Our mission at Forte is to transform clinical research with a site-centric approach. Through our array of products and services, we attempt to fulfill that mission in many different ways. As the former product manager of the Forte eRegulatory Management System, my key focus was to collaborate with our Onsemble Customer Community to create an eReg solution that not only streamlined their day-to-day regulatory management, but created new efficiencies across the entire clinical research industry.
While we’re still working toward achieving those lofty goals, we’re fortunate to have learned a lot from our collaborators. Early in the process, the group identified multi-site regulatory management as a key challenge among large academic research centers ripe for technological efficiencies. Often, these organizations act as the coordinating center for investigator-initiated trials, not only conducting research at their site, but managing participating sites as well. Those familiar with regulatory management know that exchanging documents through mail and email is a challenge for any study. For centers managing regulatory documents across multiple sites, it can become a significant burden, affecting study activation timelines, resource planning and even regulatory compliance itself.
As we dissected this problem of multi-site management, we posed a question to our collaborators: what does multi-site regulatory management mean to you? In addition to finding common threads within their responses, we looked at how others in the industry have addressed the issue. We found that the primary solution was allowing participating sites to log into the regulatory management system in the same way as those at the coordinating center. While permissions could be limited for users at participating sites, this method didn’t provide the control that coordinating centers were looking for to ensure that documents were properly accessed and organized. These systems fit the need for centers managing sites within their own network (where access and permissions were less of a concern), but they didn’t provide the security needed for centers coordinating studies and sites across the country.
As we explored additional multi site regulatory management meanings with our customers, we uncovered common concerns that span across regulatory management as a whole: reducing compliance risk, standardizing processes and organization and improving efficiency for regulatory teams. This helped guide us towards our eventual solution, which aims to eliminate cumbersome mail/email document sharing, improve efficiency and compliance for regulatory staff and minimize the number of regulatory-focused systems that site staff interact with. The approach also adheres to a trial master file (TMF) that standardizes the data structure across sites and studies, making binders more consistent and compliant.
As you can see in the diagram below, our collaborators stressed the need for workflows accommodating all sites (whether or not they license the Forte eReg system) while providing additional functionality when both the coordinating center and the participating site use Forte eReg. Participating sites without eReg receive an invitation to the system, which then allows them to upload signed documents. These arrive in an inbox within the coordinating center’s system, allowing the regulatory manager to properly file the documents. This provides easy electronic workflows for participating sites, while allowing coordinating centers the control they desire to maintain compliance.
When both the coordinating center and participating site use eReg, their systems can be linked via a coordinating center invitation. This unlocks unprecedented efficiencies by allowing additional document checklists, protocol docs and more to be exchanged between the systems. This allows both sites to coordinate/participate in a trial without leaving their eReg system.
While we have presented this within the structure of an investigator-initiated trial, the foundation we’ve built will soon also accommodate data exchange between sites and sponsors. Forte’s Trial Data Exchange initiative is driving an inversion of focus to the sites that allows regulatory documents stored in the investigator site file (ISF) to be instantly exchanged to the sponsor/CRO trial master file (TMF) after review, approval, and electronic signature is received from the research organization’s eReg system.
This exemplifies our philosophy for Trial Data Exchange, creating a connected clinical trial ecosystem to address the challenges of conducting multi-site trials. In addition to connecting regulatory stakeholders within the industry, Trial Data Exchange is also focused on similar data exchange workflows for operational data (including providing sites with protocol documents, draft budgets and coverage analyses) and electronic case report form (eCRF) data.
If your site conducts or participates in multi-site trials, Forte eReg can help create more efficient, compliant workflows for your regulatory teams.