Life sciences moves to unify clinical operations to improve study quality

Veeva’s Rik Van Mol explains how streamlining the clinical process will not only improve the speed but also the quality of the data…

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It’s no longer a question of if, but when. The life sciences industry is moving toward a unified clinical model by streamlining clinical systems and processes.  

The need for a unified clinical environment is quantified by more than 300 clinical operations professionals worldwide who were interviewed for the Veeva 2017 Unified Clinical Operations Survey. The findings show that there is now near-universal agreement that clinical systems and processes must be streamlined to improve study speed and quality.

Here, I outline key findings from the survey and what they mean for the life sciences industry.

Unifying clinical systems and processes 

Many of the challenges companies face today in managing clinical trials stem from disparate processes and systems. Nearly all of those surveyed (99%) report the need to unify their clinical applications, including clinical trial management system (CTMS), electronic data capture (EDC), and electronic trial master file (eTMF). Respondents cite faster study execution (65%), improved study quality (63%), and cost savings (59%) as the top three most important drivers.

The average number of applications used to manage clinical studies is four, with more than one-third of respondents (38%) saying they use at least five applications. Not surprisingly, EDC, introduced nearly 20 years ago, is still the most commonly used application (81%), followed by CTMS (59%) and eTMF (57%).

The negative impact from silos is obvious. Respondents cite integrating multiple applications (69%) and reporting across applications (61%) as the two biggest issues with their clinical applications.

Additionally, the greater the number of separate applications used, the greater the number of challenges reported in study start-up. Respondents using two or more applications (76%) more often cite issues with site contracting and budgeting (60%), site identification (49%), and study planning during protocol design (40%).

While the number of applications is an issue, the survey also reveals that CTMS applications are not keeping up with the demands of today’s clinical trials. Nearly all sponsors (98%) report challenges with their current CTMS applications, while the most frequently cited shortcomings are tracking and reporting (38%) and integrating either with an eTMF application (37%) or an EDC application (37%). Sponsors also report significant deficiencies with CTMS applications, including inability to support key functions such as resource management (77%), study and site feasibility (76%), financial management (75%), and issue/task management (73%). Monitoring is the only process that a majority of sponsors (54%) say their CTMS applications fully support.

Yet, adoption of modern, active eTMF applications is on the rise. More specifically, however, the research shows that there is a major move away from “passive” systems to “active” eTMF solutions. One in three sponsors (31%) now uses a purpose-built eTMF application – more than double the number reported in 2014 (13%). Sponsors find that active eTMF applications have significant, positive impact on inspection-readiness and improve activities key to unifying clinical operations, including automated tracking and reporting of documents (68%), central and remote auditing (62%), and visibility into key study performance metrics (50%).

Streamlining collaboration

In an effort to streamline collaboration and implement end-to-end processes, sponsors are moving away from manual systems. Previous surveys have shown that sponsors are decreasing their use of paper, and that trend continues in this year’s survey. Across almost all functional areas measured, the number of TMF documents managed on paper is down by at least half among sponsor companies since 2014.

Clinical operations departments lead the way, with just 16% of sponsors now reporting that most to all TMF documents managed are on paper, a 25 percentage-point drop since 2014. Given that more than half of the documents in a trial master file are managed by clinical operations, the potential impact of this reduction is significant.

However, there is still room for improvement in the areas of collaboration with external partners. More than two-thirds of sponsors (68%) use email to exchange TMF documents with CROs. In contrast, only 19% use their eTMF applications to exchange TMF documents with external partners. The problem, of course, is that emailing documents puts information outside of the controlled processes, making it harder to track and collaborate efficiently.

Using data to improve the study process

Metrics can help to identify trends to drive process improvements across an individual study or portfolio of studies. Yet, almost one in four (23%) is not using or rarely uses data to improve study processes, while roughly half (46%) only use it in some cases.

However, the amount of data collected, and the extent to which it is leveraged, has a direct impact on improvements to clinical operations efficiency. Organisations that extensively use data to improve clinical trial processes see more benefits than those not leveraging data, including easier collaboration (50% to 25%, respectively), central and remote auditing (50% to 31%, respectively), and automated tracking and reporting of documents (54% to 38%, respectively).

The drive for a unified clinical model

There is industry-wide recognition that a move to a unified clinical model is necessary to address the growing need to improve the quality and speed of study execution. Clinical leaders are looking to achieve higher levels of performance across their study portfolios by implementing end-to-end processes and systems, streamlining collaboration, and leveraging insight from across the trial lifecycle.

The majority of challenges sponsors face today in managing clinical trials stem from the siloed nature of their processes and applications. Some of the most prevalent applications in use today, such as EDC and CTMS, are based on first-generation technology. They lack the core functionality, modern architectures, and usability required to enable true end-to-end processes and visibility.

Organisations that adopt modern, purpose-built applications, such as “active” eTMFs, report fewer challenges and see greater benefits to their studies. And when unified, these applications enable life sciences organisations to establish repeatable, collaborative processes and increase oversight and accuracy by consistently leveraging insight across their clinical portfolios.

About the author

Rik Van Mol is vice president of R&D strategy, responsible for the Veeva Vault R&D suite of applications in Europe. He has nearly 20 years of experience in business/IT consulting and regulated content management in the life sciences sector. Rik’s experience has been built on assisting clients through complex transformational programs across the life sciences value chain, including clinical, regulatory, and manufacturing/supply chain areas for some of the world’s largest companies.

Veeva Systems Inc is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 525 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia, and Latin America. For more information, visit