Electronic Source (eSource) presents a compelling case for reducing monitoring costs in clinical trials. By streamlining data collection, improving accuracy, enabling remote monitoring, strengthening compliance, and altogether reducing administrative burdens, eSource solutions provide a powerful tool for clinical research sites, sponsors, and CROs looking to achieve better outcomes. There’s a reason why thousands of sites worldwide have already made the transition to eSource. For those considering the switch from traditional paper-based methods to eSource, the potential for cost savings and increased efficiency makes this a strategic decision that can lead to greater across your clinical trials. In this post, we’ll explain five ways eSource reduces monitoring costs in clinical trials.
1. Streamlined Data Collection
One of the primary benefits of eSource is the ability to streamline data collection processes. Traditional methods often require staff to manually enter data from paper forms into electronic systems. This process consumes valuable time and increases the risk of human error as well as data discrepancies. Each time data are transferred manually, there is potential for transcription mistakes, misplaced information, or incomplete entries. These issues can delay trials and require additional resources to correct.
With eSource, data is entered directly into a secure, electronic platform, allowing for immediate validation and review. This digital workflow reduces transcription errors and supports real-time data accuracy. Furthermore, eSource minimizes redundancies, making it easier for monitors, data managers, and clinical staff to access, analyze, and act on up-to-date information. All without repeated cross-referencing or manual input.
Cost Implications: The reduction in manual and duplicate data entry alongside the associated decrease in error correction requirements directly lowers monitoring costs. Since eSource captures data accurately and contemporaneously from the start, less time and labor are needed for data reconciliation. In turn, this reduces the need for on-site monitoring visits and minimizes the resources allocated to correcting errors. By cutting down on both time and workforce demands, eSource allows clinical research sites to operate more efficiently, translating to cost savings throughout the study lifecycle.
2. Better Data Integrity
Accurate, reliable data ensures that study findings are valid, supporting regulatory approval processes and preserving the integrity of trial outcomes. Inaccuracies in data can lead to delays, regulatory issues, and even compromise the scientific validity of the study, potentially resulting in adverse patient outcomes or rejection by regulatory bodies.
eSource is designed with built-in validation checks that verify data at the point of entry, alerting users to inconsistencies or incomplete entries immediately. This functionality allows for real-time data quality assurance, reducing the likelihood of errors being propagated through the data analysis process. For instance, eSource can flag unusual data entries, prompt users for additional verification, or ensure procedures follow the correct order. By catching discrepancies at the moment of entry, eSource minimizes the need for data clean-up and verification later in the trial. This enables higher-quality data collection from the outset.
Cost Implications: Improved data integrity through eSource reduces the need for costly rework, which often involves significant time and labor to correct errors after data collection. These corrections can be resource-intensive, requiring additional monitoring visits, data management oversight, and potentially more frequent data reviews. By minimizing data inconsistencies early on, eSource lowers the risk of regulatory issues that can incur fines, compliance penalties, or even halted studies. This proactive approach to data accuracy safeguards trial outcomes and results in substantial long-term cost savings by mitigating the financial risks associated with data-related compliance issues.
3. Remote Monitoring Capabilities
Restrictions on travel and physical access to sites presented major challenges during the pandemic, highlighting the importance of remote monitoring in clinical trials. With eSource, monitors and study teams gain the flexibility to access real-time data from any location. This allows oversight of trial progress without the need for frequent in-person visits. Remote monitoring enables teams to conduct regular data reviews, identify trends, and address potential issues promptly without the logistical and financial burden of traveling to the site.
Moreover, this capability optimizes resource allocation by allowing monitors to direct their focus toward sites or data points that truly need attention, versus spending time on routine site visits. It also improves data accuracy and timeliness, as real-time access to data ensures that issues can be detected and resolved earlier in the process. This reduces the likelihood of costly downstream corrections.
Cost Implications: By reducing the necessity for on-site visits, eSource can significantly lower monitoring costs, particularly those associated with travel, accommodation, and the time required for in-person monitoring sessions. This reduction in travel-related expenses alone leads to considerable savings, especially for trials spanning multiple sites or regions.
4. Compliance and Audit Trails
Regulatory compliance ensures patient safety, data integrity, and adherence to ethical and legal standards. Non-compliance can lead to costly delays, penalties, or even trial termination. eSource in clinical trials is purpose-built to meet these requirements, featuring comprehensive capabilities that make the process manageable and transparent.
A key component of eSource is the automated audit trail feature. Adult trails meticulously record all data changes, including who made the changes, when they occurred, and the specifics of each modification. These audit trails provide a complete, timestamped record of every action, creating a transparent log that’s easy to track. This automated documentation is invaluable during internal reviews, allowing teams to quickly verify data integrity and protocol adherence.
For external audits, this built-in transparency simplifies the process for regulatory authorities. With clear audit trails, eSource helps to minimize discrepancies and demonstrate to auditors that the trial is conducted according to Good Clinical Practice (GCP) and regulatory guidelines like FDA’s 21 CFR Part 11. This structured, proactive approach to compliance ensures that documentation is always audit-ready, reducing the stress and resource strain often associated with audit preparations.
Cost Implications: Streamlined compliance processes significantly reduce the administrative burden on clinical staff, as the need for manual documentation and record-keeping is minimized. Automated audit trails eliminate time-consuming paperwork. This allows staff to focus on more strategic tasks, which can improve trial productivity. Additionally, the ability to demonstrate full compliance during audits reduces the likelihood of penalties or trial disruptions, saving organizations from costly compliance-related expenses. This proactive framework also cuts down on resources spent preparing for and responding to audits. The result is substantial savings throughout the trial lifecycle.
5. Reducing Administrative Burden
Traditional data collection methods are typically paper-based, which can create a substantial administrative workload for clinical trial teams. Managing paper documents requires extensive storage, meticulous organization, and regular updates, making it labor-intensive to maintain accuracy and security. This method often involves coordinating data entry and verification across multiple stakeholders. It requires back-and-forth communication, manual updates, and frequent error checks. These processes consume significant time and effort. As a result, staff are pulled away from core activities like patient care, protocol management, and site coordination
eSource addresses these challenges by automating and streamlining routine tasks, from data collection to real-time validation checks. This automation minimizes the need for manual data entry, because information can be captured directly at the point of care and synchronized across systems. By automating these processes, eSource frees clinical trial teams to focus on higher-value activities. The reduction in time spent on data collection and error reconciliation translates to a smoother, faster trial process.
Cost Implications: Reducing administrative work with eSource directly translates to lower operational costs. By automating routine tasks, eSource reduces the need for additional staff hours devoted to data management and minimizes the costs associated with paper storage, printing, and handling. This modern process allows trial teams to achieve more with their existing resources, improving productivity and efficiency. With fewer hours required for data handling, error correction, and document retrieval, clinical research sites can allocate their resources more effectively. Altogether, this leads to better trial performance and greater financial sustainability over time.
A Real-World Case Study: Lessons Learned from the University of the Sunshine Coast’s eSource Transformation
The University of the Sunshine Coast (UniSC) serves as a powerful example of how adopting eSource can deliver significant cost savings and operational efficiency. Prior to transitioning to RealTime-eSource, UniSC relied on traditional paper-based methods, which were both resource-intensive and limiting. Coordinators could only manage three studies at a time, resulting in just 266 patient visits in 2018. This inefficiency constrained the site’s capacity to scale and maximize its trial operations.
With the adoption of eSource, UniSC eliminated the burdens of paper workflows by centralizing source documentation and reducing administrative tasks. These advancements allowed coordinators to manage five to seven studies simultaneously, more than doubling their capacity. Patient visits surged to an impressive 2,617 by 2023—a tenfold increase. This operational efficiency translated directly into cost savings. Leveraging eSource, UniSC scaled its trial operations without a proportional increase in staffing costs. Furthermore, the time saved on manual tasks was reinvested into higher-value activities, that improved trial quality and timelines. These efficiencies led to a remarkable 28-fold revenue growth, showcasing the financial impact of eSource. Through centralized and standardized workflows, UniSC achieved substantial cost savings, significantly expanding its ability to conduct trials and serve more participants.
Wrap Up
In summary, technology trends in clinical trials suggest that eSource adoption will continue to accelerate in the coming years. And for good reason. eSource delivers substantial cost-saving benefits across multiple aspects of trial operations. One of its most transformative advantages is enabling remote monitoring, which has become essential in today’s decentralized and hybrid trial environments. By reducing the need for frequent on-site visits, sponsors and CROs can cut travel-related expenses significantly and reallocate those resources to other high-value areas. This shift saves money and allows monitors to focus on critical tasks, resolving potential issues faster with real-time data access.
Beyond cost savings, eSource offers additional benefits that make it indispensable for modern clinical trials. Its powerful features, including audit trails and real-time data validation, mitigate the risk of costly compliance penalties and simplify the auditing process for both internal and external stakeholders. Moreover, eSource improves data accuracy, fosters better collaboration, and accelerates decision-making with centralized, real-time access to essential trial data. Ultimately, these combined advantages make eSource an investment that drives financial savings and supports better trial outcomes.
