Building a Foundation for Regulatory Success in the Post-Pandemic Landscape
The past year has been one of the most challenging ever for those working in healthcare and clinical research. The industry faces unprecedented obstacles as we navigated the dual challenge of developing a COVID-19 vaccine. At the same time, also keep research moving forward in other areas. As we begin to emerge from the pandemic, we see that the research landscape has fundamentally changed. The past year has shifted the focus of sponsors, CROs, and research sites to improve in critical areas, including:
- Access to research for diverse and underserved communities
- Education of the general public on the efficacy and safety of new treatments
- Standardization of data and process across the industry
- Adoption of enterprise technology
While some focus areas above are long-term challenges requiring joint effort across the industry, technology adoption can be a quick win for organizations looking to improve processes, cut costs, and adapt to remote workflows. At Advarra’s recent 2021 Spring Onsemble Conference, a longtime customer lamented his organization’s lack of an effective eRegulatory (eReg) solution as his team faced the pandemic. “We desperately need an electronic document management system,” he said. “There are things that we haven’t been able to do as efficiently or effectively as we needed to, and that’s something we need to address quickly.” His organization is not alone. As your site looks to address this fundamental need moving forward, here are four ways an eReg system can increase productivity, improve compliance, and ensure a solid return on your technology investment.
4 Ways an eReg System Ensures Regulatory Success
1. Enterprise Integrations
Staff productivity and data quality are critical priorities for any regulatory team. By integrating your eReg solution with enterprise technology such as your eIRB system, clinical trial management system, emails (and corresponding attachments), and even other eReg systems, you can ensure a more efficient and compliant trial.
2. Remote Capabilities
With research staff forced to work from home and on-site monitoring halted, remote regulatory workflows have quickly become a necessity. As a centralized hub for regulatory documents and activities, a full-featured eReg system can be a vital resource to keep your team on track and provide visibility into the regulatory components of a trial. It can also facilitate remote monitoring by safely and securely granting access to monitors. A system such as Advarra eReg allows monitors to view only the essential documents they need to see on a site visit and only during the time specified by your site.
3. Master Delegation of Authority Workflows
For institutions managing a large volume of trials, a master delegation of authority can be a great solution to streamline the study activation process and minimize the burden on regulatory teams. However, standardizing staff delegation across multiple studies can be challenging without technology to manage the delegation process and electronic signatures. An eReg management system can help your organization manage an electronic master delegation of authority log, simplifying the delegation process and dramatically reducing the amount of time spent routing documents.
4. 21 CFR Part 11-compliant Routing, Signatures, and Document Management
At the foundation of any eReg management system is the management of your essential protocol documents. The ability to store protocol documents, efficiently route them for electronic signature, as well as track owners and expiration dates are critical components of an eReg solution.
The Advarra eRegulatory Management System provides all of the functionality above and has been developed through years of collaboration with dozens of leading academic medical centers, cancer centers, and health systems. This means it not only helps your institution become more efficient and compliant, but it also leverages the expertise of top organizations to help you build successful, centralized, and sustainable regulatory processes across all your trials.
To learn more about Advarra eReg, attend our two-part open demo series. Our first demo will focus on how eReg provides a comprehensive solution to boost productivity and compliance, taking a deep dive into many of the areas above. In the following demo, our team will discuss the future of eRegulatory management. Highlights will include:
- Upcoming eReg functionality enabling additional remote workflows
- Integrating across your technology ecosystem
- Further centralizing your regulatory management and much more.