Forte Announces eReg Updates to Support Regulatory Compliance


Applied Clinical Trials

Forte has announced significant updates to its eReg solution, which allows sites to compliantly manage multi-site trials. These additional eReg capabilities also serve as the foundation for the regulatory component of Forte's Trial Data Exchange, an open, secure collaboration and data sharing platform feature that gives sites and sponsors the ability to collaborate, share trial-specific data on demand, and structure necessary controls for access to regulatory, operational and clinical source data.

Developed in concert with academic research organizations-and eReg users-like Yale, The Ohio State University, and Karmanos Cancer Institute, eReg now offers multi-site trial management capabilities that will enable industry-wide research collaboration. Forte eReg customers are able to track and manage their investigator-initiated trials and streamline workflows across individual research sites more cohesively. Customers will now be able to maximize compliance, data security, and efficiency of their full portfolio of studies across all departments within an organization and collaborate with sponsors on data and trial progress.

James Wurdeman, Chief Product Officer at Forte, said, "Our commitment remains to arm the clinical research industry with secure, powerful and flexible technology. Today's eReg announcement is proof positive that important, game-changing progress is happening, and true industry-wide collaboration and compliance will become a reality in the near future."

Specific eReg features that have been added to Forte's platform include: 

  • Multi-site regulatory management for both sponsors and sites

  • Single-system essential document portfolio management capabilities across sponsored, IND/IDE held, and recruiting site clinical trials

  • Secure and compliant login processes that offer an easy, intuitive experience for participating sites

  • Workflows that create transparent and compliant trial data connections between site and sponsor

"Forte's eReg system is an integral part of our mission of a seamless clinical research management process. The system was built for the community, by the community, and we are thrilled to be one of the research institutions that collaborated to help build eReg from the ground up," said Robb Stillman, Director, Research & Clinical Informatics at The Ohio State University Wexner Medical Center, James Cancer Hospital and Solove Research Institute. "The implementation of eReg provides multifaceted benefits, including integration with Forte's OnCore Enterprise Research System, simplified document management and most importantly, increased compliance across our research portfolio. We're also thrilled for the addition of multi-site management-this will be a valuable addition for organizations like OSU, streamlining our compliance processes, reducing the burden for our regulatory staff and improving data quality across all the multi-site trials we coordinate."

Forte's new features will be available to all eReg customers in Q3.

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