エピソード
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🧪 Our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interview series continues this week, as Christine Santagate, RAC is joined by Lab Coordinator Craig Young of the Jordi Labs team.
👨🔬 Discover how Craig's diverse background in chemistry and project management led him to become an 𝗲𝘀𝘀𝗲𝗻𝘁𝗶𝗮𝗹 𝗽𝗮𝗿𝘁 𝗼𝗳 𝗼𝘂𝗿 𝗼𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀.
Craig shares:
✔️ His journey from WPI to Las Vegas and back to Mansfield
✔️ Experiences in biodiesel production and laboratory startups
✔️ How his "jack-of-all-trades" nature suits lab coordination
✔️ His role in implementing ClickUp for project management
✔️ Valuable advice for those entering the scientific industry
⚗️ We'll be continuing to highlight more Jordi Labs all-star team members in the coming weeks, so stay tuned.
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📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🧪 Our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interview series continues this week, as Christine Santagate, RAC is joined by Chemist II Michael Morales of the Jordi Labs team.
👨🔬 Discover how Michael's passion for chemistry led him to becoming a 𝘁𝗿𝘂𝗲 𝗲𝘅𝗽𝗲𝗿𝘁 𝗶𝗻 𝗴𝗮𝘀 𝗰𝗵𝗿𝗼𝗺𝗮𝘁𝗼𝗴𝗿𝗮𝗽𝗵𝘆.
Michael shares:
✔️ His journey through academia and into industry
✔️ The importance of perseverance in scientific research
✔️ His experience in tackling complex projects and method development
✔️ The rewards of mentoring and giving back to the scientific community
✔️ Valuable advice for those considering a career in chemistry
🔬 Check out the interview to learn from Michael's expertise and hopefully be inspired by his enthusiasm for analytical chemistry as well!
We plan to continue to highlight many more all-star employees from Jordi Labs in the coming weeks, so stay tuned.
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📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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エピソードを見逃しましたか？
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
In our third and final clinical trials video focused on data management, Senior Director of Data Operations Noel Keegan returns to speak with Jaishankar Kutty, Ph.D. about the 𝗰𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗿𝗼𝗹𝗲 𝗼𝗳 𝗖𝗥𝗢𝘀 𝗶𝗻 𝗱𝗮𝘁𝗮 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁.
Noel covers:
🤝 The importance of partnership between CROs and sponsors
🏆 Key performance and quality indicators across all trial phases
🔍 Independent quality review processes
📚 Leveraging standardized libraries and best practices
🎯 Tailoring services to meet specific sponsor needs
In the end, a CRO should act as an extension of the sponsor's team, providing expertise, accountability, and flexibility throughout the clinical trial process.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
👨🔬 Our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 short interview series continues this week, as Christine Santagate, RAC is joined by another member of the Jordi Labs team, Tommy Kumlin.
See how Tommy's background in chemistry and chemical engineering led him to become a jack-of-all-trades in analytical techniques. 🔬
Tommy shares:
✔️ His specialization in spectroscopy, microscopy, and thermal analysis
✔️ How he combines different techniques for comprehensive analysis
✔️ The satisfaction of instrument troubleshooting and maintenance
✔️ The importance of collaboration in a professional environment
✔️ Valuable advice for those entering the industry
Stay tuned as we plan to highlight additional Jordi Labs staff in the coming weeks! 🧫
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📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
🎉 The data management party continues!
Part 2 of our clinical trial data management series is here! Jaishankar Kutty, Ph.D. welcomes back Senior Director of Data Operations, Noel Keegan, to dive into the 𝗺𝗮𝗶𝗻𝘁𝗲𝗻𝗮𝗻𝗰𝗲 𝗮𝗻𝗱 𝗰𝗹𝗼𝘀𝗲𝗼𝘂𝘁 𝗽𝗵𝗮𝘀𝗲𝘀 of clinical trial data management.
In this discussion, Noel covers:
📊 Data validation activities post-database build
🔄 Managing external data from core labs, imaging, and safety
📈 Sharing validation progress with sponsors
🔒 Database lock timelines and best practices
📦 Archiving processes and considerations
💡 Key takeaway: Proactive data cleaning during the maintenance phase leads to a smoother, faster database lock!
🎬 Missed Part 1? Check out our previous video on the study setup phase of data management.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
🎉 It's a data management party – you in?
Our team had a ton of fun recording the newest video in our clinical trial video series and it's now available. Jaishankar Kutty, Ph.D. speaks with Senior Director of Data Operations, Noel Keegan, about 𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗱𝗮𝘁𝗮 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗶𝗻 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀, specifically focusing on the study setup phase.
More particularly, Noel covers selecting appropriate electronic data capture systems, database setup timelines and risks, and considerations for data integration across platforms.
💾 𝘛𝘩𝘦 𝘯𝘦𝘹𝘵 𝘵𝘸𝘰 𝘷𝘪𝘥𝘦𝘰𝘴 𝘸𝘪𝘭𝘭 𝘢𝘭𝘴𝘰 𝘱𝘦𝘳𝘵𝘢𝘪𝘯 𝘵𝘰 𝘥𝘢𝘵𝘢 𝘮𝘢𝘯𝘢𝘨𝘦𝘮𝘦𝘯𝘵, 𝘴𝘰 𝘬𝘦𝘦𝘱 𝘢𝘯 𝘦𝘺𝘦 𝘰𝘶𝘵.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
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📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
Our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 series of interviews with RQM+ employees returns today as Christine Santagate, RAC is joined by enthusiastic Jordi Labs Technical Program Lead Joshua Nott. 👋
🎥 Hear how Josh's journey from biochemistry to analytical chemistry led him to excel in customer service and technical problem solving. Josh also shares:
✔️ His transition into project management
✔️ How he builds rapport with clients
✔️ His experience teaching and mentoring students
✔️ Valuable advice for those starting their careers
We think you can learn from Josh's expertise and passion for analytical chemistry and hope you enjoy!
🔬 We'll be highlighting more Jordi Labs staff in the coming weeks.
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📹 View and share this clip on LinkedIn.
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
Explore in vitro diagnostic (IVD) clinical trial site selection and monitoring with our latest videos in our educational video series on clinical trials.In these two videos (this is video 2) specific to site selection and monitoring, RQM+ experts reveal:
Key considerations for selecting ideal clinical partners Red flags to watch out for during site selection Best practices for effective trial monitoring Risk-based approaches to remote and on-site monitoring Strategies for data cleaning and accountabilityFeaturing insights from:
Margot Borgel - Director, IVD Global Regulatory Affairs Brandy Chittester - Senior Director, Clinical Operations Manali Patel - Clinical Research AssociateWhether you're a seasoned professional or new to IVD studies, this video series offers valuable tips to enhance your site selection process and streamline your clinical trials.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
Explore in vitro diagnostic (IVD) clinical trial site selection and monitoring with our latest videos in our educational video series on clinical trials.In these two videos (this is video 1) specific to site selection and monitoring, RQM+ experts reveal:
Key considerations for selecting ideal clinical partners Red flags to watch out for during site selection Best practices for effective trial monitoring Risk-based approaches to remote and on-site monitoring Strategies for data cleaning and accountabilityFeaturing insights from:
Margot Borgel - Director, IVD Global Regulatory Affairs Brandy Chittester - Senior Director, Clinical Operations Manali Patel - Clinical Research AssociateWhether you're a seasoned professional or new to IVD studies, this video series offers valuable tips to enhance your site selection process and streamline your clinical trials.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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This presentation and panel was recorded 8 August 2024. We encourage you to download Michelle Tarver's presentation slides by completing the form on this page. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can sign up for these events and more at the Knowledge Center at RQMplus.com.
Thank you for tuning in. 🙏
RQM+ welcomes Michelle Tarver, M.D., Ph.D., Acting CDRH Director and Deputy Center Director for Transformation, FDA, CDRH, to a presentation and panel discussion aimed at increasing awareness and understanding of equity in the medical device and IVD space.
Objectives:
Regulatory Expectations
Examining health equity concerns, regulatory efforts to promote equity, and FDA requirements for enhancing diversity in clinical trials
Healthcare at Home
Exploring the "Home as a Healthcare Hub" initiative and its implications for health equity, including the challenges and opportunities of integrating healthcare services at home
Industry Perspectives
Providing insights from industry leaders on how medical device companies are addressing health equity, with a focus on real-world examples and action plans
Action Plans and Strategies
Sharing best practices for developing and implementing plans that assess diversity, explore risks, and identify actions to address health equity within medical device companies
Interactive Q&A
Offering an opportunity for participants to engage with experts, ask questions, and gain a deeper understanding of the topicPanelists:
Michelle Tarver, M.D., Ph.D. – Acting Director and Deputy Center Director for Transformation, FDA, CDRH Allison Komiyama, Ph.D., RAC – Vice President, MedTech Innovations, RQM+ Jon Gimbel, Ph.D. – Vice President of Technical, RQM+ Brandy Chittester – Senior Director, Clinical Operations, RQM+ Jaishankar (Jai) Kutty, Ph.D. – Vice President, Global Regulatory Affairs, RQM+ (moderator)--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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Our ongoing educational video series on 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀 covers three areas:
♟️ Strategy
🛠️ Execution
✅ Regulatory
Optimize your IVD clinical trials and watch our newest video in the series: 𝗧𝗮𝗰𝘁𝗶𝗰𝗮𝗹 𝗖𝗼𝗻𝘀𝗶𝗱𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗜𝗩𝗗 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀.
Director of IVD Global Regulatory Affairs, Margot Borgel, Ph.D., is joined by Senior Director of Clinical Operations, Brandy Chittester, and Director of Business Development, Lauren Birch.
𝗪𝗮𝘁𝗰𝗵 𝗳𝗼𝗿 𝗲𝘅𝗽𝗲𝗿𝘁 𝗮𝗱𝘃𝗶𝗰𝗲 𝗼𝗻:
🔸 Outsourcing decisions and resource allocation
🔸 Critical pre-clinical testing considerations
🔸 Choosing the right clinical lab partner
🔸 Efficient execution strategies
🔸 Cost-saving tactics without compromising quality
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
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📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
🔄 We recently covered Site Selection In Clinical Trials and we're coming right back to share a new video on 𝗦𝗶𝘁𝗲 𝗠𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴.
For 𝗦𝗶𝘁𝗲 𝗠𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴 𝗜𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀, Jaishankar Kutty, Ph.D. is rejoined by Senior Director of Clinical Operations, Brandy Chittester, and also joined by Director of Clinical Operations, Martin Schulz.
𝗪𝗮𝘁𝗰𝗵 𝘁𝗼 𝗹𝗲𝗮𝗿𝗻 𝗮𝗯𝗼𝘂𝘁:
◽ Balancing on-site and remote monitoring based on risk assessment
◾ Location-specific considerations in site management
◽ Strategies for maintaining audit readiness throughout the trial
◾ RQM+'s approach to efficient and effective site monitoring
In addition to general best practices, watching this will give you a feel for how our collective experience and lean structures at RQM+ enhance trial oversight while ensuring patient safety, data accuracy, and regulatory compliance.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
🆕 Our newest video: 𝗦𝗶𝘁𝗲 𝗦𝗲𝗹𝗲𝗰𝘁𝗶𝗼𝗻 𝗜𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀.
Senior Director of Clinical Operations Brandy Chittester and Study Start-Up Associate Elicia Dellinger join Jaishankar Kutty, Ph.D. to explore the process.
𝗧𝗵𝗶𝘀 𝘃𝗶𝗱𝗲𝗼 𝗰𝗼𝘃𝗲𝗿𝘀:
Key factors influencing site selection The step-by-step process of identifying and assessing potential sites Balancing communication between sponsors, CROs, and trial sites Strategies to mitigate enrollment risksAnyone involved with clinical trial planning and execution will benefit from this one, with practical tips to enhance study success throughout.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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This was recorded 18 July 2024. We encourage you to download the presentation slides by completing the form on this page. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can sign up for these events and more at the Knowledge Center or Events pages at RQMplus.com.
Thank you for tuning in. 🙏
The recently finalized EPA rule on ethylene oxide (EtO) emissions requires significant changes for sterilization facilities, potentially impacting manufacturers of sterile medical devices.
Listen to our expert panel to understand the implications of these new regulations and discover actionable strategies to explore potential mitigation activities.
In this comprehensive discussion, our experts will cover:
Impact Assessment: A detailed analysis of the new EPA rule, including how it affects EtO sterilization facilities and manufacturers of sterile medical devices. Compliance Strategies: Guidance on softening EtO cycles to support the effort of reducing EtO emissions and ensuring compliance within the 2-3 year timeline. Alternative Sterilization Methods: An overview of viable alternatives such as Vaporized Hydrogen Peroxide (VHP), radiation, and more. We will discuss their pros and cons, regulatory requirements, and validation processes. Quality and Regulatory Support: Insights into design quality engineering, manufacturing quality engineering, regulatory change impact assessments, and more. Industry Perspectives: An examination of feedback from industry stakeholders and how companies are adapting to these changes.Who Should Listen: This panel discussion is ideal for regulatory affairs professionals, quality engineers, manufacturing leaders, and medical device manufacturers who rely on EtO sterilization or are considering alternative methods.
By listening in, you will gain a clear understanding of the new EtO regulations, learn practical steps to mitigate for compliance-led changes at your sterilization facilities, and explore alternative sterilization methods to ensure your products remain safe and market-ready.
Please complete the form to watch the recording and download the slides.
Panelists:
Jessica Dreyer – Senior Consultant, RQM+ Gregory Murdock – Senior Manager, RQM+ Jon Gimbel, Ph.D. – Vice President of Technical, RQM+ (moderator)--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
While she has moved towards retirement since recording this video with Jaishankar Kutty, Ph.D., Nancy Morrison, RAC talks about the regulatory landmines around 𝗰𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀 in the newest video in our clinical trials series.
𝗪𝗮𝘁𝗰𝗵 𝗳𝗼𝗿 𝗶𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗼𝗻:
◽ Determining the regulatory pathway for your combination product
◾ Addressing regulators' primary concerns in submissions
◽ Overcoming clinical trial challenges unique to combination products
◾ Key learnings from real-world cases
Whether developing drug-device combinations, drug-eluting implants, or other innovative combination products, this video offers guidance to help avoid costly delays and regulatory pitfalls.
If you're interested in RQM+ helping you strategically approach combination product development and set your product up for regulatory success, let us know. 📞
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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This conversation features a Q&A session with a CAPA-focused team from RQM+ and explores the unique value consultants bring to clients.
Our experienced team shares their top skills, dream projects, and what drives them to make a difference in the industry. From problem-solving strategies to personal inspirations, discover how these professionals are shaping the future of medical device quality and regulatory compliance.
Whether you're a professional simply interested in the field or a manufacturer interested in potentially leveraging consultant expertise, this conversation offers valuable perspectives.
Chapters
00:00 - Introduction to the Team
02:23 - The Difference Between Contractors and Consultants
05:13 - Leveraging Collective Knowledge for Client Success
07:36 - Top Skill Sets for Consulting Success
14:36 - Ideal Projects and Personal Goals
Panelists:
Elaine M. Ruminski, MS - Senior Consultant Craig McIntire - Senior Consultant Makenzie Dorring - Consultant, CMDA Joe Commane - Consultant Scott Edwards - Managing Director--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
Combination Device Clinical Trials: Strategy & Tactics
Join RQM+ experts Jaishankar Kutty, PhD and Chad Quistad as they unpack the complexities of combination device clinical trials in this comprehensive educational video.
Key topics covered:
Definition and examples of combination devices Regulatory pathways in the US and EU Product development challenges unique to combination products Essential documentation for robust trial design Critical considerations for successful trial executionHighlights include:
The importance of cross-functional expertise in drug and device development Crucial pre-trial steps: usability studies, risk analysis, and early stability testing Strategies for overcoming common trial execution challenges Real-world case study demonstrating the value of proactive testingWhether you're new to combination devices or looking to optimize your approach, this video offers valuable insights to enhance your clinical trial strategy.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
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📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
💡🏥 𝗨𝗻𝘃𝗲𝗶𝗹𝗶𝗻𝗴 𝘁𝗵𝗲 𝗦𝗲𝗰𝗿𝗲𝘁𝘀 𝗼𝗳 𝗦𝘂𝗰𝗰𝗲𝘀𝘀𝗳𝘂𝗹 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀
Part 2 of our key aspects of device trial design covers:
Overcoming key barriers in trial design Balancing statistical significance with clinical relevance Strategies for faster enrollment and reduced dropouts🎥 Cari Kniola, Guido Rieger, Rolf Hövelmann, and Jaishankar Kutty, Ph.D. share valuable insights to optimize your next clinical trial.
🔑 Key takeaway? 𝗘𝘅𝗽𝗲𝗿𝗶𝗲𝗻𝗰𝗲 𝗺𝗮𝘁𝘁𝗲𝗿𝘀. Learn how RQM+ leverages cross-functional expertise to design trials that deliver meaningful results.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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🤔 Struggling with patient recruitment for your medical device clinical studies?
Join RQM+ Clinical Trials COO David Novotny and THREAD CEO John Reites as they explore innovative hybrid study approaches to accelerate patient recruitment in MedTech research.
In this conversation, you'll learn how hybrid approaches can:
Expand your recruitment reach beyond geographical limitations Boost patient engagement and retention rates Save time and resources on data collection Ultimately accelerate your product's path to marketDavid and John dive into specific study designs ideal for hybrid approaches, including pre- and post-market clinical studies and randomized controlled trials. They emphasize the importance of patient feedback and human-centered design in creating flexible, patient-centric protocols.
Key topics covered:00:00 Introduction and Overview03:16 Types of Study Designs for Hybrid Approaches09:07 Examples of Hybrid Approaches in Med Tech Studies16:05 Impact of Hybrid Approaches on Patient Recruitment28:26 Strategies for Working with Older Populations in Hybrid Studies
Don't miss this opportunity to transform your research process and make your studies more efficient and patient-friendly.
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📹 View and share this clip on LinkedIn.
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
✏️ 𝗞𝗲𝘆 𝗔𝘀𝗽𝗲𝗰𝘁𝘀 𝗼𝗳 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹 𝗗𝗲𝘀𝗶𝗴𝗻 (𝟭/𝟮)
Cari Kniola, Guido Rieger, and Jaishankar Kutty, Ph.D. return for our educational clinical trial series, this time joined by Senior Manager of Biostatistics, Rolf Hövelmann.
This video covers...
𝗖𝗿𝘂𝗰𝗶𝗮𝗹 𝗧𝗿𝗶𝗮𝗹 𝗗𝗲𝘀𝗶𝗴𝗻 𝗙𝗮𝗰𝘁𝗼𝗿𝘀:
– Addressing and mitigating confounding factors, biases, and variations
– Ensuring treatment effects can be isolated
𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰 𝗔𝗽𝗽𝗿𝗼𝗮𝗰𝗵:
– The importance of considering end goals for product and study
– Incorporating clinical expertise from the start
𝗦𝘁𝗮𝘁𝗶𝘀𝘁𝗶𝗰𝗮𝗹 𝗔𝗽𝗽𝗿𝗼𝗮𝗰𝗵:
– Effective trial design from a biostatistics perspective
– Traditional vs. adaptive trial designs
𝗥𝗲𝗮𝗹-𝗪𝗼𝗿𝗹𝗱 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀:
– Balancing regulatory, reimbursement, and practical clinical needs
– Ensuring feasibility and practicality in trial execution
Look for the second video about trial design next week!
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 Follow RQM+ on LinkedIn.
💼 Check out our open positions.
📚 See on-demand content in our Knowledge Center.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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