Survey Reveals Concerns Over Clinical Data Quality Due to Inefficiencies

A recent study from Veeva Systems highlights significant concerns within the clinical research sector, particularly regarding the management of data quality. According to the Clinical Data Industry Research, approximately 67% of clinical data managers and Clinical Research Associates (CRAs) believe that current inefficiencies pose a serious risk to the integrity and quality of clinical data moving forward.

Challenges Identified

The study reveals that manual processes involved in data reconciliation, cleaning, and review are notably time-consuming. Most data managers are reportedly spending more than 12 hours a week on these manual tasks alone. This inefficiency stems from a reliance on disconnected systems and a high number of manual entry steps, which not only prolongs workflows but also increases the likelihood of errors in data. Given that 68% of respondents identified excessive manual data handling as a primary factor for inefficiency, it’s clear that the current system is not sustainable.

Furthermore, the reliance on multiple isolated systems exacerbates these problems, with 59% of participants indicating that their workflows are impeded by a lack of integration. This fragmentation complicates the process, leading to increased workloads and heightened risks of poor data quality.

Prioritizing Automation

Among the most pressing findings from the report is the overwhelming consensus—71% of respondents stated that their first priority is to enhance data cleaning through automation over the next couple of years. Automation is seen as a transformative solution that could shift the focus from tedious data management tasks to more strategic initiatives, emphasizing a risk-based approach to data management.

Additionally, CRAs expressed a strong desire for improved documentation and tracking mechanisms. Nearly half of the survey's respondents (44%) pointed to better documentation as a critical priority, particularly due to the manual validation processes necessitated by unconnected systems.

Barriers to Improvement

However, transitioning toward automation and improved systems is not without its challenges. The study highlights three significant barriers: protocol complexity (58%), budgetary and resource constraints (57%), and resistance to change (48%). These barriers highlight the urgent need for clinical leaders to encourage the adoption of more efficient working methods among data managers and CRAs.

The Need for Connected Systems

The survey strongly emphasizes that connected systems are integral to enhancing productivity. A staggering 81% of participants believe that connecting clinical systems is vital in streamlining study execution. Interestingly, while 75% of data managers noted that modernization efforts are underway within their teams, only 57% of CRAs shared this sentiment, indicating a disparity in how advancements are perceived across roles.

Despite the recognition of these needs, many participants believed that standard operating procedures do not sufficiently optimize the tools at their disposal nor align with actual workflows, representing a significant gap that must be addressed.

Final Thoughts

Ultimately, the potential risks associated with poor data quality extend far beyond mere inconveniences such as auditing issues. As highlighted by Manny Vazquez, Sr. Director of Clinical Data Strategy at Veeva, it can significantly affect outcomes during authorization requests. The findings suggest that those involved in clinical trials are calling for simplified processes and increased automation to enhance the efficacy of clinical trials. With tangible steps towards addressing these inefficiencies, the clinical data management landscape could see a much-needed transformation.

For additional insights into improving the state of clinical data management, the Clinical Data Industry Research can provide further strategic recommendations.

About Veeva Systems

Veeva Systems, a leader in cloud-based software for the life sciences industry, is dedicated to innovation and excellence, catering to over 1,500 clients, from large biopharmaceutical companies to emerging biotechnology firms. Their commitment to serving all stakeholders emphasizes a balance of interests within the industry.

For more information, visit veeva.com/eu.