BEFORE
TrueBlue Clinical Research Before RealTime
- Inefficient processes using paper
- Disparate spreadsheets for managing finances
- Hard copy files and costly physical storage
AFTER
TrueBlue Clinical Research
- Time and cost savings via streamlined digital processes
- One source of truth for finance management
- Digital platform with unlimited storage
Overview
TrueBlue Clinical Research is a growing clinical research organization based in Tampa, Florida with plans to expand into other locations as well. While they began as a site with paper-based processes, TrueBlue knew that faster growth would come from harnessing the power of technology and driving efficiencies every step of the way.
For over 10 years, TrueBlue has been utilizing RealTime’s integrated eClinical solutions to manage and streamline their clinical trial processes. As an organization, TrueBlue has already experienced incredible growth, including an acquisition and rebrand in 2022, and looks forward to continuing the expansion of their research capabilities and facilities.
The Challenge
The Limitations of Paper-Based Systems
As a community-based site looking to expand their reach throughout the Tampa metro area and beyond, TrueBlue realized that relying on paper-based processes had become a significant hurdle in managing their growing number of studies. With more studies, patients, and finances to track, the inefficiencies of manual documentation and data entry were clear. Coordinating across multiple studies paired with the time-consuming nature of updating and sharing paper records made it difficult to keep stakeholders aligned. With paper also came the expense of long-term storage, time spent looking for lost or misfiled documents, and the risk of errors and costly delays.
Regulatory Challenges and Data Accuracy Concerns
Moreover, regulatory compliance and data accuracy became growing concerns for TrueBlue. Their reliance on paper-based workflows and unwieldy regulatory binders made managing governing documents and protocol adherence more difficult. Too much time was being spent handling paper documents and disparate spreadsheets rather than focusing on patients and studies. The limitations of TrueBlue’s paper-based system were not only hindering the scalability of their operations – they were also impacting the quality and speed of their studies and research outcomes.
The way forward was clear: harnessing technology to accelerate and modernize their processes.
The Solution
TrueBlue adopted RealTime’s integrated eClinical platform to streamline and centralize their clinical trial processes, effectively addressing the inefficiencies and risks that came with their previous paper-based system. Starting with CTMS, TrueBlue has now expanded to use the entire RealTime-SOMS product suite, which includes eSource, eReg/eISF, Engage! (MyStudyManagerTM Participant Portal + eConsent), Pay, Text, and Mobile App. Since 2021, TrueBlue has also leveraged the RealTime-Devana business intelligence platform for pipeline management and automated study start-up.
RealTime’s easy-to-use electronic platform has freed up valuable time for TrueBlue, allowing the team to achieve greater productivity with the same number of employees. No longer burdened by slow, paper-based methods, coordinators, investigators, and administrative staff alike can do more in less time – creating the efficiency and impact of a larger team. The shift to real-time data tracking and electronic workflows has also provided greater transparency, enabling teams to collaborate more effectively and to make informed decisions faster. Altogether, these improvements and efficiencies have been key to supporting TrueBlue’s future growth as a multi-site research organization.
“We’ve done more studies with the same team by essentially leveraging the
RealTime system as extra employees.”
Jeffrey Smyth, President and Executive Director
TrueBlue Clinical Research
The Results
By implementing RealTime’s centralized and automated platform, TrueBlue was able to streamline study management, improve data integrity, and enhance compliance across all their studies. Critical data and document management is now seamlessly covered by the system, including eSignatures, quality control processing, action items, reminders, and more. From study pipeline to patient recruitment and closeout, RealTime-SOMS accelerates TrueBlue’s clinical trials every step of the way.
CTMS – Improved Trial and Patient Management
RealTime-CTMS centralizes all aspects of trial management. By streamlining workflows, automating key tasks, and providing real-time access to critical data, CTMS helps reduce TrueBlue’s administrative burden, improve accuracy, and ensures that timelines and budgets are met. It also boosts communication and coordination across teams – enabling TrueBlue to more efficiently manage multiple studies and share best practices while maintaining high standards of compliance and data quality. CTMS has also improved TrueBlue’s invoice and finance management, providing an effective snapshot overview to help with planning and oversight. Since implementing RealTime-CTMS to track and manage their recruitment efforts, TrueBlue has established a consistent recruitment rate of 94% and overall retention rate of 90%.
eSource – Streamlined Data Capture and Storage
By capturing data directly at the point of care, RealTime-eSource eliminated the need for paper while also enhancing accuracy, reducing the risk of transcription errors, and allowing for real-time data access and updates. This not only improves the efficiency of TrueBlue’s study workflows, but also accelerates data review and query resolution. Additionally, eSource simplifies regulatory compliance by securely storing records and providing audit trails.
TrueBlue’s eSource process has saved considerable time over the years, resulting in an established 24-hour timeline for eSignatures and internal data quality control. Compared to spending multiple days getting a physical signature with their previous paper-based methods, let alone other important tasks, these substantial time savings have increased staff capabilities for handling more trials.
eReg/eISF – True Audit Preparedness
RealTime’s eReg/eISF platform digitizes the management of TrueBlue’s regulatory documents, eliminating physical binders and simplifying what was once a complex and time-consuming process. By centralizing all essential documents such as IRB approvals and informed consent forms with RealTime’s eReg/eISF, TrueBlue now enjoys easier access, better organization, and improved compliance tracking. These features, paired with automated reminders and audit trails, reduce the risk of missing or incomplete documents and minimize the administrative burden on staff, freeing them up for other tasks.
Several years ago, TrueBlue had an FDA audit for two studies with over 100 patients each. The auditors were given access to the eReg/eISF platform and eSource, speeding the time of review. Their FDA audit resulted in zero findings. Future routine audits and reviews by sponsor CRAs have also been fast and easy thanks to RealTime’s intuitive platform and remote monitoring functionality.
With RealTime’s integrated eClinical platform, TrueBlue has not only streamlined their operations but also unlocked new levels of efficiency and excellence, enabling them to grow and thrive in an increasingly competitive industry.
“In clinical trials, the product of what we do is documentation. The data is the product. RealTime enables us to create a better product because we’re able to create high-quality data for all of our studies.”
Jeffrey Smyth, President and Executive Director
TrueBlue Clinical Research
- Key Takeaways
For over a decade, RealTime’s integrated eClinical solutions have empowered TrueBlue to scale their operations while reducing costs, minimizing delays, and delivering higher quality research outcomes. Other benefits include:
- Considerable time and cost savings over paper-based methods
- Powerful all-in-one digital platform
- Improved invoice and finance management
- Exponential growth and scalability become a reality
- Audit readiness with improved data integrity
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