As a pharmaceutical or medical device sponsor, you are responsible for the integrity of the data generated by your third-party vendors. That’s why regulatory agencies are now asking how sponsors oversee the activities and ensure the quality of their CROs. Beaufort provides an independent assessment of CRO and other vendor performance, resulting in opportunities for early process improvement and resultant cost and time savings.
Independent Assessment to Ensure the Integrity of Clinical Trial Data
Sponsors are ultimately responsible for the integrity of the data generated by their third-party vendors. Beaufort eliminates the inherent bias that may exist in a long-term relationship between a sponsor and its CRO through objective assessment of CRO work activities.
Better Adherence to Trial Plans to Reduce Regulatory Noncompliance
Beaufort’s metrics-driven quality oversight reports conﬁrm the CRO’s adherence to trial plans, which helps reduce the risk of protocol deviations and regulatory nonconformances.
Real-Time CAPA to Prevent Delays and Reduce Costs
Beaufort identifies and documents nonconformances and process inefficiencies early in the clinical trial, enabling CAPA to be implemented sooner, resulting in improved CRO efficiency, reduced costs and fewer delays.
Quality of Work Ensured to Demonstrate Commitment to CRO Oversight
When regulatory agencies ask about oversight of your CRO, you can tell them that your process is aligned with their expectations and that oversight was performed by a reputable, experienced third-party provider — Beaufort.
Our team of highly experienced quality oversight assessors understands the cultural diversities and distinct clinical approaches that come into play when working on an international clinical trial. In addition to GCP expertise, many Beaufort assessors have extensive experience in good manufacturing practice (GMP) principles and bring GMP-quality methodology to the clinical process. Our quality oversight team continues to receive in-depth training in relevant quality methodologies through Beaufort’s continuing education program.
Beaufort was the first to develop an independent quality oversight program. Our solutions are well-aligned with the FDA’s Clinical Trials Transformation Initiative (CTTI) and its call for the industry to be more innovative in its clinical trial work. Beaufort provides an independent assessment of CRO and other vendor performance, resulting in opportunities for early process improvement and resultant cost and time savings.
Quality Oversight, Step by Step
Quality Oversight Plan
Beaufort begins with the development of a quality oversight plan. Risk assessment and mitigation strategies are key components of the plan. Developed in consultation with the sponsor, the plan documents the key processes for assessment and outlines the methods and timelines utilized in performing those assessments.
Strategic Site Selection
Selection of speciﬁc sites isn’t arbitrary, but depends upon individual sponsor and trial requirements. Beaufort works closely with the sponsor to develop a quantiﬁable analysis and selection plan that includes criteria such as enrollment rates, data quality, individual CRA issues and geographic dispersion.
Assessment and Data Gathering
Beaufort quality oversight assessors observe, critically assess and provide objective and unbiased feedback on your CRO’s processes at clinical trial sites. Beaufort assessors incorporate immediate on-site CAPA when necessary to uphold subject safety. In addition, they provide clariﬁcation on protocol-speciﬁc guidelines and monitoring plans.
Metrics and Reporting
Beaufort provides real-time metrics through regular reports on the CRO work process. Used to drive CAPA, Beaufort reports contain a comprehensive, quantifiable analysis of high-risk issues utilizing quality by design (QbD) concepts and ICH principles of risk management. Data from numerous assessment tools are integrated into a data warehouse so you can view customized data queries and trending analyses in real time using Beaufort’s online dashboard tool.
End-of-Trial Reporting and Inspection Readiness
Beaufort quality oversight clients are well prepared for FDA inspections. A detailed quality oversight report demonstrates to the FDA and other regulatory agencies exactly what you did, through third-party quality oversight. This ensures that the CRO(s) provided services according to contractual and regulatory requirements.