How Beaufort’s Flexibility, Operational Excellence & Technical Expertise Drove Success for a Multicenter ICU Study
Overview
A leading global in vitro diagnostics manufacturer partnered with Beaufort to conduct a prospective, multicenter, observational clinical study in Intensive Care Unit (ICU) settings across the United States. The objective of this study was to validate a diagnostic assay in adult ICU patients diagnosed with moderate to severe kidney disease. The targeted enrollment for this study was approximately 500 adult ICU subjects across 20 clinical sites in the United States. All participants were required to have documented moderate or severe AKI at the time of enrollment (Kidney Disease: Improving Global Outcomes [KDIGO] AKI Stage 2 or Stage 3).
Project Deliverable
Beaufort was engaged to comprehensively manage the clinical study, encompassing all phases from initial site qualification and activation to final close-out activities. Beaufort led the site selection, site initiation visits, ongoing site management, clinical trial monitoring, close-out activities, and supported Institutional Review Board (IRB) submissions and communications.
Beaufort Results
Through continuous collaboration with sites, a cohesive working relationship with the Sponsor, and a results-driven approach, Beaufort achieved the following outcomes:
- Enhanced Monitoring & Data Integrity: Through a combination of on-site and remote site visits, site training, and technology-enabled assessment tools, Beaufort ensured a robust data set for the study while maintaining protocol integrity across all sites.
- Expedited Data Processing: By completing 100% source data verification two months ahead of schedule, Beaufort accelerated the timeline for data adjudication and database lock, facilitating quicker access to critical study results.
- Effective Site Partnerships: Our collaborative relationships with clinical sites ensured the smooth study execution as well as positioned Beaufort as a trusted partner for future research endeavors – further expanding our global site network.
Study Challenges & Solutions
Beaufort encountered and successfully mitigated challenges during the study start-up and enrollment phases of the project, including:
Site Start-Up:
The project commenced during the COVID-19 pandemic, which caused delays in site activation as healthcare providers prioritized immediate patient care. Key challenges encountered during site activation included resource limitations at clinical sites, and adjustments to site research management policies due to pandemic-related policy changes. Beaufort implemented the following solutions to ensure the project stayed on track:
- Proactive Communication: Through the extended site start-up phase, maintained regular and concise communication with the site Principal Investigators (PIs) and study teams, ensuring alignment and readiness despite evolving priorities.
- Flexible Support: Adapted to the shifting needs of the sites by offering tailored support, including flexible scheduling and virtual start-up meetings and training, which accommodated pandemic-related constraints.
- Digital Innovation: Leveraged technology to streamline processes, implementing electronic Site Binders, DocuSign for compliant electronic signatures in accordance with 21 CFR Part 11, and secure FTP sites for document sharing, facilitating efficient site activation in a remote environment.
- Client Focused: Worked closely with the Sponsor to adopt multiple teleconference platforms, ensuring seamless communication to accommodate different institutional preferences and minimize disruption during site start-up.
Subject Eligibility Determination:
To ensure consistent application of KDIGO staging criteria across diverse clinical sites, despite potential variations in standard practices during screening and subject eligibility, Beaufort implemented the following solutions:
- Streamlined Enrollment Process: Collaborated with the Sponsor to help efficiently guide sites through a clear and standardized eligibility assessment against a defined enrollment timeline.
- Enhanced Protocol Compliance: Developed a tool set that not only streamlined the screening process, but helped minimize protocol deviations and enabled sites to make timely, data-driven enrollment decisions, thus improving overall study efficiency.
Informed Consent:
Obtaining fully documented Informed Consent from Legally Authorized Representatives (LARs) for ICU patients within the short protocol window presented challenges. Beaufort addressed this by:
- Digital Consent Solutions: Partnered with the Sponsor to implement electronic Informed Consent processes at sites where traditional methods were impractical, ensuring compliance with U.S. Federal Regulations and protocol criteria.
- Streamlined Workflow: The use of electronic tools expedited the consent process, minimized delays, and ensured that all documentation was completed within the narrow protocol enrollment window, enhancing overall study efficiency.
Data Verification:
Maintaining data integrity through rigorous review of KDIGO staging during remote clinical monitoring activities was critical. Beaufort implemented the following solutions:
- Specialized On-Site Support: Deployed Subject Matter Experts (SMEs) to work closely with site staff, providing real-time guidance and review of the data entered into the validated tool, ensuring accuracy from the outset.
- Collaborative Monitoring: Integrated SMEs with Clinical Research Associates (CRAs) to support the review of the KDIGO staging data during monitoring preparation, and regularly trained and prepared sites to focus on achieving monthly enrollment targets.
- Efficient Data Management: Implemented an FTP site for sites to upload deidentified Source Documents and data for Beaufort CRAs to source data verify.
Study Communications:
To foster engagement with PIs and site staff during a time when on-site visits were not feasible, Beaufort employed the following creative communication strategies:
- Sustained Outreach: Maintained high levels of engagement with PIs and site staff through consistent and creative digital communication, including study newsletters, interactive weekly e-blasts, and virtual investigator meetings.
Beaufort’s comprehensive management of this multicenter ICU study exemplifies our flexibility and approach to overcoming complex challenges while maintaining high standards of data integrity, protocol compliance, and operational efficiency. By leveraging innovative digital solutions, fostering strong site relationships, and adapting to the evolving landscape during and after the COVID-19 pandemic, we delivered the project ahead of schedule and ensured the study’s success. Our proactive, client-focused approach not only met the sponsor’s objectives but also positioned Beaufort as a trusted partner for future support.
With proven expertise across various clinical settings, we are committed to helping diagnostic innovators accelerate development and bring life-changing technologies to market.
Learn more about how Beaufort can successfully support your current or future clinical trial.
Beaufort steps in mid-study and delivers comprehensive data management, robust safety monitoring, and expert statistical analysis.
Overview
Spectral Medical Inc., a late-stage theranostic company specializing in sepsis and septic shock therapies, engaged Beaufort to support a prospective, multicenter, randomized, open-label clinical trial. The trial evaluates the efficacy and safety of including a PMX (Polymyxin B Hemoperfusion) cartridge in the standard care regimen for patients with endotoxemic septic shock. The outcomes of patients receiving standard medical care alone are compared with the outcomes of patients treated with standard medical care combined with the PMX cartridge. Participants are randomly allocated to a treatment arm, with the experimental arm receiving treatment with TORAMYXIN PMX-20R, an extracorporeal PMX cartridge that selectively removes endotoxin through direct hemoperfusion of circulating blood.
Project Deliverable
Spectral turned to Beaufort mid-study to address growing data complexities and integrate
previously managed data under a more efficient and comprehensive system. This involved the
transfer of the pre-existing study data to a new Electronic Data Capture (EDC) system built by the
Beaufort data team. Beaufort also worked closely with the study’s Independent Safety Assessment
Committee (iSAC), providing feedback and analysis to support planned safety data.
Beaufort Results
Beaufort’s engagement yielded critical improvements and ensured the study maintained the
highest data integrity and participant safety. Through continuous collaboration with sites, the
safety committee, and the Sponsor, Beaufort achieved the following outcomes:
Innovative EDC Development:
Beaufort developed a custom EDC system that would mimic the basic structure of the existing EDC and incorporate randomization and safety data which had previously been managed through separate systems. The EDC also integrated data from a sub-study which was captured through paper records. By creating a system that was more standardized and modernized, Beaufort ensured a smooth data transition without compromising integrity.]
Comprehensive Data Verification:
Beaufort’s data science team worked diligently to verify all active queries in the existing EDC to demonstrate the accuracy of previously generated data. The team leveraged their extensive experience to efficiently and competently confirm query functionality.
Seamless Data Transfer with Rigorous Quality Control:
The transfer of pre-existing data into the newly developed EDC required meticulous planning. Beaufort executed a test transfer to anticipate potential issues and implemented a one-week freeze on new data input to facilitate a clean transition. Additionally, all manually input data was systematically examined by Beaufort’s team and underwent 100% quality control to ensure the original data was preserved
Data Modernization and Standardization for Improved Efficiency:
The original EDC used non-standard formatting that couldn’t easily be integrated with other EDCs. Beaufort re-engineered the new EDC to modernize outdated medical coding and formatting, aligning with current industry standards, enabling better interoperability and future-proofing data management. All data sets impacted by these improvements underwent 100% QC to maintain data integrity.
Comprehensive Training and Support for EDC Implementation:
To ensure smooth adoption of the new EDC system, Beaufort provided hands-on training to sites, coordinators, and the Spectral team. This empowered all stakeholders to efficiently manage trial data on the custom EDC, ensuring all stakeholders could comfortably and competently manage data using the new system and minimizing any disruption to the ongoing study.
Intensive Focus on Safety Monitoring and Statistical Analysis:
Beaufort’s Pharmacovigilance team played a pivotal role in safety monitoring, providing the iSAC with the data they needed for regular reviews. Beaufort’s Biostatistics team utilized advanced statistical methodologies and rigorous data analysis to ensure that patient safety remained at the forefront of the trial.
- Generation of Tables, Listings, and Figures (TLFs): To support the iSAC’s safety evaluations, Beaufort generated clear and concise TLFs, providing visual representations of safety trends and endpoints based on the new EDC system and in alignment with the iSAC charter. These reports allowed for easy interpretation by iSAC members.
- In-Depth Trend and Signal Detection: Beaufort’s statisticians reviewed the data to detect trends and potential safety signals in the trial data. This early detection allowed the iSAC to address safety risks in real-time, helping to protect patient well-being.
- Regulatory-Compliant Adverse Event Reporting: All Serious Adverse Events (SAEs) were thoroughly tracked, analyzed, and reported to the Sponsor and if applicable, reported to the regulatory authorities. This ensured that the study adhered to the highest standards of compliance and safety management.
In partnership with Spectral Medical Inc., Beaufort demonstrated its ability to step in mid-study and deliver comprehensive data management, robust safety monitoring, and expert statistical analysis. Beaufort’s attention to detail and commitment to data integrity ensured the clinical trial ran smoothly, with participant safety as the highest priority. The result was a streamlined, reliable trial process that allowed Spectral to focus on advancing critical therapies for septic shock.
Learn more about how Beaufort can successfully support your current or future clinical trail.