BEFORE
The University of the Sunshine Coast Before RealTime
- Difficult to manage paper source documents
- 3 studies per coordinator
- 266 visits in 2018
AFTER
The University of the Sunshine Coast After RealTime
- Centralized eSource documents
- 5 - 7 studies per coordinator
- 2,617 visits in 2023
Overview
The University of the Sunshine Coast (UniSC) in Queensland, Australia established its clinical trial practice in 2016. Since then, it has evolved from an enterprise initiative into a community-based clinical trial operation working closely alongside community doctors, specialists, hospitals and different health environments to expand patient access to clinical trials.
After launching with a single site, they moved to a multi-site model and currently have five sites covering a broad scope of therapeutic areas. Today, the team has expanded to include around 70 site personnel and 14 investigators across its various locations.
UniSC was grappling with huge piles of paper and operational inefficiencies that made it difficult to smoothly conduct multi-site decentralized trials for the rapidly expanding network. Using RealTime-eSource, they were able to enforce protocol compliance, centralize source documents, eliminate paper workflows and reduce time on administrative tasks with streamlined workflows.
The Challenge
As an organization renowned for its commitment to innovation, UniSC held a strong ambition to enhance and expand its performance. However, the challenges of running trials with traditional paper documents and Excel spreadsheets made scaling difficult. Faced with these challenges, they resolved to upgrade and transition from paper-based management to streamlined electronic site operations processes.
Recognizing the pivotal role that eSource technology could play in this transition, the team was acutely aware of the importance of selecting a best-in-class technology partner. Their vision was to pave the way for their clinical trials to thrive in the modern era.
The Solution
The search for a right-fit vendor was led by Lucas Litewka, director of clinical trials at UniSC. Litewka primarily sought a technology partner who would help them harness the full spectrum of benefits offered by the eSource system.
Following a comprehensive evaluation, Litewka opted for RealTime’s eSource solution. With a smooth transition and onboarding experience, UniSC was able to rapidly scale its operations with confidence. The tangible advantages of incorporating RealTime-eSource became evident almost immediately.
“After scanning a few U.S. and Australian sites,” says Litewka, “RealTime was the strongest contender.”
Lucas Litewka, Director of Clinical Trials
University of the Sunshine Coast
The Results
Enforced Protocol Compliance
eSource offers improved control, oversight and data traceability. Upon adopting RealTime’s eSource, the UniSC team immediately recognized that a centralized eSource system helped maintain compliance with regulatory requirements.
“RealTime-eSource definitely reduces the number of errors in visits, making it virtually foolproof for coordinators to avoid errors,” says Jessica Baird, operations manager across three UniSC site locations. “With eSource, the protocol has already been clearly translated electronically. The details and order of execution are already built out in the eSource template. And alerts and notifications within the system make it impossible for our coordinators to miss anything.”
Using eSource, the team successfully streamlined data entry, reducing the need for manual data transcription and data cleaning efforts. This increased the efficiency of data management and analysis, compelled compliance and improved data quality across studies.
Centralized eSource
The eSource workflow significantly enhanced efficiency for UniSC. Centralization ensures that all study sites are using the same version of study documents, reducing confusion and maintaining consistency. UniSC’s traditional process required the team to be physically present for collaborative work on a paper document. Next, that document would then need to be circulated among various coordinators and investigators for review. With RealTime-eSource, the UniSC team can seamlessly collaborate and access study data in real-time, enabling quicker decision-making and monitoring of trial progress.
“We spent hours manipulating and managing paper documents. Whereas now, with eSource, our source templates are built quickly, and changes, if required, are just seamless,” explains Baird.
Reduced Administrative Site Burden
RealTime-eSource further eased administrative burdens so site staff could have greater focus on clinical activities. Before RealTime, each coordinator handled only three studies. But with RealTime-eSource, they can now handle between five and seven.
“Looking back at how we operated before implementation,” remarks Brendan Boyd, manager of clinical trial technologies & data at UniSC. “I can’t imagine the workload required to manually review paper-source at the scale we are operating at now.”
Principal Investigators (PIs) assume complete responsibility for total oversight of a clinical trial. Because errors are minimized, RealTime-eSource removes significant burdens from PIs and coordinators. Electronic records maintain detailed audit trails, allowing for easy tracking of data changes and ensuring data integrity. With eSource, PIs can have greater confidence that the protocol is being executed with precision, and coordinators can have less anxiety about making mistakes.
Cost Savings Through Paper Reduction
Over the long term, eSource systems lead to cost savings by reducing the need for paper-based data management, physical storage, and data cleaning efforts. In addition to increased efficiencies, UniSC has also been able to put some of its physical space to better use. Today, their former archive room, which had been piled high with binders and other paper records, is now a lab.
“Paper source requires storage for 15 years – and it all needs to go somewhere,” Boyd points out. “Being able to use our space in a better way for us and patients is a big benefit.”
Enables Remote Monitoring
Another benefit of eSource is that it allows for remote site monitoring, reducing the need for frequent CRA physical site visits and associated costs. There were many lessons learned during the pandemic. Reflecting on recent years, Litewka underscores the significance of this period, which served as a true litmus test for their operations and resilience.
“Our partnership with RealTime proved instrumental in positioning us for success during this challenging time,” Litewka emphasizes. “It enabled remote monitoring and inspection, and sponsors experienced seamless, real-time data collection without delays.”
Scaling Site Operations Management
A best-in-class eSource system often integrates with other clinical trial management systems to further streamline data flow and reduce duplication. UniSC further leverages other eClinical products within RealTime’s product suite to scale their site operations management. Their tech stack includes RealTime’s CTMS and eDocs solutions. Replacing paper workflows with technology, the team significantly increased their capacity to complete more visits. Since adopting RealTime, UniSC has recorded a staggering 2850% increase in revenue over the last five years.
“The number of visits we completed in the 2018 calendar year was 276. Today, using RealTime across the site network, we conducted 6,217 visits in 2022,” Boyd says. “As of early August, we’ve already surpassed that 2022 number.”
- Key Takeaways
Technology-enabled sites that adopt RealTime outperform their paper-based peers. The benefits of RealTime-eSource makes the system an invaluable tool in modern clinical trial management, ensuring compliance, improving data quality, efficiency, and overall study outcomes. Benefits include:
- Enforced protocol compliance
- Centralized eSource for better collaboration
- Reduced administrative site burden
- Cost savings through paper reduction
- Enables remote monitoring
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