Clinical Monitoring Oversight to protect the success of your trial

Reviewing diagnostic presentation

Ensure confidence in your trial quality and data integrity

As a sponsor, you are responsible for the integrity of the data generated by your vendors, as well as for the rights, safety, and protection of human subjects. That’s why regulatory agencies are increasingly focused on how sponsors successfully oversee the activities and ensure the quality of their CRO’s work.

Beaufort’s Clinical Monitoring Oversight provides sponsors with a layer of added security and oversight by objectively evaluating and assessing the performance, quality, and compliance of all site activities and site staff. Our local oversight monitors conduct on-site visits to collect actionable data designed to mitigate problems quickly, ensure the integrity of all data, and help keep your trial on time and on budget. Beaufort’s proven processes help identify and eliminate non-conformances that can jeopardize trial data or subject projection.

Our primary purpose is to provide sponsors with confidence, clarity, and consistency across all clinical activity and ensure the acceptability of your trial for regulatory submission.

Contact Us

Flexible solutions to meet your unique needs

  • Full Service Clinical Monitoring Oversight

    Full Service Clinical Monitoring Oversight

    Full Service Clinical Monitoring Oversight

    Comprehensive on-site monitoring and reporting, with objective and actionable data and early CAPA recommendations to ensure that your trial is on track and prepared for regulatory submission and inspection.

    Contact Us
  • Co-monitoring Solutions

    Co-monitoring Solutions

    Co-monitoring Solutions

    On-site evaluation of site and trial staff performance to review and verify all activities align with the study protocol and monitoring plan.

    Contact Us
  • Crisis Remediation

    Crisis Remediation

    Crisis Remediation

    On-demand response and corrective assistance in critical quality situations to protect the viability and integrity of your trial.

    Contact Us

Local on a global scale

Beaufort’s team of local monitors live and work in over 50 countries around the world — meeting the needs of sponsors when and where you need them. We bring a deep understanding of the regulatory expectations and quality standards that come into play in an international trial, as well as extensive hands-on knowledge of the distinct clinical approaches that exist on a local level. This depth of experience allows for proactive planning to properly address:

  • National regulatory nuances
  • Local languages and dialects
  • Cultural and population insights
  • Infrastructure considerations

Our Clinical Monitoring Oversight Process

 

Clinical Monitoring Oversight Plan

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.

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.

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.

The value of Clinical Monitoring Oversight

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 clinical monitoring oversight and assessments.

Thought Leadership

Discover insights from Beaufort on the evolving Clinical Monitoring Oversight landscape.

Blog

Eliminating Data Blind Spots with Clinical Monitoring Oversight. Q&A with SVP, Chief Quality Officer, John R. Wilson, Jr. … Read more

Webinar

What data alone won’t tell you: The rising value of Clinical Monitoring Oversight. See how sponsors can protect … Read more

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.