The Beginner’s Guide to Implementing an Enterprise eRegulatory Management System

Ryan Monte
Senior Product Marketing Manager, Forte
November 7th, 2019

An eRegulatory management system can provide substantial return on investment (ROI) for clinical research institutions, improving compliance and staff efficiency, reducing physical space requirements, streamlining processes, and more. For large institutions, system selection and implementation can be a lengthy, difficult-to-navigate process, especially when moving from a paper regulatory process. As a result, operational leadership can sometimes feel pressure to prioritize a quick timeline over a more comprehensive implementation that truly addresses their long-term needs. To make sure your organization reaches its true potential, it’s important to understand the benefits and limitations of each system you evaluate, and weigh those against your current and future goals.

Benefits of an Enterprise System

Your institution likely uses a wide array of enterprise systems for day-to-day operational and clinical tasks. These systems often include benefits such as institution-wide visibility into research, subjects and financials; system-level efficiencies that streamline processes across teams; and integration with other enterprise systems to eliminate duplicate data entry and enhance data quality.

When evaluating eRegulatory systems, it’s important to make sure your team chooses one suited for your size and research volume. A small community-based site or health system may not need enterprise-level functionality, while a larger organization may benefit from features like system-level protocol templates, integrations with a clinical trial management system (CTMS) and multi-site regulatory management, to name a few.

Varying Approaches to Implementation

A vendor offering “free” or pay-as-you-go systems implementing into one protocol or one team at a time may seem enticing. These trial periods appear to offer a low-risk entry point into the eRegulatory space. For the smaller organizations noted above, this approach may provide a valuable use case for the eRegulatory system, as you may not need to extend it beyond a few users or protocols.

For larger institutions such as academic medical centers, cancer centers and large health systems, this approach is often problematic. Because much of the inherent value of an enterprise-level eReg system is in the efficiency, compliance and ROI associated with a large volume of users and protocols, it can be difficult to adequately assess a system with heavily limited protocols and users. Key features such as integrations, enterprise reporting and master delegation of authority won’t be available, limiting the system’s effectiveness and making it difficult to establish buy-in from organizational stakeholders. As a result, these systems tend to be used long-term only for the small number of users and protocols they start with.

Another frequent issue, especially with free or low-cost systems, is the need to upgrade to utilize necessary features such as reporting, single sign-on and user privileges. Some systems even limit document retention, putting your documents at risk unless you upgrade within a specific time period. If the initial price point of a system seems too good to be true, you will want to clarify exactly what features are included to avoid issues down the road.

What to Look For in an Enterprise Vendor

Several vendor solutions, including the Forte eRegulatory Management System, are built specifically for enterprise use. These systems take into account institution-wide workflows and provide comprehensive resources for implementing across your research teams, including 21 CFR Part 11 validation and the migration of your current studies into the eReg system. They are designed to act as a single, centralized source of truth for all research within your organization, standardizing regulatory management across the institution and streamlining the regulatory process for your clinical, operational and regulatory staff.

To learn more about Forte’s eRegulatory Management System, join us for an open demo Thursday, December 12 at 1:00 pm Central. We’ll show how eReg provides integrated protocol, staff and institution documentation to boost regulatory compliance, productivity and ROI, all within a 21 CFR Part 11-compliant system. We’ll also demonstrate new multi-site regulatory management, allowing coordinating centers to manage essential documents for participating sites entirely within the eReg system. We hope you can join us!