*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 𝗧𝗿𝗶...
Aug 02, 2024•13 min•Transcript available on Metacast *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 Kutt...
Jul 31, 2024•13 min•Transcript available on Metacast 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...
Jul 18, 2024•48 min•Transcript available on Metacast *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 new...
Jul 17, 2024•15 min•Transcript available on Metacast 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 ma...
Jul 16, 2024•26 min•Transcript available on Metacast *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 educ...
Jul 11, 2024•19 min•Transcript available on Metacast *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 ...
Jul 08, 2024•13 min•Transcript available on Metacast 🤔 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...
Jul 05, 2024•31 min•Transcript available on Metacast *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...
Jul 01, 2024•13 min•Transcript available on Metacast *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.* 🛡️ 𝗥𝗶𝘀𝗸 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗜𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀 Senior Director of Clinical Operations Brandy Chittester and Senior Diretor of Project Management Cari Kniola join Jaishankar Kutty, Ph.D. to discuss...
Jun 27, 2024•14 min•Transcript available on Metacast *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.* 💰 𝗪𝗼𝘂𝗹𝗱 𝘆𝗼𝘂 𝗹𝗶𝗸𝗲 𝘁𝗼 𝗴𝗲𝘁 𝗿𝗲𝗶𝗺𝗯𝘂𝗿𝘀𝗲𝗱? Securing regulatory approval is just the beginning. The newest video in our educational clinical trials series covers the intricacies of reimbursement strat...
Jun 25, 2024•14 min•Transcript available on Metacast *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 educational video series on clinical trials continues today with 𝗧𝗮𝗰𝘁𝗶𝗰𝘀 𝗳𝗼𝗿 𝗚𝗹𝗼𝗯𝗮𝗹 𝗣𝗶𝘃𝗼𝘁𝗮𝗹 𝗦𝘁𝘂𝗱𝗶𝗲𝘀. Senior Project Manager Guido Rieger joins VP of Global Regulatory Affairs, Jaishanka...
Jun 20, 2024•22 min•Transcript available on Metacast *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.* 🔍 Strategy for Global Pivotal Studies 🌍 Ever wondered what it takes to ensure the success of your clinical trials on a global scale? Our latest video in the 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗖𝗥𝗢: 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗦...
Jun 18, 2024•17 min•Transcript available on Metacast *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.* ❓ How do you effectively 𝗲𝘅𝗲𝗰𝘂𝘁𝗲 first-in-human clinical studies? ❓ What 𝘁𝗮𝗰𝘁𝗶𝗰𝗮𝗹 𝘀𝘁𝗲𝗽𝘀 ensure success?After our first two strategic videos, our educational video series on clinical trials continues with ...
Jun 12, 2024•12 min•Transcript available on Metacast *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.* ❓ What are the CGMP principles and traceability requirements for 𝗳𝗶𝗿𝘀𝘁-𝗶𝗻-𝗵𝘂𝗺𝗮𝗻 𝘀𝘁𝘂𝗱𝗶𝗲𝘀? How do you manage device iterations and site selection effectively? 🎬 The second video in our 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗖𝗥𝗢: ...
Jun 10, 2024•13 min•Transcript available on Metacast This was recorded 6 June 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. 🙏 Summary Th...
Jun 07, 2024•1 hr 10 min•Transcript available on Metacast *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.* ❓ What are the objectives and benefits of conducting 𝗳𝗶𝗿𝘀𝘁-𝗶𝗻-𝗵𝘂𝗺𝗮𝗻 𝘀𝘁𝘂𝗱𝗶𝗲𝘀? What are the key considerations and best practices for manufacturers? We have answers. 🏥 Here's the first video in our 𝗠𝗲𝗱𝗧𝗲...
Jun 05, 2024•11 min•Transcript available on Metacast 🎓 𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝗶𝗻𝗴 𝗼𝘂𝗿 𝗻𝗲𝘄 𝗲𝗱𝘂𝗰𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝘃𝗶𝗱𝗲𝗼 𝘀𝗲𝗿𝗶𝗲𝘀 𝗼𝗻 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀. Our VP of Global Regulatory Affairs, Jaishankar Kutty, Ph.D. , welcomes you to a free series designed to share our wealth of knowledge and best practices in clinical trial strategy, execution, and regulatory expertise. 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀 𝗼𝗳 𝘁𝗵𝗶𝘀 𝘀𝗲𝗿𝗶𝗲𝘀: ✨ In-depth insights from industry experts 🛠️ Practical tips and best practices 📄 Comprehensive and interact...
Jun 03, 2024•2 min•Transcript available on Metacast 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. "Encouraging and driving a strong culture of quality allows a company to effectively manage the details in a collaborative way." Scott Edwards , Managing Director at RQM+, shares his extensive industry experience and personal journey in our latest 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰...
May 08, 2024•14 min•Transcript available on Metacast This show was recorded 25 April 2024. We encourage you to download the IVDR timeline presented at the beginning of this session by completing the form on this page . Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the Knowledge Center or Events pages at RQMplus.com. Thank you for tuning in. 🙏 Summary In this conversation, panelists discuss the crucial role of Notified Bodies in the EU...
May 01, 2024•57 min•Transcript available on Metacast 𝗡𝗘𝗪𝗦 → FDA releases final rule on Laboratory-Developed Tests (LDTs) 🚨 RQM+'s Bethany Knorr Chung, PhD, RAC and Margot Borgel, Ph.D. dive into the details of what you need to know, including: ✅ The 4-year phase-in timeline for compliance ✅ Expanded enforcement discretion for certain LDTs ✅ Grandfathering clause for currently marketed LDTs Watch now to learn how this rule impacts your business and what steps you need to take to ensure compliance. - 📹 View and share this clip on...
Apr 30, 2024•12 min•Transcript available on Metacast 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. 🔬 Hot on the heels of Jordi Labs ' groundbreaking new publication support for simulated use testing of blood-contacting medical devices, we're thrilled to showcase one of Jordi's shining stars in our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 series: Meet Samantha H...
Apr 29, 2024•12 min•Transcript available on Metacast In this special bonus clip from our Excellence Spotlight series, Sr. Director of Data Operations (Clinical Trials) Noel Keegan takes a deep dive into clinical data management. From the transition to electronic systems to the exciting potential of AI, Noel reflects on the evolution he's witnessed over his 16+ year career. He breaks down the key aspects of data management across the study lifecycle: 🏁 Study Start-Up : Collaborating with cross-functional teams to build user-friendly, robust da...
Apr 19, 2024•11 min•Transcript available on Metacast While we believe you will find Nancy's story and advice inspiring without visuals, we encourage you to watch the video version containing a brief presentation on the RQM+ website here . In this heartfelt and insightful video presentation, now available on our blog, Nancy Morrison, RAC shares her journey and the lessons she's learned along the way. Nancy is as highly a respected professional as you'll 𝘦𝘷𝘦𝘳 find in regulatory affairs and as she embarks on her well-deserved retireme...
Apr 12, 2024•20 min•Transcript available on Metacast This show was recorded 28 March 2024. We encourage you to download the presentation given in the first portion of this session by completing the form on this page . Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the Knowledge Center or Events pages at RQMplus.com. Thank you for tuning in. 🙏 Summary The conversation in this part focuses on the importance of quality systems and compliance in...
Apr 10, 2024•55 min•Transcript available on Metacast Our Excellence Spotlight interview series celebrates and showcases the remarkable journeys and achievements of RQM+ employees. These employees are committed to technical excellence and make significant positive contributions to our clients' success. In our newest interview, we're thrilled to showcase Vice President of Strategic Regulatory Affairs, Dr. Sew-Wah Tay . It was tough to share just a single quote from this interview! Jaishankar Kutty, Ph.D. definitely helped bring out the best ...
Apr 04, 2024•15 min•Transcript available on Metacast RQM+ Vice President of Global Regulatory Affairs (and former BSI), Jaishankar Kutty, Ph.D. , discusses the process of reviewing clinical evaluation reports (CERs) by notified body reviewers under the EU MDR in our newest video clip. In the end and more than anything, manufacturers must provide a clear and comprehensive story in their CERs to facilitate the review process. 📖 Highlights: Notified body reviewers play a crucial role in the review process of clinical evaluation reports (CERs) under ...
Apr 01, 2024•13 min•Transcript available on Metacast 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. 🧪 With a fascinating career spanning drug development with GSK to addressing ESPN's water issues, RQM+ / Jordi Labs Senior Study Director Adam Eason 's journey has shown his willingness to embrace the unknown and leverage seemingly every experience when solving compl...
Mar 26, 2024•11 min•Transcript available on Metacast 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 newest Excellence Spotlight interview is with Noel Keegan , a central figure in RQM+ clinical trial services. Noel is Sr. Director of Data Operations and has expertise that bridges gaps between data management, clinical operations, and regulatory compliance. His forward-t...
Mar 21, 2024•11 min•Transcript available on Metacast 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. 🔬 Kaitlin Lerner is "that chemist" with a Gibbs free energy tattoo. As Director of Operations, she's also one of the most brilliant minds on the RQM+ Lab Services / Jordi Labs team. In this week's Excellence Spotlight interview, she shares her fascinating j...
Mar 13, 2024•11 min•Transcript available on Metacast 
