eReg Adoption a Challenge for Sites, But Worth the Investment, Experts Say
Implementing an electronic regulatory (eReg) system can seem daunting to sites when it comes to the costs and time involved, but those that commit to it can reap multiple benefits, including faster study startup, increased efficiency and decreased long-term costs.
An eReg system that helps sites file, store and manage all of their trials’ regulatory documents can reduce costs and streamline operations, but these platforms should be interconnected with other site systems to fully harvest their benefits, Clare Grace, chief patient officer for Parexel, tells CenterWatch Weekly. Many sites’ hybrid approaches to eReg don’t communicate and share data with their other systems, such as electronic data capture and management programs.
“eReg systems are often different and vary from site to site, some with limited remote access and others that are not integrated into an electronic trial master file (eTMF),” Grace said. “Ideally, the goal is to have unified, connected systems that can streamline the way data is shared remotely and securely throughout the trial process.”
Sites may also be hesitant to move away from traditional, familiar approaches like paper, email and spreadsheets, but these approaches don’t maximize efficiency and can lead to duplicated and inconsistent efforts, says Bree Burks, vice president of site strategy for Veeva Systems. Technology like shared drives and DropBox that sites often use to store documents “are simply not built to support the complex workflows, access controls and standardized processes” effective trial operations require, Burks said, yet their familiarity among sites keeps them in use.
Beyond the hefty task of onboarding an eReg platform, sites may be intimidated by the resources needed to adjust to and train on a new system and its processes, and it’s well established that many already feel overloaded by sponsor-pushed technology. Burks believes the biggest things to think about when considering an eReg system are the upfront costs and change management at the site needed to put it in place.
For Emily Knisely, director of compliance and contracting at East Coast Institute for Research (ECIR), the cost of transitioning to an eReg platform was at first unnerving and she assumed her site simply could not afford to make the switch. But after conducting a cost analysis, the site found “we couldn’t afford to not do it,” she said.
Knisely recommends other sites conduct the same evaluation — assess how much staff are paid to handle regulatory tasks outside of their full-time jobs and regular duties and how that salary total matches up to the cost of an eReg system.
ECIR saw drastically reduced return times for startup documents immediately after switching to eReg, going from around one month from receipt to execution to approximately four days. This turnaround time was further enhanced by tweaking site processes once the eReg system was in place, cutting return time down to 2.65 days on average — nearly half the site’s five-day target, she said.
What changed for ECIR? For one, the middleman has been removed from the picture. The site no longer operates by receiving a document in an email, printing it and placing it in a folder to await a signature. It also now has the ability to catch and address errors faster and has seen signature errors, such as incorrect date formats, go away completely. Its investigators can also now sign trial documents on their own time without needing to be anywhere near the site.
When moving to eReg, the choice of provider is essential, and Burks advises sites to choose one that will work with them every step of the way on implementation and recognize their own unique setups.
“Vendor selection is … a critical factor when implementing an eReg solution. The partner should make it as easy and flexible as possible for a site to launch eReg based on its preferences,” she said. “Look for companies that offer end-to-end support, live and on-demand training, and flexible learning opportunities to accommodate each site’s preferred approach and busy schedule.”
Sites should shop around and try out different eReg platforms, says Melissa Bolton, project manager in the University of Utah School of Medicine’s data coordinating center. Ask for demonstrations of specific products and take them for test runs, she advises, and talk to other sites about the product(s) they use and their experiences. The medical school uses a single eReg product within its network for consistency and standardization across sites.
Grace advises sites to carefully consider the functionality of the system with respect to its flexibility. “Many sites report issues with a lack of flexibility, which cause challenges when using eReg systems,” she said. She also recommends a system that enables remote monitoring. “This capability will have significant impact on the sites’ efficiency moving forward,” she said. “Less time needs to be spent with monitors onsite.”
Be crystal clear on why you’re choosing an eReg system as you check out as many vendors as possible to find the best fit, Jimmy Bechtel, vice president of site engagement for the Society for Clinical Research Sites, recommends. In addition, remember to be ready to alter standard operating procedures to account for the new platform.
A strong eReg system can also improve a site’s standing with sponsors, allowing them to track startup metrics and have their first interactions with regulatory personnel. Setting the tone with quick turnaround times and reduced costs for sponsors is a significant benefit that helps sites to stand out, Knisely said.
“That’s going to make your site shine,” she said. “Sometimes it kind of makes me cringe — back when one doctor was on vacation and it took two months to get a financial disclosure form signed … it [looked] like we took two months to do startup.” A sponsor’s not going to want to use a site again if they have to spend tons of time and money to get these documents back to them.