COVID-19 has given the clinical trials industry the push it needed to go paperless, with 84 percent of sites, CROs and sponsors already doing so or poised to make the switch to electronic data management (EDM) systems. 

The industry is approaching the apex of what Nathan Levens, director of virtual solutions and technology for RealTime, calls the bell curve of e-source adoption, with about 50 percent of the industry already using e-source and another 34 percent of organizations preparing to transition, Levens told the Society for Clinical Research Sites (SCRS) annual conference last week. But about 16 percent of trial organizations will be “laggards,” he predicted.

Late adopters are usually those who waited for the product to be perfect, Levens said, while early adopters are those who “see the vision and want to ride the wave of that new technology.”

He encouraged hesitant sites to think about what they need now. “If you can find a system that solves at least 90 percent of your pain points,” he said, “it’s worth it to pull the trigger.”

One site that proves Levens’ point is Pinnacle Clinical Research in Texas, which has been able to weather the pandemic with the help of e-source, according to CEO Gail Hinkson. At the start of 2020, Pinnacle was conducting 40 trials and enrolling up to 20 new subjects per month, which meant it was hosting about 50 on-site monitoring visits per month, Hinkson said. 

With the onset of the pandemic, Pinnacle’s trial activity didn’t slow but sponsor on-site monitoring came to a halt, creating a data backlog for both sites and sponsors. And because sponsor payments for trial activities are triggered by submission of data from site to sponsor, Pinnacle’s revenue began to slow as well.

But because 80 percent of the site’s data was housed in electronic systems, Hinkson said, and Pinnacle immediately moved to transfer their paper records as well, sponsors were able to begin remote monitoring, cut down the backlog and restart cash flow.

“It wasn’t until we were able to have CROs and sponsors … perform remote data monitoring that we really started to see a reduction to the data backlogs and their related downstream effects,” she said.

Pinnacle’s experience was so positive that its parent network, Summit Clinical Research, is now considering transitioning all its sites to e-source, said Hinkson, who also serves as vice president of Summit.

There is a cost to making such a transition, acknowledged RealTime CEO Rick Greenfield at the SCRS conference, but it’s “extremely minimal” when you consider the benefits and paying for the transition to electronic systems will save them money in the long run.

If a sponsor can save the cost of at least one or two monitoring trips by adopting systems that allow for remote oversight, Levens pointed out, “that probably pays for the system.” 

Raymond Nomizu, cofounder and CEO of electronic solutions company CRIO, offered an example of potential savings. Assuming a sponsor with 10 sites conducts four on-site monitoring visits to each site and travel expenses average $1,600 per visit, the sponsor saves $64,000 by eliminating monitoring visits. And eliminating the cost of archiving paper records can save an additional $1,000 per site. Taken individually, the savings are small, but they can add up to hundreds of thousands of dollars for a multisite trial.

But beyond costs and savings, there are challenges to electronic system adoption, all three experts agreed. One question sponsors must consider, Nomizu said, is whether the CRA should become a data manager or if the two roles should be separate and the CRA be allowed to focus on protocol compliance, good clinical practice and training. And sponsors moving to 100 percent remote monitoring should establish criteria for when risk factors trigger the need for an on-site visit.

“You also need to think about when you want to escalate to on-site monitoring,” Nomizu said. There are times when in-person meetings are necessary to address operational challenges, such as the re-education of site staff and investigating further any issues that might have been flagged by the remote monitoring process.

Workflows will be different, too. Sites need to understand that new systems mean new start-up processes, Levens said. “Not more difficult, just different.” And switching to electronic from paper doesn’t necessarily mean monitoring visits will be faster.

“The big one here is enforcing site training and adoption,” Nomizu said. He encourages sponsors to scrutinize heavily the vendors’ track records in training sites and getting them to use the electronic system effectively. 

Greenfield and Levens encouraged sites to be ready for change. “It’s difficult to get buy-in sometimes,” Greenfield said, “and this is something that we really have to champion with our sites that are moving into these systems.”

Sites and sponsors should designate a leader or a team of leaders for the transition, Levens recommended. “Your staff will run into challenges and obstacles and you need your people, those champions, that can navigate through those obstacles.”

Now that a lot of sites are adopting electronic source systems, sponsors have the opportunity to “work with the site technologies in a way that provides benefit for both” the sponsor and the site, Nomizu said. Data access will be easier and immediate for both sides and remote monitoring will be more seamless, a benefit that will last far beyond the pandemic.

Nomizu discussed three levels of site involvement a sponsor can undertake. At the lowest level, the sponsor merely encourages sites to implement electronic systems and offers to reimburse them for the expense of the technology they choose. “By taking cost off the table, you’ll encourage sites to adopt the technology,” he said. The drawback at this level is that different sites will be at different stages of adoption and some traditional monitoring may still be necessary.

At the second level, a sponsor could provide its own technology, along with standard templates and processes. “This can be done upfront as part of the contract process where, as a condition of participation, the sites agreed to use the source technology,” Nomizu said. The challenge here is that some sites will be unfamiliar with the technology and will need additional training. Also, this approach puts the burden of validating the technology solely on the sponsor, he said.

Sponsors that want to go all in can integrate their entire electronic system with sites’ systems – such as eCRF, electronic data capture (EDC) and clinical trial management systems – for seamless transfer of data between sites and sponsors. With this approach, there is no data lag, eCRF files are automatically kept up to date and source data verification is not necessary. It can be difficult to map sites’ EDC fields to the sponsor’s system, and validation would be needed, Nomizu said.