Confidence, clarity, and consistency for your clinical trial

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 Independent Clinical Quality Evaluation (ICQE) 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 ICQE 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.

See Us In Action

The value of Independent Clinical Quality Evaluation (ICQE)

Objective CRO Evaluation
Objective CRO Evaluation
Demonstrate that you conducted oversight mandated by regulatory bodies through independent, unbiased assessments of all CRO activities.
Enhanced Data Integrity
Enhanced Data Integrity
Ensure all data generated by your CRO and third-party vendors align with trial protocols and regulatory guidelines.
Human Subject Protection
Human Subject Protection
Maintain the highest scientific standards that incorporate immediate on-site CAPA to rigorously uphold subject safety and protection.
Non-Conformance Prevention
Non-Conformance Prevention
Proactively identify and correct any operational non-conformances and trial deviations to prevent regulatory non-compliance and resulting delays.
Reduced Regulatory Risk
Reduced Regulatory Risk
Enable risk assessment and mitigation strategies to continuously align all processes with regulatory expectations.
Peace of Mind
Peace of Mind
Secure the integrity of your trial with an experienced leader in clinical quality evaluation and assessments.

Innovation at work

Beaufort was an early innovator in the area of Independent Clinical Quality Evaluation, and that momentum has continued throughout our 40+ clinical quality evaluation projects with some of the world’s leading health science companies.

Brand logos for the companies Moderna, Takeda, GSK, Merck, Spero Therapeutics, Visterra, and SK Life Science.
Brand logos for the companies Moderna, Takeda, GSK, Merck, Spero Therapeutics, Visterra, and SK Life Science.
Brand logos for the companies Moderna, Takeda, GSK, Merck, Spero Therapeutics, Visterra, and SK Life Science.
Brand logos for the companies Moderna, Takeda, GSK, Merck, Spero Therapeutics, Visterra, and SK Life Science.
Brand logos for the companies Moderna, Takeda, GSK, Merck, Spero Therapeutics, Visterra, and SK Life Science.
Brand logos for the companies Moderna, Takeda, GSK, Merck, Spero Therapeutics, Visterra, and SK Life Science.
Brand logos for the companies Moderna, Takeda, GSK, Merck, Spero Therapeutics, Visterra, and SK Life Science.

Our Independent Clinical Quality Evaluation (ICQE) Process

 

ICQE Plan

Beaufort develops a comprehensive ICQE Plan that documents the key methodologies for evaluation and associated timelines for all activities. Risk assessment and mitigation strategies are key components of the ICQE 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 ICQE clients are well-prepared for regulatory inspections.

Quality oversight for your global trial

Our team of highly experienced ICQE 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 ICQE team continues to receive in-depth training in relevant quality methodologies through Beaufort’s continuing education program.

An expert explains clinical trial quality insights to a group of professionals at a table.

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.