At Beaufort, we understand your path to market can be complex. That’s why we focus on providing flexible and tailored solutions that streamline the process and ensure your unique needs are met at every step. Why Sponsors Choose Us: ? Customized, purpose-fit services ? Expertise in managing complex MedTech trials ? Integrated data sciences and technology for actionable insights ? Proven & trusted 20-year track record We’re not just a CRO. We’re your partner in success. Let us help you bring your product to market faster and smarter. #CRO #InnovativeSolutions #ClinicalTrialSuccess
Beaufort CRO
研究服务
Virginia Beach，VA 10,250 位关注者
Accelerate your path to market with our global team of MedTech experts.
关于我们
Beaufort is a global CRO built around one purpose — helping life science companies improve and save lives through the rapid development and commercialization of innovative products. Our shared interest and commitment to your success drives our entire organization to deliver best-in-class clinical trial services, regulatory strategy and planning, data and business analytics, data management and statistics, and quality services. We are: ? MedTech Focused - Industry-leading expertise to streamline your clinical development. ? IVD Specialists - Two decades of extensive diagnostic experience. ? Results Oriented - Guided by efficient and adaptive clinical trial management. ? Partnership Driven - 94% of clients rate Beaufort higher than other CROs Our experience includes: ? 500+ Regulatory Submissions including 510(k)s, PMAs, IDEs and CE-Marks ? 4,000+ Clinical Study Sites Around the Globe ? 1,000+ Clinical Trials Across a Wide Variety of Indications and Testing Platforms ? 2,600+ Clinical Professionals in Over 50 Countries See how Beaufort CRO can accelerate your medical innovation -- and put our experience to work for you.
- 网站
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https://beaufortcro.com/
Beaufort CRO的外部链接
- 所属行业
- 研究服务
- 规模
- 51-200 人
- 总部
- Virginia Beach，VA
- 类型
- 私人持股
- 创立
- 2004
- 领域
- Regulatory Affairs Consulting、Clinical Outsourcing、Quality Oversight、Clinical Trial Management、Biostatistics、Data Management、Companion Diagnostics、Medical Devices、In Vitro Diagnostic、Contract Research Organization、Clinical Trial Services、IVD CRO、Site management and monitoring、Data Analysis、Regulatory Strategy and intelligence、Regulatory Submission preparation、Genetic Research、AI / Software、IVDR consulting和CDx/complimentary
地点
Beaufort CRO员工
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Arnold Huang, PhD
Chief Business Officer at Beaufort – A Different CRO Experience | Strategic Planning | Business Transformation | Commercial Operations and…
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Paula Johnson
Senior Director, Biostatistics at Beaufort - A Different CRO Experience | Strategic Statistical Consulting | Statistical Programming | In Vitro…
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Patricia Hamilton, RN, MS
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John Wilson
**Attending SCOPE 2025** SVP, Chief Quality Officer at Beaufort | Quality Oversight | Clinical Research & Development | Regulatory Affairs |
动态
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Early cancer detection is transforming the landscape of oncology clinical trials, offering new hope for patients and driving the development of innovative diagnostic tools. As biomarkers, liquid biopsies, and AI-driven technologies continue to shape the future of early detection, Beaufort CRO stands out as a leader in supporting diagnostic manufacturers through every stage of the clinical trial and regulatory process. Read our latest article to see how Beaufort is helping to pave the way for the next generation of early cancer detection assays and continuously working toward improved patient outcomes. #EarlyCancerDetection #MCED #OncologyClinicalTrials
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We are honored to announce that Beaufort CRO has been named a finalist for the 2024 Fierce CRO Awards in the Excellence in Clinical Trial Management category. This recognition reflects our leadership and commitment to delivering impactful?and innovative trial management services for our partners. Thank you to our dedicated team and to our sponsors for entrusting us with their critical work in advancing clinical research. #FierceCROAwards #ClinicalResearch #LifeSciences
The Top CROs Leading the Way in Clinical Research – Finalists Announced https://loom.ly/7x12MGw These Contract Research Organizations (CROs) have distinguished themselves through outstanding contributions to clinical research and advancements in life sciences. Recognized for their leadership, innovation, and commitment to excellence, our finalists exemplify the highest standards in the industry. We invite you to explore the list of this year's exceptional finalists and join us in recognizing their impactful work. View the full list here. ?? https://loom.ly/7x12MGw #FierceCROAwards #ClinicalResearch #LifeSciences
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At Beaufort, we understand the intricacies of IVD and medical device trials. From oncology to infectious disease, we partner with sponsors across therapeutic areas to bring life-changing products to market.?We navigate complex protocols with strategic insights based on two decades of specialized experience, ensuring every step of your trial is on the right path for regulatory and clinical success. Let's talk about the needs of your next project. #MedTech #CRO?#ClinicalTrials
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Beaufort takes a flexible and solutions-driven approach to managing clinical studies for our clients. This was evident throughout our collaboration with a leading global IVD manufacturer on a multicenter ICU study to validate a diagnostic assay for acute kidney injury patients. Despite the unique challenges of managing a study during and after the COVID-19 pandemic, we successfully accelerated timelines and enhanced data integrity by leveraging advanced monitoring technologies, streamlining consent processes, and employing proactive site management. Our proven expertise in complex clinical environments ensured seamless execution and faster access to critical study results.? ? Let start a conversation about how Beaufort's innovation, experience, and commitment to your success can benefit your next clinical study. ? #ClinicalResearch #Innovation #StudySuccess
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October is Breast Cancer Awareness Month, and while there is still much work to be done in the fight against breast cancer, we are also witnessing remarkable advancements in cancer research and diagnostic testing. AI and machine learning (ML) and Multicancer Early Detection (MCED) tests are transforming how we identify and treat cancer, enabling faster, more accurate diagnoses, which are critical to improving patient outcomes. Beaufort is proud to support our sponsors in the development of therapeutic approaches that leverage these innovations. We’ve had the privilege of working with leading innovators in cancer research to develop novel technologies and diagnostic tests aimed at improving early cancer detection. Our focus on early-stage screening is helping to increase the efficacy of companion diagnostics and improve cancer survivorship. Our team is also at the forefront of supporting research efforts that advance the latest cell and gene therapies and liquid biopsy techniques, offering less invasive ways to monitor and treat breast cancer more effectively. During Breast Cancer Awareness Month, let's also remember the importance of regular screenings. Self-testing in addition to annual screenings with your healthcare provider can be life-saving. #NationalBreastCancerAwarenessMonth #BreastCancer #ClinicalTrials
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Successfully managing medical device and IVD clinical trials requires a strategic approach to ensure compliance, efficiency, and quality outcomes. In our latest blog post,?8 Essentials for Managing Successful Medical Device and IVD Clinical Trials, Trish Landry, SVP, Global Clinical Operations shares critical insights gained from over three decades of clinical research experience. From leveraging technology to early regulatory authority engagement, discover the key factors that contribute to successful trials and should be considered for your next project. Read more:? https://lnkd.in/es6Cpwfn #ClinicalTrials #MedicalDevices #IVD
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Read our Medical Device Case Study? https://lnkd.in/gzAB-MTF?and see how Beaufort stepped in mid-study to help Spectral Medical Inc. address growing data complexities for their prospective, multicenter, randomized, open-label trial. The result of Beaufort's engagement and our development of an innovative and customized EDC was a streamlined, reliable trial process that allowed Spectral to focus on advancing critical therapies for septic shock. September is Sepsis Awareness Month and Beaufort is proud to support therapeutic advancements in treating a disease affecting millions worldwide. #SepsisAwarenessMonth #CRO #MedicalDevice
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Our team of regulatory experts can guide you through the requirements for Stage 1 compliance of FDA's Final Rule on LDTs. Read below for insights from Karin A. Hughes, Ph.D. as well as our recent blog on effective strategies to help you prepare for upcoming deadlines: https://lnkd.in/eaWycqgu Contact us to learn more about our solutions to help maintain market access for your LDTs. #LDT #IVD #FDA
Senior Vice President, Global Regulatory and Quality at Beaufort - A Different CRO Experience | In Vitro Diagnostics (IVD) | Regulatory Affairs | Companion Diagnostics
??Preparing for Stage 1 Compliance with the FDA's Final Rule on Laboratory Developed Tests (LDTs) As we enter the budgeting phase for FY 2025, U.S. clinical laboratories may wish to begin preparing for the May 6, 2025 deadline for Stage 1 compliance with the FDA's final rule on LDTs. Over the next seven months, labs must address several key compliance challenges: ??Adverse Event Reporting: Develop standard operating procedures (SOPs) that align with the medical device reporting (MDR) requirements under 21 CFR part 803. ??Mandatory Reporting: Laboratories must report to the FDA any adverse events that reasonably suggest that a device may have caused or contributed to a death or serious injury, or that a device has malfunctioned, and this malfunction would likely cause or contribute to death or serious injury if it were to recur. ??Reporting Timeline: Most serious adverse events must be reported within 30 days, however, there are certain events that must be reported in 5 days. ??Submission Method: MDRs must be submitted electronically through the FDA's Electronic Submission Gateway, requiring laboratories to establish free accounts for the electronic submission of medical device reports. ??Complaint Files: Establish procedures for receiving, reviewing, and evaluating complaints in accordance with 21 CFR 820.198, ensuring thorough documentation and record-keeping. Understanding the information needed to complete FDA MedWatch forms is helpful to ensure collection as part of compliant processes. ??Corrections and Removals: Understand the requirements under 21 CFR part 806, which mandate that labs report any corrections or removals initiated to reduce a risk to health or remedy a violation of the FD&C Act which may present a risk to health. Develop processes for evaluating the need for such actions and documenting the rationale, as well as notifying the FDA in a timely manner. Our team consists of regulatory experts with extensive practical experience in the #IVD industry. We have developed and implemented compliant processes across a range of organizations, from startups to established IVD companies. Our hands-on knowledge, combined with a pragmatic, end-result approach, enables us to guide your laboratory through the complexities of FDA requirements in a way that is compliant yet not overly burdensome. We also recognize the overlap and distinct differences between the FDA Code of Federal Regulations and the Clinical Laboratory Improvement Amendments of 1988 (CLIA), facilitating gap analyses and ensuring that our solutions leverage existing CLIA system infrastructure. https://lnkd.in/gsp-Ky6n Beaufort CRO #LDTs #FDACompliance #RegulatoryConsulting #ClinicalLaboratories
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Join us at AMDM's IVD Focus Meeting next month. As a longtime meeting sponsor, the Beaufort team looks forward to reconnecting with industry professionals to discuss the latest regulatory challenges facing diagnostic manufacturers. Be sure to visit our table on October 17th to explore the range of solutions we offer and how we can support your product development. On October 18th, Beaufort’s SVP of Global Regulatory and Quality, Karin A. Hughes, Ph.D., and President of AMDM’s Board of Directors, will be presenting on the EU COMBINE project. We look forward to seeing you there. #LDT #CompanionDiagnostics #IVDR
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