH GCP E6(R2) requirements for site oversight

  • Be alerted of potential compliance risks earlier with real-time monitoring in the eISF.

  • Track study startup against predetermined milestones.

  • Communicate with sites directly, assign tasks, and access study documents instantly.

Florence eHub - Clinical Trial Site Oversight
Florence eHub - Clinical Trial Site Oversight 2

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.

Task Creation eBinders
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 risks across your study sites and add more value.

  • 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 in both SIP and Florence eBinders.

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

Florence eTMF eHub Sponsor Document Approval
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