eClinical Regulatory Trends Impacting Clinical Research

For the past two years, the clinical research industry has seen an acceleration in staff shifting to a remote, work from home model. While this was initially in an effort to keep everyone safer from the COVID-19 pandemic, many organizations are permanently moving toward a remote or hybrid work model for their staff. How has this shaped current regulatory trends, and what is it going to suggest moving forward?

First, we need to understand why many organizations are shifting toward a new work environment. There are a couple of reasons for this move. The first, and perhaps most important, is staff-centricity. The ability to work remotely gives people more flexibility in their days. Whether your staff are parents with kids at home or have appointments to get to, working from home allows them to attend to these needs easier than if they were in an office setting.

From the site perspective, moving towards a remote or hybrid work model can attract talent to your institution as you work to fill the gaps in your staffing. Advertising a flexible work model is good for your organization as you try to recruit new team members. It can also expand the geographic area of potential candidates, as there will be less need to commute to a physical location.

For those working in clinical research operations, technology can provide tools to efficiently and compliantly support any type of model: onsite, hybrid, or remote. Working with eClinical solutions such as eRegulatory (eReg) or eSource eliminates the need for physical binders and centralizes management of regulatory documents and other information, ensuring it’s accessible anywhere.

Easing Staff Burden When Shifting to Remote Work

When moving towards a remote or hybrid work model, make sure you are equipping your staff to do so effectively. For example, a single organization often has staff members dispersed across a city. In the past, keeping your trials moving and being at the right place at the right time required a lot of coordination and making sure everything that was needed was in place. In the past, site staff would sometimes drive across town just to have an investigator sign a document. Switching to an eClinical suite eliminates the need for extensive coordination for all staff, as everything is accessible online, with no physical retrieval needed.

Additionally, an eClinical suite benefits more than just your staff. It also greatly reduces the need for onsite monitoring visits. Currently, many institutions have restrictions in place limiting who is on site. For sites without an eReg management system, this requires more planning and coordination to accommodate to this change. With Advarra eReg, sites are easily able to take their binders, designate which materials are available, set a timeframe, and see what the monitor sees. This enables a swift review for monitors, and less stress for research staff to make sure everything was in place.

Considerations When Adopting an eClinical Suite

One key benefit of going from paper to paperless data collection is eliminating some steps you take on paper that actually don’t provide any value. When moving from paper to digital, taking a step back to assess your current workflows will help you understand which steps need to stay in your digital workflow, and which ones can go. One example of this is evaluating your delegation of authority workflows. Moving from paper to digital is a great time to implement a master delegation of authority process, boosting efficiency within your teams and greatly reducing the “PI signature chasing” that’s prevalent during the delegation process.

However, when making the move from paper to digital, it’s important to understand it will take effort on behalf of your staff to get libraries built up and ready to use. Adopting technology to make your research more efficient for everyone is an investment – if you spend time now on building it up, your staff will continue to reap the benefits over and over. In the long run, your studies will become more scalable and efficient, enabling your staff to do more and serve more participants for each study.

Regulatory Trends to Watch in the Future

As we’ve seen the industry move toward adopting electronic technologies to keep their research moving forward, there are key trends to watch:

Patient Centricity

Utilizing an eClinical software such as eConsent enables research staff to find and enroll more participants in their studies, making it easier for them to actually participate once they are enrolled. The easier it is for someone to participate in a study, the more likely they are to continue on with the study, decreasing the dropout rate. In a time where increased trial complexity is making it more difficult to recruit and enroll participants, doing everything you can do to get participants in your funnel and keep them there is important. For this reason, if you’re looking to adopt technology, you also need to make sure your participants also find it easy to use.

Becoming More Site-friendly

Sponsors are seeing the way sites are becoming overburdened as they use multiple technology platforms to enter in data for studies, which causes significant challenges in staffing levels. As a result, it’s in a sponsor’s best interest to become more site-friendly. Part of doing so is letting sites use their own systems when conducting research, instead of sponsor-initiated technology. While there are a myriad of benefits to this, ultimately letting the sites use their own technology will enhance the overall research environment. This will help staff leave behind the one-off workflows that aren’t cohesive once placed in an electronic format, further streamlining their operational processes and making their research more efficient.

While deciding to convert to electronic processes is a lengthy process with many things to consider, it’s often worth the investment. As the clinical research industry continues to evolve to a hybrid or remote workforce, it’s important to consider the best option not only for your staff, but for any participants who they are working with on a trial.

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