Using Clinical Trial Data to Improve Processes
Few organizations use the data they have gathered from clinical trials to improve processes. While process improvement projects are initiated with great energy, they often lose momentum and get set aside for more pressing priorities.
Companies Miss Process-improvement Opportunities
It is well known that trial data helps identify trends to drive process improvements throughout studies or a portfolio of studies, yet many organizations performing clinical trials are less than eager to dive in due to the sheer amount of time data analysis takes.
One in four companies (23 percent) do not use or rarely use data to improve study processes. And only roughly half (43 percent) use data for process improvement in select cases.
With eTMFs on the rise, there has been a significant change as the industry shifts from passive to active TMF management—and this change has significantly enabled easier access to analyze clinical trial data.
Active TMF management allows for systems and processes to work in tandem to reach the end state. Organizations that use eTMF data to drive efficiencies are coming out ahead with streamlined processes, increased transparency, simplified tracking and enhanced security. With eTMF integration, organizations can manage documents and processes in real time.
Benefits of Data-inspired Process Improvement
Using data to improve study processes significantly affects the bottom line. According to a 2016 Veeva study regarding major changes underway in clinical operations, organizations that use clinical-trial data see the following benefits:
- Improved audit and inspection readiness at 67 percent, compared to 29 percent.
- Overall improved visibility at 53 percent, compared to 14 percent, into performance metrics detrimental to their processes.
- Overall cost savings reporting at 47 percent, compared to 10 percent.
In addition, a 2017 Veeva study measured improvement to each step of the clinical trial process, finding that improvements enabled through data analysis reduced patient recruitment cycle time by 48 percent and rework was reduced by 32 percent. Overall, the clinical research cycle time improved by 41 percent.
Assistance in Data-driven Process Improvement for Clinical Trials
The move to eTMF has made it easier than ever for trained, experienced, clinicians that understand clinical trials, processes, and data analysis to access and address clinical trial data.
The new challenge? Accessing these hard-to-find trained, experienced, clinicians who can work in teams to process large volumes of information efficiently and accurately.
Fortunately, Shearwater Health can help. We have the human resources you need and they can deliver results that can transform your organization’s efficiency. Contact Shearwater Health today: firstname.lastname@example.org or 615-921-9510.
You’ll be impressed by how we can help you.