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.