PRIM&R AER Conference: Collaborating to Advance Ethical Research

Stuart Cotter
Director of Product Success, Forte
December 9th, 2019

Two weeks ago, my Forte colleagues and I attended the PRIM&R 2019 Advancing Ethical Research Conference in Boston, MA. The conference included renowned speakers from across the industry, highlighted exciting changes within the research community and provided an opportunity for me and my team to make new connections within the regulatory and compliance space. The camaraderie, collaboration and dedication to clinical trials was reminiscent of our own Onsemble Conference, with ample opportunity to learn, network and enjoy time with colleagues.

This was my first conference since our recent acquisition by Advarra, and attending alongside our new partners highlighted the impact we can make by combining research technology solutions, research compliance and human subject protection services. In addition to unifying our products and services to ease the burden on operational research staff, we can significantly impact study startup to get treatments to market faster.

As product manager for the Forte eRegulatory Management System, the conference also provided me a firsthand look at the day-to-day issues faced by staff working in human subjects protections, research ethics and oversight. Finding ways to address these issues through technology solutions is a key part of my job, and I’m encouraged by the engagement around creating insight into the study team documentation through an eRegulatory solution. The automatic filing and tracking of essential protocol documents, along with the management of delegation logs and staff training, can provide real-time oversight in ensuring the correct institutional and governmental procedures are being followed to best protect each participate on the clinical trial. With tracks including innovation in IRB/regulatory processes, the PRIM&R conference reflected the importance of creating systems and workflows to ensure the protection of human subjects in clinical research.

As clinical research becomes more diverse both in research subjects and research sites themselves, it’s important for technology to follow suit. Throughout the past year, our team has been working to develop new Forte eReg functionality to better facilitate multi-site trials and serve as a foundation for the regulatory component of our Trial Data Exchange. Our latest release will enable institutions to send their investigator site file documents to the sponsor coordinating center while using eReg. This efficiency allows users to bulk send the protocol staff credentials, Lab and IRB documents, and electronically-signed protocol documents with a click of a button rather than logging into sponsor portals, sending emails or granting access to local file systems. These additions, developed through collaboration with our customers and other industry stakeholders, will help usher in a new era of standardization and cooperation throughout the clinical research industry.

If you’d like to learn more about the Forte eRegulatory Management System, join us for an open demo Thursday, December 12 at 1:00 pm Central. We’ll show how an eRegulatory system provides integrated protocol, staff and institution documentation to boost regulatory compliance, productivity and return on investment. We’ll also cover the benefits of working with a single vendor for your research systems to ensure consistency for your staff and make the most of your system integrations. We hope you can join us!