Advarra survey - use of sponosr tech greatest burden faced by sites

05-Jun-2024 - Last updated on 05-Jun-2024 at 09:53 GMT

As DIA's 60th anniversary at the annual event in San Diego approaches, OSP is excited to bring you insights from Advarra, a leader in advancing clinical research.

Advarra is set to reveal solutions tailored to address current challenges in the pharmaceutical and healthcare industries. With the results from the 2023 Advarra Site Survey highlighting the burden of training and use of sponsor technology on sites, it is putting forward solutions such as single sign-on and integrated technology ecosystems to streamline study start-up processes.

Additionally, Advarra is navigating the evolving regulatory landscape with a focus on centralized IRB review, which aims to reduce administrative burdens and promote consistent study conduct across sites. Looking ahead, it identifies key trends shaping the future of the pharmaceutical industry, including driving efficiencies through innovative technology, and enhancing user experience for sites and patients. Join us as we explore these innovations and Advarra’s strategic vision for the future.

Can you share any new products or services your company is unveiling at this year’s DIA and how do your latest innovations address current challenges in the pharmaceutical and healthcare industries?

Results from the site survey suggest that training and use of sponsor technology is the greatest burden faced by sites in study start-up and that this burden has increased over the past five years. Discussions with site customers also suggest that the technology burden is due to several factors, including the number of different systems/logins including one with 23 for an oncology study and need for duplicate activities between site and sponsor technology. The path forward is enabling sites to log-on with their own credentials, a single sign-on, and by continuing to connect the technology ecosystem for user, document, and data flow.

How are you navigating the evolving regulatory landscape in the pharmaceutical industry and what steps is your company taking to ensure compliance with the latest global regulatory requirements?

The single institutional review board mandate became effective in 2018 for NIH-funded research and the proposed rule will impact the remainder of non-federally funded research and ultimately nearly all multisite research conducted in the US. Centralized IRB review will have many downstream effects, but perhaps the greatest impact is the potential for reducing administrative burden on investigators, sites, and sponsors. It also promotes consistent study conduct across all sites, which in turn will produce more reliable data. Collectively, these benefits have the benefit of significant operational efficiencies when sponsors no longer must navigate multiple IRBs selected by the participating institutions. Advarra is leading the industry in helping sponsor and site organizations navigate this change. Most recently with the NIAID award to provide SIRB services to the NIH.

What major trends do you see shaping the future of the pharmaceutical industry?

From a technology perspective, the pharmaceutical industry will be increasingly challenged to drive efficiencies, including justifying return on investment for R&D technology not only for internal teams, but also for sites and patients. Prioritizing site and patient user experience, standardizing on a single cross-study configuration, and simplifying procurement through vendor consolidation will all be important areas of focus for the industry in 2025 and beyond. In response, we have begun to see pharmaceutical companies’ question ‘the way we have always done it,’ and instead considering newer tools such as Advarra’s Longboat that integrate more seamlessly with the site’s technology of choice, are easier to use, and consolidate multiple point solutions.