Sponsor – Site Connectivity:

The End of the Clinical Trial Site Portal

Relying on Clinical Trial Site Portals to exchange critical documents delays studies, increases compliance risk, and reduces TMF completeness. Sponsors and CRs solve this problem by directly integrating with research site eISFs.

Discover which of the research sites you conduct studies at already have their eISF digitally connected to Florence eHub.

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52% of Sponsors/CROs Expect to be Fully Connected Digitally to their Sites by 2021.

Rising clinical trial complexity requires Sponsors/CROs to have direct connectivity with research sites to accelerate studies, reduce development costs, and ensure regulatory compliance.

eTMF and eISF Connections

To Meet this Demand Sponsors/CROs Often Deploy Clinical Trial Portals to Their Research Sites.

The response to this demand for site connectivity is often the deployment of “Site-Portals” to exchange critical study documents with research sites. A clinical trial portal (also known as clinical portal or clinical study portal) is a web portal or enterprise portal that primarily serves sponsors and investigators in a clinical trial.

A clinical portal is typically developed by a sponsor or CRO to facilitate centralized access to relevant information, documentation and online applications by investigational sites participating (or considering participation) in a trial, as well as for the monitors, study managers, data managers, medical, safety and regulatory staff that help plan, conduct, manage and review the trial.

Clinical Trial Portals add Stress to Research Sites and Rarely Deliver the Full Benefits Expected.

Because the average research organization conducts trials for dozens of Sponsors/CROs, sites are required to manage dozens of different portals resulting in poor performance and little added benefit to either the site or the sponsor.

“The answer to site connectivity is not clinical trial portals, it is integrating with research site infrastructure through the eISF.”

Discover which of the research sites you conduct studies at are already digitally connected to Florence eHub.

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Research Sites Now Deploy Electronic Investigator Site Files (eISF) to Manage all of Their Studies Electronically.

Leading research sites are now investing in site-based infrastructure, the eISF, to manage all of the documentation for their clinical trials.

These centralized systems allow research sites to maximize efficiency by integrating with existing systems, having one system to learn, and deploying unified workflows and processes for all studies.

Over 5,000 Global Research Teams now use Florence eISF to manage all of their study documents.

To Accelerate Research, Sponsors/CROs Must Connect Directly to Research Site eISFs

Instead of deploying unique site-portals to the research site, Sponsors/CROs must connect to the existing site eISF (or deploy a site-centric eISF).

Benefits of Direct Site eISF Integration:

Site Usability

Research sites work in a platform they are familiar with and are customized to their unique workfows.

Accelerate Clinical Research Study Startup

40% Faster Documents

Integrating the eTMF with the eISF automated the document exchange process for all sites.

Remote Access

Remote access for full remote monitoring – reducing interim monitoring visits by 65%

Florence eHub is Directly Connected to Over 5,000 Research Team eISF Platforms

Florence eHub is the only connectivity platform that connects the Sponsor/CRO eTMF directly to the Research Site eISF. Sponsors/CROs gain advanced site operational analytics, remote monitoring capabilities, and document/data exchange features.

Get connected to find out which of your sites are already integrated with Florence eHub.

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Learn about Florence eHub

Join leading sponsors and CROs using Florence eHub for better clinical trial site start-up, document exchange, 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 start-up activitation and 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, and legacy site upload portals, 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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