Beaufort CRO

The regulatory landscape for medical devices, including in vitro diagnostics, in the UK is undergoing a significant transformation. This article by Karin A. Hughes, Ph.D. outlines key updates to the UK’s future medical device regulations and how regulatory professionals should do now. At Beaufort, we offer extensive expertise in IVD regulatory affairs, clinical research, quality management, and market access. Our team of regulatory experts can help in the following areas: ? - Develop & Implement PMS Systems - Prepare for UKCA Marking - Regulatory Gap Analysis & Compliance Strategy - Regulatory Submission Support - Performance Evaluation Support - Training & Consultation Read our article for details -- and contact us for more information on how Beaufort can support your UK regulatory strategy #RegulatoryAffairs #MedicalDevice #IVD

We are pleased to announce that Nilufer Celenk has joined Beaufort as our Vice President of Clinical Program Management. https://lnkd.in/gzADQ_8v Her appointment reflects our ongoing commitment to delivering best-in-class CRO solutions to help life science innovators bring their products to market. ? In this new position, Nilufer will oversee all clinical program management functions, optimizing trial execution and aligning cross-functional teams to ensure seamless program delivery. Her proven track record of driving efficiency, accelerating timelines, and delivering high-impact results reinforces our dedication to operational excellence and client success. ? #CROsolutions #ClinicalTrials

We look forward to engaging with industry leaders at the summit and discussing how our comprehensive CRO solutions can contribute to the success of your next oncology clinical trial. Our clinical and regulatory teams have significant experience navigating the complexities of early-detection oncology clinical trials while ensuring regulatory compliance for innovative diagnostic and therapeutic approaches. If you are attending, we welcome the opportunity to connect with colleagues and collaborators to discuss the evolving landscape of precision oncology. #PrecisionOncology #LiquidBiopsy #CROsolutions

The ICH adoption of the Good Clinical Practice Guideline E6(R3) introduces pivotal updates to the ethical and scientific conduct of interventional clinical trials. Notably, the guideline emphasizes risk proportionality and clarifies roles and responsibilities among trial stakeholders, aiming to uphold participant safety while embracing innovative trial designs. At Beaufort, we are dedicated to integrating these updated guidelines into our practices, ensuring that clinical trials adhere to the highest standards of ethics and quality. By aligning with E6(R3), we offer sponsors the assurance that their trials are conducted with enhanced efficiency, regulatory compliance, and a steadfast commitment to participant well-being. For a comprehensive overview of the E6(R3) updates and their implications, we invite you to read our latest blog post by our Senior Vice President of Global Regulatory and Quality,?Karin A. Hughes, Ph.D.:? https://lnkd.in/eZaMdWCx #ClinicalTrials #ICH #GCP #E6R3

Our SVP & CTO, Bill T., was invited to join Medrio’s Early Adopter Program advisory committee, where he played a key role in guiding the development of their new AI-enabled reporting. This collaboration reflects Beaufort's commitment to advancing clinical research through innovation, working to create solutions that empower trial teams and accelerate insights. We’re proud to have contributed to this effort and excited to see Medrio bring this technology to the industry. Kudos to their team on this launch! You can read more here: ? https://lnkd.in/gBvkwRRT #ClinicalResearch #Innovation #AI #Collaboration

We’re excited to share a recent Q&A with MPO Magazine, where?Karin A. Hughes, Ph.D., Senior Vice President of Global Regulatory & Quality,?Bill T., Senior Vice President and Chief Technology Officer at Beaufort, speak to the expanding role of digital technologies in transforming MedTech clinical trials: ??What digital technologies are shaping clinical trials, and how can they improve efficiency, data accuracy, and timelines? ??How do patients and clinicians respond to these technologies, and what impact do they have on participation, compliance, and trial outcomes? ??How can sponsors leverage digital tools to enhance trial awareness, recruitment, and inclusivity? ??What role does regulatory guidance, like FDA’s PCCPs for AI-enabled devices, play in using digital technologies effectively? This Q&A provides insights on leveraging innovative digital tools to optimize clinical trials, improve patient engagement, and meet regulatory expectations — essential reading for sponsors navigating the complexities of today’s MedTech landscape. Read the full interview:? https://lnkd.in/ekBBespP At Beaufort, we’re passionate about partnering with sponsors to drive impactful results and advance the future of MedTech clinical trials. #MedTech #ClinicalTrials #DigitalInnovation?

Members of Beaufort’s Clinical Monitoring Oversight?and Clinical Operations?teams will be attending the upcoming SCOPE Summit in Orlando. John Wilson, Trish Landry, and?Nilufer Celenk?look forward to connecting and sharing how our range of business solutions can help optimize the integrity, accuracy, and efficiency of your current or future clinical trials. If you’d like to schedule a meeting and learn more, please send us a message. #SCOPEsummit

The EU COMBINE Project was established in 2023 to understand and?address the complex regulatory challenges?in conducting combined studies involving medicinal products, medical devices, and IVDs. The initiative aims to streamline combined studies, foster collaboration, and reduce the regulatory burden on sponsors. In December, COMBINE reached a major milestone with EU Member State endorsement of its Phase 2 implementation strategy—marking a significant step toward making the European Union, once-again, an attractive region to conduct combined studies. Curious about how these advancements are shaping the future of clinical trials in the EU? Read our article by Karin A. Hughes, Ph.D., SVP of Global Regulatory & Quality, to learn the latest details of the project and how Beaufort helps sponsors navigate regulatory challenges, reduce barriers, and accelerate timelines to bring innovations to market. #EUCombine #RegulatoryStrategy #ClinicalTrials

Heading to JPM next week? Our senior team will be there — drop us a message and let's meet. We're excited to share how our Clinical Monitoring Oversight solutions can drive success for your next clinical trial. We work with healthcare innovators to ensure site & CRO/CRA performance, protocol compliance, and data integrity across all phases of your clinical development. Whether you're in planning stages, scaling operations, or addressing complex trial challenges, our team delivers tailored solutions that enhance quality and efficiency. Don’t miss this opportunity to collaborate with a partner committed to your trial’s success. ?? Contact us to schedule a meeting. #JPM2025 #ClinicalMonitoringOversight #ClinicalTrials?

From all of us at Beaufort, happy?holidays and best wishes for a joyous and prosperous 2025!