Beaufort brings substantial oncology CRO expertise to each cancer-focused trial, combining deep therapeutic knowledge with regulatory insight and operational excellence.
Our specialized oncology team combines decades of experience with patient-centric trial design and cutting-edge biomarker strategies. We navigate complex regulatory pathways and employ adaptive trial methodologies to maximize efficiency without compromising scientific integrity or patient safety.
Our oncology specialists design trials for diagnostic, imaging, surgical, and therapeutic devices used in cancer care. We develop protocols that effectively validate technology performance in clinical oncology settings while navigating the unique regulatory requirements and endpoints appropriate for oncology-focused medical devices.
Our regulatory team develops strategic pathways for oncology medical technologies through FDA, EU MDR/IVDR, and international frameworks. We prepare comprehensive submissions addressing the specific clinical evidence requirements for cancer-focused diagnostic, monitoring, and treatment devices.
Our data teams implement targeted approaches for analyzing diagnostic accuracy, clinical performance, and patient outcomes for oncology medical technologies. We establish appropriate reference standards, technology comparison metrics, and clinical endpoint assessments specific to cancer detection and monitoring devices.
Our quality processes ensure robust validation of oncology medical technologies through standardized specimen handling, reference standard confirmation, and appropriate blinding procedures. We implement tailored approaches to quality management focused on the critical aspects of diagnostic and device performance in cancer applications.
Thank you for your support with preparing the updated statistical analyses for our FDA 510(k) submission on the OncoMate PCR-based oncology screening test. We have had a great experience working with Beaufort and I already recommended you to several of our vendors.
Beaufort combines scientific expertise with innovation to deliver compliant oncology trials designed to accelerate breakthroughs in cancer care.
Beaufort’s oncology trials encompass patients across the full spectrum of demographics, disease stages, and treatment histories. We have established expertise in recruiting populations, including elderly patients, pediatric cases, and diverse ethnic communities. Our strategic site identification process has proven exceptionally effective for niche population studies, including rare tumor subtypes and specific molecular profiles.
Get answers to common questions about oncology-focused trials and clinical research services.
As an oncology CRO, we implement multi-faceted strategies, including advanced pre-screening algorithms, molecular profiling partnerships, and targeted site selection based on historical performance with specific cancer types. Our approach combines database mining, referral network optimization, and patient-friendly protocol design to enhance recruitment while maintaining data quality.
We develop comprehensive biomarker strategies that include central laboratory standardization, site training on sample collection protocols, and coordination of real-time biomarker testing. Our teams manage the complex logistics of specimen handling while implementing backup strategies to minimize screen failures and expedite enrollment.
Our regulatory team maintains close engagement with the FDA’s Oncology Center of Excellence and international agencies to navigate evolving endpoint requirements. We have successfully implemented novel endpoints, including minimal residual disease (MRD), pathological complete response (pCR), and various surrogate markers, with strategic documentation to support regulatory acceptance.
Our dedicated oncology monitors bring therapeutic expertise to verify complex eligibility criteria, ensure accurate response assessments, and maintain protocol compliance. We implement risk-based monitoring approaches tailored to oncology-specific challenges while providing specialized support for sites managing complex procedures and advanced treatment modalities.
We implement comprehensive site training programs on immune-related adverse event (irAE) recognition and management, supported by detailed safety monitoring plans and expedited reporting processes. Our medical monitors provide 24/7 support for irAE assessment, with tailored documentation tools to ensure consistent grading and management across study sites.
