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 databases with carefully considered edit checks. ?‍♂️ Ongoing Maintenance: Proactively cleaning ..read more

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 preventing negative impacts on customers, patients, and reputation. The panelists discuss the history and ..read more

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 in Sew-Wah. With a rich background in science and engineering, Sew-Wah's had an incredible c ..read more

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 the MDR. Manufacturers should appreciate the challenges faced by notified bodies and provid ..read more

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 complex scientific problems. ? His diverse experience includes drug development, environmental ..read more

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-thinking approach has elevated our clinical trial methodologies and consistently ensured the succ ..read more

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 journey with Lab Services Chief of Staff, Christine Santagate, RAC (welcome to the Excelle ..read more

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. Yesterday, we published a clip of RQM+ Senior Consultant Anastassia Young, MS discussing our recent conversation with the FDA related to Adverse Event (AE) Reporting. Today, it's time to shine the spotlight on her and only her in our newest Excellence Spotlight. ? A quick glance at what Anastassia brings to RQM+ and our clients: ? Technical Savvy and Sto ..read more

Are you navigating adverse event (AE) reporting in post-market clinical follow-up (PMCF) studies? In a recent discussion with the FDA, we've uncovered valuable insights into exemptions and variances for AE reporting that could significantly reduce your reporting burden. This collaboration between RQM+ and the FDA paves the way for a more efficient process, allowing for the submission of a single summary report for AE data collected in PMCF studies. ? You'll want to watch for... Valuable FDA Insights: Learn about exemptions and variants for AE reporting. Efficient Data Collection:&nbs ..read more

This show was recorded 22 February 2024. We encourage you to download the supplemental PDF content for 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 panelists discuss the requirements for claiming equivalence under the MDR and provide examples of devices that are impacted. They also address actionable steps and next steps for manufacturers. The discussion cove ..read more