Menken Trials’ Post

Some great topics coming up folks. Follow us so you can be alerted when information becomes available. June - Learn how to drop that mic July - Two days packed with medical device quality system content August - Getting things done without formal authority September - A risk-based approach to software validation October - Fostering a quality culture and a risk-based approach to CAPA

Some great topics coming up folks. Follow us so you can be alerted when information becomes available. June - Learn how to drop that mic July - Two days packed with medical device quality system content August - Getting things done without formal authority September - A risk-based approach to software validation October - Fostering a quality culture and a risk-based approach to CAPA

Phlexglobal's #TMF Quality Review (also known as a "file review") offers an in-depth, line-by-line assessment of your Trial Master File (TMF), ensuring that you have a clear understanding of its quality, comprehensiveness, and punctuality. Don't miss out on this opportunity to gain valuable insights into your TMF's performance and compliance with Good Clinical Practice (GCP) standards and regulatory requirements for essential documents. Discover more about our TMF Quality Review service here:🔗 https://lnkd.in/g6WHism2 Remember, quality is one of the three key metrics of TMF Health. Make sure your TMF is up to par and compliant with industry standards by taking advantage of Phlexglobal's expertise. #TMFQualityReview #GCPCompliance

✅ How to compile your technical documentation with success for regulatory submission ? In this practical guide, find advice for compiling your technical documentation for a regulatory submission to your notified body. A quick guide to read that will help you better approach this key stage in the life of your medical device. The PDF should be opened with your default internet browser in order to correctly display the fonts in the guide. Guide here : https://lnkd.in/eCgicJRK

Learn the critical role of Electronic Delegation of Authority (DOA) in clinical trials, including tips for successful adoption, transitioning DOA in existing studies, and common pitfalls to avoid. Whether you're a seasoned professional or new to the field, this webinar will offer valuable strategies to ensure your audit readiness success. Register here ⇢ https://bit.ly/49UOq0i

🔍 Elevate your clinical trial game with DocQc's innovative monitoring solutions! 🚀 Real-time insights, proactive management, and optimized results - all in one place. Let's collaborate to take your trial to the next level! 💡 #ClinicalTrials #InnovativeSolutions #TrialEfficiency

Building a strong TMF that is reliable, credible, and inspection-ready at all times is crucial for the reconstruction of any clinical trial. Successful TMF trial management can be facilitated by: 1) Standardizing Processes: Implementing SOP’s for filing or QCing a TMF document ensures your team is consistently delivering the same quality of work. Read more here: https://bit.ly/4e1wnbE * * * #TrialMasterFile #eTMF #ClinicalResearch

Learn more about common findings regarding electronic systems during inspections!

Common findings during inspections! This video is about electronic systems and common findings related to electronic systems used in a clinical trial. LINK Medical `s discussion corner is continuing with a new topic next week. Gunnar Danielsson , senior consultant & former GCP inspector and Rikard Reneland Medical Director : Common findings with electronic systems in a clinical study, a very relevant topic for us working with clinical trials. Listen below. The link is also in the comment field https://lnkd.in/dWbkn66Q

Do you know the role regulatory engagement can play in your clinical trial's success? Find out in my team member's blog today: https://bit.ly/3VsgbYQ