The eISF Reference Model is the industry standard for setting up and managing an Electronic Investigator Site File designed by all of the major eISF vendors, along with research sites and sponsors.

The Electronic Investigator Site File (eISF) is projected to be in use at over 61% of clinical research Sites by the end of 2020, according to a recent Florence State of the Industry Report. 

At the same time, clinical trials continue to become increasingly collaborative – especially with the rise of multi-center trials that require various research Sites across different organizations to work together.  

The rise in the eISF, coupled with an increasing need for real-time collaboration and document exchange among Sites and Sponsors/CROs, mandates the need for an eISF Reference Model. 

Our dedication to collaboration with other eISF vendors, instead of developing an independent model, is in the spirit of advancing research together that is required to accelerate cures reaching patients. Sites have the freedom to select the eISF platform that best fits their needs without fear they will cut off collaboration opportunities with external stakeholders.

This Industry-Standard eISF Reference Model maximizes benefits to the research Site and streamlines collaboration between Sponsor/CRO stakeholders.  

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Six Benefits of an eISF Reference Model: 

1) Ease the Transition from Paper Binders to the eISF

A modern eISF like Florence eBinders introduces features like document routing, global searches, and advanced tagging – all to facilitate easier management of study documents.

However, it is no secret the clinical trial industry is in flux, and expecting established research teams who built their processes around paper to be comfortable immediately transitioning to automated solutions is in error. In essence, it would be like plucking someone from 1800 and expecting them to drive a Formula 1 race car quickly.

Instead, the eISF Reference Model eases this transition by closely aligning with the checklists and folder structures the research site teams are expecting and trained to use. Florence eBinders maximizes the benefits of a modern eISF for the research site, while also being aware of the transformation timeline that must take place.

As with any change, easing the organization into it instead of simply throwing away the old, is the only way to see a transformation.

2) Streamline Document and Data Exchange with any Sponsor eTMF

While an eISF/eRegulatory add-on to the eTMF sounds attractive, especially if it’s free, this approach doesn’t work. Each Sponsor uses a different eTMF. When a Site has chained themselves to a specific eTMF vendor’s eISF add-on they risk the inability to exchange documents and data with other Sponsor organizations.

An industry-standard eISF Reference Model instead allows the Site to select a best-in-class eISF platform and exchange those documents with any Sponsor’s eTMF through Open APIs – instead of being locked into an eTMF add-on afterthought.

This capability also reinforces the Site’s ability to ask the Sponsor to cover the cost of their eISF because of the value gained from ease-of-use and time-saving features.

Understanding eTMF – eISF Integration

3) Accelerate Study Startup

Study startup is one of the most critical times during the course of a clinical trial. Driving document structure consistency relevant to Study Startup will lead to faster creation, organization, and management of clinical studies.

Industry-standard document and data models like the eISF Reference Model help to get new team members up-to-speed quickly – whether they are joining from another internal group or a different organization.

4) Simplify CRA Training for Monitoring Visits

The eISF eliminates the need for eTMF Site Portals as well as email/paper exchange. However, CRAs must be able to navigate and work within the eISF efficiently.

Structuring documents on an eISF Reference Model removes guesswork as to where common artifacts or documents are stored so the CRA can navigate and complete his or her duties in a more timely and efficient manner.

The eISF Reference Model, coupled with advanced eISF features like built-in monitor review functionality and eTMF integrations, transforms the monitoring visit – greatly reducing the burden on the Site and the Sponsor.

5) Increase Audit Readiness

A fully-automated document organization platform runs the risk of creating critical compliance mistakes, as a human is unable to appropriately track where the system placed a document, and why.

Instead, eISF technology must offer intelligent assistance for completing document workflows. The eISF Reference Model enables standardized document structures that, once in place, a system can quickly reference while maintaining visibility for the research team.

This standardization, coupled with intelligent software assistance, ensure when the FDA or other governing body arrives for an inspection, the clinical research team is ready to answer questions and provide clear records of document storage quickly.

6) Enable Integrations with Current and Future Systems

The eISF Reference Model enables structured data, which in turn supports current and future integrations with other best-in-class systems.

Auto-filling, auto-naming, and other features standard in off-the-shelf platforms lock the research site into only using that tool for more advanced functionality. Research sites utilizing these type platforms run the risk of isolating themselves from future innovations.

Additionally, this standard data structure, coupled with an Open API infrastructure, allows for easy integrations between existing systems like the CTMS.

The rise of the eISF born from increased need for collaboration and optimization of Site workflows, coupled with the eISF Reference Model, is another example of how Sites are scaling and leading innovation based on their needs.

Sites that don’t have an eISF in place are at risk of losing leading trials and being overlooked by Sponsors. Leading Sponsors as well as multi-site trial coordinating centers in the process of selecting Sites, now come to Florence to find out which are using the eBinders platform.

To learn more about the eISF Reference Model, or to see a sneak peek of the Florence eBinders platform, connect with us today.


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