Unify and improve — survey findings reveal streamlining processes key to study improvement

A new life sciences survey has revealed near-universal agreement across the industry that clinical systems and processes must be streamlined to improve study speed and quality. Here, Rik Van Mol, vice president of R&D strategy, Europe, Veeva Systems, outlines key survey findings and what they mean for the life sciences industry.

Many of the challenges companies face today in managing clinical trials stem from disparate processes and systems. Nearly all those surveyed (99%) report the need to unify their clinical applications, including CTMS, EDC and 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 facing them in using clinical applications.

In the case of study start-up, the greater the number of separate applications used, the greater the number of challenges that are reported. 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 study 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 with either 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. Sponsors find that active eTMF applications have significant, positive impacts on inspection-readiness. They also improve activities that are 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. This is a very positive trend, given that a unified clinical environment requires collaborative processes and technology.

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. 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.

Veeva 2017 Unified Clinical Operations Survey

More than 300 clinical operations professionals worldwide were interviewed for the Veeva 2017 Unified Clinical Operations Survey*, which analyses the industry’s progress in improving clinical operations. The results reveal that the journey to unify clinical applications has begun, driven by the need to speed study execution, ease collaboration and achieve greater visibility across an increasingly complex trial landscape.

Key findings:

• Nearly all (99%) of respondents report the need to unify their clinical operations, including CTMS, EDC and eTMF. For more than half, this is driven by the need to speed study execution, improve study quality, ease collaboration, and achieve greater visibility.
• Almost half (49%) of sponsors say the challenge of integrating their eTMF or EDC applications with CTMS limits their organisations’ ability to improve clinical operations.
• Respondents that use two or more applications (76%) more frequently cite issues with site contracting and budgeting (60%), site identification (49%), and study planning during protocol design (40%).
• One in three (31%) sponsors now uses an eTMF application, up from 13% in 2014. Only 16% of sponsors say their clinical operations departments use paper for most or all TMF documents, down from 41% in 2014. Half of document templates are now created electronically (52%), double the number from two years ago (25% in 2015).
• Reporting across multiple applications (60%) is among the biggest challenges organisations face when asked about their clinical solutions. Most sponsors (51%) report the need for better visibility, and one-third say clinical data is tracked outside of their systems.
• Organisations that extensively use data to improve clinical trial processes achieve greater benefits than those that do not leverage 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).

*http://go.veeva.com/eu_unified_clinical_operations_report