Independent oversight to protect your trial
Clinical trials involve an extreme level of operational complexity. As a sponsor, you are responsible for the integrity of the data generated by your third-party vendors, as well as for human subject protection. That’s why regulatory agencies are now focused on how sponsors oversee the activities and ensure the quality of their CRO’s work.
Beaufort’s Clinical Monitoring Oversight service provides a layer of added security to better mitigate risks and provide early CAPA recommendations. Our experts work on-site to collect actionable data and deliver real-time metrics designed to achieve early process improvement and keep your trial on track. Beaufort’s proven process identifies and eliminates non-conformances that jeopardize trial data or subject projection. Our primary purpose is to ensure the acceptability of your trial for regulatory submission.
The value of Clinical Monitoring Oversight
Oversight Monitoring adds a lot of value because – in a way – it’s an extension of the sponsor. It adds eyes and feet on the ground at the study sites. You actually get to see how the study is really operating and what’s going on.
– Sr. Director Business Operations and Clinical Development, Moderna Therapeutics
I can tell you that at our company, we really leverage Beaufort’s clinical monitoring oversight services, and they’ve helped ensure our BIMO inspection success. A masterpiece.
– Vice President, Quality, Merck
Beaufort’s clinical monitoring oversight provides exactly the type of feedback we need regarding CRO performance.
– Director, Study Site Engagement, Takeda Pharmaceuticals
Innovation at work
Beaufort was an early innovator in the area of Clinical Monitoring Oversight, and that momentum has continued throughout our 40+ clinical clinical monitoring oversight projects with some of the world’s leading health science companies.
Our Clinical Monitoring Oversight Process
Beaufort develops a comprehensive Monitoring Plan that documents the key methodologies for evaluation and associated timelines for all activities. Risk assessment and mitigation strategies are key components of the Monitoring Plan.
Strategic Site Selection
Our rigorous site selection process is based on quantifiable analyses of key criteria including data quality, enrollment rates, CRA issues, and geographic dispersion. Strategic and targeted site selection is critical to maximize trial performance.
On-site Performance Evaluation
Our team of assessors perform on-site visits to observe, critically evaluate, and provide unbiased feedback on CRO/CRA processes and site activities. We recommend immediate on-site CAPA when necessary as we assess “metrics that matter” including PI oversight, protocol adherence, and subject protection.
Real-time Metrics and Analysis
We provide a comprehensive analysis of high-risk issues utilizing quality by design (QbD) concepts and ICH principles of risk management. Data from numerous assessment tools (including immediate reporting after each site visit) are integrated into a data warehouse so the sponsor can view customized data queries and trending analyses in real time using our online dashboard tool.
End-of-Trial Reporting and Inspection Readiness
Beaufort’s final report is a highly-detailed independent assessment of global trial conduct, and demonstrates to regulatory agencies that you conducted proper oversight of your CRO’s activities. This reporting ensures our clients are well-prepared for regulatory inspections.
Quality oversight for your global trial
Our team of highly experienced assessors understands the cultural diversities and distinct clinical approaches that come into play in an international clinical trial. In addition to GCP expertise, Beaufort assessors have extensive knowledge of international regulatory expectations and quality standards, as well as differing regional standards of care. Our team continues to receive in-depth training in relevant quality methodologies through Beaufort’s continuing education program.
Let us help you improve your clinical trial quality
Learn how Beaufort can help you meet regulatory mandates, secure and protect your clinical trial, ensure inspection readiness and improve speed to market.