Clinical Data Managers Express Concerns Over Future Data Quality Due to Current Inefficiencies
In an enlightening industry study conducted by Veeva Systems, it has been revealed that a staggering two-thirds of clinical data managers and Clinical Research Associates (CRAs) express deep concerns about the future quality of clinical data due to existing inefficiencies. The inefficiencies stem mainly from manual data reconciliation, data cleansing, and validation processes that consume a significant amount of time. According to the findings, every data manager spends over 12 hours per week per study solely managing these manual processes.
The research indicates that the primary contributors to increased time and effort in conducting clinical trials include excessive manual processes or re-entry of data (68%), inefficient workflows (58%), and the use of multiple disconnected systems (59%). These issues not only prolong the clinical trial process but also increase the risk of errors, thus jeopardizing the accuracy of clinical data.
Key insights from the study highlight that automation in data management is a pressing priority for many data managers. When asked how they perceive the role of data managers will evolve in the next two years, 71% of respondents anticipate a significant increase in the automation of data cleansing tasks. This shift toward automated, cross-platform processes could allow data managers to redirect their efforts from repetitive tasks to strategic initiatives, such as risk-based data management.
Furthermore, CRAs have voiced their need for improved documentation and tracking capabilities. Almost 44% of those surveyed indicated that enhancing these areas are critical priorities for them. The fragmentation in clinical systems forces CRAs to validate monitoring visits manually, which can lead to inconsistencies and errors.
However, several challenges stand in the way of enhancing efficiency. Protocol complexity (58%), budget and resource constraints (57%), and resistance to change (48%) emerge as the most significant obstacles faced by clinical teams. This scenario reveals a crucial opportunity for clinical leaders to champion changes that enable data managers and CRAs to operate in more efficient ways.
Interestingly, 81% of respondents believe that integrating clinical systems could streamline the trial processes. In contrast, 75% of data managers reported that their teams are in the process of modernization compared to only 57% of CRAs. Nonetheless, a considerable number believe that Standard Operating Procedures (SOPs) fail to optimize the usage of available tools or do not align with real work practices, indicating a significant gap that hinders progress.
As stated by Manny Vazquez, Senior Director of Veeva Clinical Data Strategy, "The risk of poor data quality extends well beyond a monitoring visit or an approval audit; it can impact the success of submission. The study shows that people conducting trials need change and demand simpler processes and automation for more efficient clinical studies."
This Veeva Clinical Data Industry Research surveyed over 85 data managers and CRAs at sponsors and clinical research organizations (CROs), exploring various technologies and tools employed in conducting clinical studies. The report delves into productivity during Phase III studies, identifies root causes, and offers insights for improvements. For a comprehensive understanding, the full report is available for further reading.
Since its inception, Veeva (NYSE: VEEV) has established itself as a leading provider of cloud solutions for the life sciences sector, offering software, data, and consulting services. Serving over 1,500 customers from major biopharmaceutical firms to emerging biotech companies, Veeva emphasizes innovation, product excellence, and customer success. The organization balances stakeholder interests by aligning with clients, employees, shareholders, and the broader industries in which it operates.
In addition to posing insights on current practices, the study contains forward-looking statements about Veeva’s products and services, expected outcomes, and anticipated benefits from usage, based on current expectations. However, actual outcomes may vary significantly from these estimates due to various risks and uncertainties detailed in the company's SEC filings available for public access. Overall, it has become increasingly clear that to ensure data quality in clinical trials, a shift towards automation and integrated systems is not only necessary but inevitable.
The research indicates that the primary contributors to increased time and effort in conducting clinical trials include excessive manual processes or re-entry of data (68%), inefficient workflows (58%), and the use of multiple disconnected systems (59%). These issues not only prolong the clinical trial process but also increase the risk of errors, thus jeopardizing the accuracy of clinical data.
Key insights from the study highlight that automation in data management is a pressing priority for many data managers. When asked how they perceive the role of data managers will evolve in the next two years, 71% of respondents anticipate a significant increase in the automation of data cleansing tasks. This shift toward automated, cross-platform processes could allow data managers to redirect their efforts from repetitive tasks to strategic initiatives, such as risk-based data management.
Furthermore, CRAs have voiced their need for improved documentation and tracking capabilities. Almost 44% of those surveyed indicated that enhancing these areas are critical priorities for them. The fragmentation in clinical systems forces CRAs to validate monitoring visits manually, which can lead to inconsistencies and errors.
However, several challenges stand in the way of enhancing efficiency. Protocol complexity (58%), budget and resource constraints (57%), and resistance to change (48%) emerge as the most significant obstacles faced by clinical teams. This scenario reveals a crucial opportunity for clinical leaders to champion changes that enable data managers and CRAs to operate in more efficient ways.
Interestingly, 81% of respondents believe that integrating clinical systems could streamline the trial processes. In contrast, 75% of data managers reported that their teams are in the process of modernization compared to only 57% of CRAs. Nonetheless, a considerable number believe that Standard Operating Procedures (SOPs) fail to optimize the usage of available tools or do not align with real work practices, indicating a significant gap that hinders progress.
As stated by Manny Vazquez, Senior Director of Veeva Clinical Data Strategy, "The risk of poor data quality extends well beyond a monitoring visit or an approval audit; it can impact the success of submission. The study shows that people conducting trials need change and demand simpler processes and automation for more efficient clinical studies."
This Veeva Clinical Data Industry Research surveyed over 85 data managers and CRAs at sponsors and clinical research organizations (CROs), exploring various technologies and tools employed in conducting clinical studies. The report delves into productivity during Phase III studies, identifies root causes, and offers insights for improvements. For a comprehensive understanding, the full report is available for further reading.
Since its inception, Veeva (NYSE: VEEV) has established itself as a leading provider of cloud solutions for the life sciences sector, offering software, data, and consulting services. Serving over 1,500 customers from major biopharmaceutical firms to emerging biotech companies, Veeva emphasizes innovation, product excellence, and customer success. The organization balances stakeholder interests by aligning with clients, employees, shareholders, and the broader industries in which it operates.
In addition to posing insights on current practices, the study contains forward-looking statements about Veeva’s products and services, expected outcomes, and anticipated benefits from usage, based on current expectations. However, actual outcomes may vary significantly from these estimates due to various risks and uncertainties detailed in the company's SEC filings available for public access. Overall, it has become increasingly clear that to ensure data quality in clinical trials, a shift towards automation and integrated systems is not only necessary but inevitable.
Topics Health）
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