Over the last 20 years, the industry has focused on developing solutions to help streamline and accelerate the clinical trial process for two of the three main clinical trial stakeholders: sponsors/CROs and patients/volunteers.
But little effort has been spent on technology to help the third major stakeholder—the sites—to be more productive. If we can provide solutions to help sites improve productivity by moving from a mostly paper to a paperless environment, we will have solved the last missing piece to the trial acceleration puzzle.
Recently, I visited with a site in Raleigh, N.C. Raleigh Neurology Associates is not just a typical site, it is one of the largest private neurology practices in the U.S., and clinical trials are an important aspect of its operations. In fact, this site currently has 40 providers working on over 50 active clinical trials.
Taking a tour of the facility, I was struck by the efficiency with which work was managed. The space was organized, the staff courteous and the facilities extremely well maintained. I was surprised to learn the site is leveraging eClinical portal technology to aid in management of clinical trial activities. This wasn’t always the case—the site was quick to point out this is new technology it has been beta testing for nine months.
eClinical portals have been used by the industry to help with site feasibility, activation, training and site management activities, and they help streamline the many tasks necessary to effectively manage clinical trials. They have been highly effective for the sponsors and CROs that have used them for the last five to 10 years. And although these solutions were not made available to sites until very recently, the sites that do use these eClinical portals already are seeing significant improvements in both productivity and performance.
Let’s look at document management as one example. Imagine manually keeping up with the latest versions of source documents for multiple studies. Treatment plans change, protocols may go through several amendments and version control issues easily can become in disarray if handled manually, causing unwelcomed protocol deviations. By using a cloud-based eClinical portal to manage and version these documents, we reduce the time it takes to find the most recent version of a document while reducing the risk of using an old version. It may be hard to imagine, but many sites must search email or shared drives to find the latest versions of key study documents. Other tools available on these portals include quick links and SSO with some of the leading EDC and IVRS vendors, password managers, IRB submission/tracking tools, training/SOP certificate tracking, key document expiring alerts and other site-friendly solutions to manage tasks and activities.
Sites are comprised of real people who physically and emotionally touch the lives of the patients with whom they interact. Is it plausible to assume if a study coordinator spends less time bogged down by manual processes and paperwork and more time with patients, he or she could recruit and enroll more patients? The sites say it has a significant impact. Raleigh Neurology Associates’ director of clinical research, Sean Walsh, MBA, ACHE, for example, said, “We have seen a 30% increase in productivity and a 25% increase in patient recruitment and retention on the studies that use the SitePortal v. our traditional process. This reflects the time our coordinators saved by no longer having to track down documents in multiple locations.” In addition to the measurable improvements in productivity, the site is in a better position to conduct more research studies—more efficiently and with better compliance than with traditional paper processes.
As these portals are deployed into full production, sites will be able to transition from a primarily paper to a paperless environment in the cloud. This opens the door for a wide range of benefits and opportunities, including faster study start-up, higher enrolling sites with fewer errors, fewer redundant tasks for sites, fewer user credentials and remote monitoring.
Ashley Tointon directs patient engagement programs at ePharmaSolutions, combining traditional methods with innovative, data-driven techniques to provide sponsors high-impact, cost-effective recruitment and retention programs. She has more than 18 years of patient recruitment and project management experience supporting clinical trials and the pharmaceutical industry.
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