Clinical research sites are under more pressure than ever to move faster and be more efficient. Without the right digital tools, it is challenging to keep pace while maintaining quality. Labor-intensive processes, large volumes of paper documents, and ever-increasing operational costs can create a cumbersome approach to clinical research management.
Despite these operational inefficiencies, Bree Burks, RN, MSN, vice president of site strategy for Veeva Systems, says many sites are reluctant to explore new technologies since their biggest challenge is having too many systems with different processes and logins. Sites use a mix of their own technology and sponsor applications, so staff often have to duplicate work or maintain complex integrations across two environments, she notes.
However, “a digital clinical trial brings together study stakeholders, linking sponsors, sites, and patients for seamless information exchange,” says Burks, who will present on this topic at the ACRP 2022 conference in Orlando in April. Previewing the concepts she will bring to the conference, as well as a column she has written for the June issue of ACRP’s Clinical Researcher journal, she adds that to advance toward this reality, site-centric technology is unified with sponsor systems for clinical operations and data management, and patient-facing applications.
Burks offers the following examples (to be described more fully in Clinical Researcher) of ways this can streamline processes to boost efficiencies for sites:
Improve the site and sponsor relationship—The transactional nature of clinical trials is slowing down processes. A digital clinical trial that brings together site- and sponsor-owned systems can significantly reduce e-mail traffic since most requests can be digitally executed or automated. This improves communication across stakeholders and reduces frustrations with duplicate information requests or last-minute scrambles to search e-mails and find documents.
Optimize site operations—Digital clinical trials can simplify information sharing to improve site operations, free valuable time for site staff, and speed study start-up. For example, when a site receives a start-up package, documents are accepted and auto-filed within its eRegulatory system. Study teams can then route documents for training, collect signatures, and share completed documents with the sponsor seamlessly.
Standardize the way sites work with sponsors—Sites need ways to reduce multiple technology trainings, logins, and passwords to streamline processes during trials. A site-centric system that connects to sponsors centralizes information for standardization across studies. Using a standard eRegulatory system to complete tasks and share documents reduces training and administrative burden.
Provide a better patient experience—While COVID-19 accelerated the move to decentralized trials, it also underscored the importance of the holistic patient experience. Digital clinical trials can significantly enhance the patient experience by improving the consent process and delivering greater convenience.
“A digital and connected study advances the industry, shifting from paper-based and manual to digital and automated,” Burks says. “As research sites capitalize on the efficiencies of unified systems, they play a critical role in accelerating clinical development for patients in need.”
Edited by Gary Cramer