Veeva Systems has officially published the results from its Veeva Clinical Data Industry Research, which saw nearly two-thirds of data managers and clinical research associates (CRAs) reporting that inefficiencies in manual data reconciliation, cleaning, and review can put clinical data quality at future risk.
Going by the available details, this particular research claims that main instigators responsible for adding time and effort in executing clinical trials are actually too many manual steps or data re-entry (68%), inefficient workflows (58%), and using multiple disconnected systems (59%) More on the same would reveal how each round of manual data review, cleaning, and reconciliation was found to take a data manager more than 12 hours per week, per study to complete.
This conclusion was reached upon after nearly all respondents (97%) said they perform reconciliation outside of clinical systems or use a mix of systems to complete the process. Such a disconnected approach, like you can guess, significantly increases the burden on clinical teams and the risk of poor data quality.
Talk about the relevant research on a slightly deeper level, we begin from automation emerging as the number one priority for data managers. You see, when asked how the data manager role will evolve over the next two years, 71% of respondents revealed an intention to use more of automation for data cleaning.
Next up, the study found a majority of CRAs demanding better documentation and tracking. The sheer lack of connectivity across clinical systems basically requires CRAs to conduct manual validation of monitoring visits. As a result, nearly half (44%) said improving documentation and tracking is their top priority.
Another detail worth a mention is rooted in the fact that complexity, resources, and resistance to change established themselves as among the biggest barriers. From a practical standpoint, main challenges surrounding efficiency spanned protocol complexity (58%), budget and resource constraints (57%), and resistance to change (48%).
Beyond that, the research in question also went on to prop up connected systems as central to driving productivity. Most respondents (81%) would go on to claim that connecting clinical systems would streamline study execution. Furthermore, 75% of data managers said their teams are in the process of modernizing, as compared to 57% of CRAs.
Having said so, many continue to feel SOPs do not optimize use of available tools or align with real-world workflows, highlighting a gap that can prevent progress.
Among other things, it ought to be acknowledged that Veeva Clinical Data Industry Research surveyed more than 85 data managers and CRAs across sponsors and clinical research organizations (CROs) who use various technologies and tools to execute clinical trials. As far as the focal point is concerned, it examined productivity in Phase III trials, focused on identifying root causes, and offered actionable insights for advancement.
Founded in 2007, Veeva Systems’ rise up the ranks stems from bringing forth industry cloud for life sciences with software, data, and business consulting. The company’s excellence in what it does can also be understood once you consider it is currently trusted by more than 1,500 customers, ranging from the world’s largest biopharmaceutical companies to emerging biotechs.
“The risk of poor data quality spans far beyond a monitoring visit or listing review, potentially impacting regulatory submission success. The research shows that the people executing studies need change and are asking for simpler processes and automation for more efficient clinical trials,” said Manny Vazquez, senior director, Veeva Clinical Data strategy.
