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CROs lead industry-wide shift to modernize trial processes
PLEASANTON, Calif.—Contract research organizations (CROs) continue to lead the adoption of modern clinical applications to increase operational efficiency, simplify trial collaboration and improve study quality, according to a new global industry survey from Veeva Systems. The “Veeva 2018 Unified Clinical Operations Survey: Annual CRO Report” examines CROs’ progress in unifying clinical operations by gathering the experiences and opinions of global CRO respondents, and it examines the drivers, barriers and benefits of a unified clinical operating model.
The report reveals that CROs lead sponsors in adopting purpose-built clinical applications, particularly in study start-up (33 percent of CROs vs. 17 percent of sponsors) and clinical trial management systems (CTMS) (66 percent vs. 54 percent). This momentum is consistent with organizations’ focus on improving study visibility and execution, the two top drivers among CROs for unifying clinical applications.
“There are two factors that drive CROs to adopt purpose-built clinical applications. First, the CRO business is incredibly competitive. CROs look for every advantage they can gain over one another ... In a world where many services can be viewed as commodities, technology offers compelling differentiation,” says Jim Reilly, vice president of Vault Clinical at Veeva Systems. “The second factor is operational efficiency. Purpose-built, modern platforms allow CROs to drive a higher degree of operational efficiency, while also supporting the scale of their data and process needs.”
“At Atlantic Research Group (ARG), we rarely contract with smaller biotechs that have their own systems or applications in place. For them, an investment in a CTMS would be a significant undertaking. On the other hand, larger companies running many trials likely benefit from implementing these clinical management systems themselves, knowing that they will need them for years to come. Sometimes they even ask us to use their system instead of our own,” adds Hunter Walker, chief technology officer at ARG.
A third (33 percent) of CROs cite collaboration as a challenge. Unified systems and processes make it easier for CROs, sponsors and sites to share information throughout the course of a trial. This contributes to CROs’ move toward advanced clinical applications; most (91 percent) have initiatives planned or underway to unify their clinical applications for improved trial performance, and continue to shift away from manual processes and legacy systems in favor of purpose-built clinical applications.
Speeding study execution has become a top priority for CROs, as sponsors continue to outsource study start-up processes. Findings show that nearly 80 percent of CROs are taking steps to improve study start-up. This supports the fact that an increasing number of CROs are investing in technology to improve trial efficiency.
“Many CROs are aiming to become more sophisticated in how they plan and manage activities along the critical path to activation in order to navigate the growing complexity of trials and the competitiveness of the CRO landscape. To do so, they are looking for study startup technologies that are predictive and proactively highlight risks across multiple trials, potentially even suggesting alternate execution plans in order to finish startup activities ahead of or on time,” notes Reilly.
Easier collaboration among trial partners is one of the top three most important drivers for enhancing study start-up processes. Almost half of CROs (45 percent) say collaboration during study start-up continues to be an area of improvement.
“Sponsors and CROs both want data updated in near real-time. If data entry lags, it will take longer to make informed decisions or troubleshoot issues that will inevitably arise,” mentions Walker. “That’s why we do not want to execute more data entry than is necessary, which requires a single-source-of-truth, so that data is either entered by personnel once—or, better yet—is easily shared or transported from another system and all in near real-time.”
CROs report the need to improve their use of CTMS in trial operations, with 81 percent citing CTMS system issues as a limiting factor. Most CROs have CTMS applications which can’t fully support a range of key functions, including investigator relationship management (93 percent), governance and oversight (89 percent), and study metrics and reporting (85 percent). The majority of CROs see improving CTMS systems and processes as a way to enable proactive risk identification (74 percent), improve study analytics and reporting (60 percent), and enhance visibility to effectively manage and optimize trials (59 percent).
“Traditionally, CROs have been reluctant to provide direct access to their CTMS applications as a way to share trial status because it’s either been technically difficult or because security in legacy systems has not allowed for the level of control that CROs desire when sharing operational data,” Reilly says. “Modern CTMS applications in the cloud remove the technical and information control issues of the past, allowing for direct sponsor views or for the automated flow to a sponsor’s own CTMS.”
The number of CROs using an electronic trial master file (eTMF) application has more than doubled since 2014, from 21 percent to 54 percent. This increase has been matched by a decline in general purpose content management systems and file shares, signaling a shift from passive TMF management toward an active TMF operating model where TMF processes and information are managed in real-time.
“As opposed to passive TMFs of the past, where generic document management systems were used as a repository to collect completed content at study close, an active TMF tells the story of the trial as it unfolds. CROs with an active TMF develop and collect content in support of trial activity in process and in real time, such as when a new investigator comes onboard, or a protocol is amended,” Reilly mentions.
CROs have made significant progress in modernizing trial processes with purpose-built eTMF applications. Organizations using advanced eTMF applications report greater visibility into TMF status and fewer challenges, including with study partner collaboration.
“With a high-performance, active eTMF application, no one on the team should ever wonder about the completeness of the TMF. In addition to features like ‘Expected Documents Lists,’ an eTMF linked to a CTMS and EDC can save team members the trouble of manually filing monitoring reports and casebooks into their respective folders,” Walker concludes. “Confident that the documents will be there, CROs and auditors can shift their focus on more significant tasks that speed trials.”