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.
Realizing this need, over the past year, Florence joined forces with vendors and research Sites around the globe to develop the MAGI eISF Reference Model. Now in the final peer review stages, this reference model will be released early February 2020.
The eISF Reference Model maximizes benefits to the research Site, streamlines collaboration between Sponsor/CRO stakeholders, and allows Sites the freedom to select an eISF platform that best fits their needs.
In other words, this effort to bridge the functional and structural differences between eClinical technologies will reinforce the collaboration trends and offer consistency – without squelching workflows unique to each organization.
Six Benefits of an eISF Reference Model:
1) Enhance Document and Data Exchange Between Cooperating Sites
As each research organization selects and invests in the platform that best suits their needs, it is essential that those eISF platforms can connect to and exchange documents with one another.
By having similar document and data structures, regardless of the eISF platform a Site chooses to deploy, the Site can ensure that they can collaborate in real-time with other participating Sites.
This exchange mechanism removes barriers in multi-center research that typically slow progress, such as the need to manually download, upload, and sort files.
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. So, when a Site has chained themselves to a specific eTMF vendor’s eISF/eRegulatory add-on, they risk the inability to exchange documents and data with other Sponsor organizations.
An 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 a major eTMF add-on tool.
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.
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.
Also, this standard document and data model helps 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, eTMF add-on tools designed for Sponsors but pushed on Sites, as well as email/paper exchange. However, it is essential CRAs are able to easily navigate and work within the eISF.
By removing guesswork as to where common artifacts or documents are stored through the eISF Reference Model, 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 quickly answer questions and provide clear records of document storage.
6) Enable Integrations with Current and Future Systems
The eISF 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 the ways in which 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. In fact, 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.