TRI - The RBQM Experts’ Post

🎉🎉We're so excited to launch this virtual event.🎉🎉📅 Join Kirsten McAulay and Macarena Sahores as they combine 5, concise and informative episodes into one afternoon (or morning, depending where you're joining us from!) walking you through the complete protocol risk assessment process, as laid out in ICH E6. "Mastering Clinical Trial Management", is a complimentary virtual event designed for professionals looking to advance their expertise in clinical trial risk management, at an intermediate level. Sponsors and CROs Only https://lnkd.in/es6WgKrt #RBQM #ICHE6 #ICHE8 #riskmanagement #trialmanagement #virtualevent #protocolriskassessment #regulatoryguidance

What is the level of RBQM adoption in clinical trials and what insights does that give us? Join the ACDM Hot Topic with Marcel van Willigen on 28th June. #JuliusClinical #ACDM #RBQM #clinicaltrials #clinicaldatamanagement

Happy Friday! Let me tell you about simplifying RBQM with TRI's OPRA Platform. Managing clinical trial risk shouldn’t be complicated. That’s where OPRA comes in. Built to support smarter, data-driven decisions, OPRA helps CROs and sponsors streamline trial oversight and improve efficiency. Here’s how it works: 🔹 Proactive Risk Management – Spot and address issues early to keep studies on track. 🔹 Central Monitoring – Gain real-time oversight and reduce the need for costly on-site visits. 🔹 Regulatory Compliance – Stay audit-ready with transparent, traceable data. 🔹 Custom-Fit Solutions – Every trial is different, so we tailor our approach to fit your specific needs. At TRI, we’re helping organisations take control of trial quality and efficiency. If you’re looking to do the same, let’s have a chat about how OPRA can support your next study. #RBQM #ClinicalTrials #DataDriven #CentralMonitoring #Efficiency #Compliance 💡 Curious to learn more? Drop me a message! Steve Matheson E: Lamek.Ogwal@tritrials.com T: +442045825463 M: +447999485788 #RBQM #ClinicalTrials #RiskManagement #RiskAssessment #PatientSafety #DataQuality #CRO #OPRA #TRI

Having seen a sneak preview of the results in the RBQM DMEG I am very much looking forward to discussing the final outcomes (very kindly analysed by Rich, Adam and Marcel). I'm particularly interested in what other Academic unit's experiences of RBQM adoption have been like. Should be a very interesting discussion! #academicclincaltrials #rbqm #acdm

LAST SEATS - Webinar Alert! 🔊 Are you involved in #ClinicalTrials ? If so, don’t miss out on our upcoming webinar: “Getting the Right Level of Sponsor Oversight”! 🗓️ Date: May 13 & 15, 2024 🕒 Time: 2 webinar sessions of 3 hours each In this highly interactive course, we’ll guide you through the critical aspects of #sponsor oversight, ensuring patient safety and data integrity. This session will provide you with practical solutions for applying ICH E6 (R2) #GCP & EU Clinical Trial Regulation (#CTR) 536/2014. 🔍 Key Topics: • Ensuring human subject protection • High-quality data • Oversight of trial-related duties • Staff qualification • Risk management activities 👉 Register now to secure your spot: https://lnkd.in/ece42RiW 📧 Contact us at info@eccrt.com #ECCRT #SponsorOversiight #Learning #ClinicalResearch

Looking ahead, Cyntegrity is advancing its RBQM platform with AI-enhanced data intelligence to simplify study protocols, enhance risk management, and uncover opportunities across clinical trials and portfolios. By positioning RBQM as a functional component within a broader data-driven clinical trial ecosystem, Cyntegrity helps sponsors streamline processes, explore new opportunities, and make confident, informed decisions. Explore how Quality by Design comes to life with MyRBQM® Portal: https://lnkd.in/duJiAbj3

Michael Agard to Speak at the 2024 CDISC Conference! 🎉 We are thrilled to announce that Michael Agard, Principal Consultant at Epista Life Science, will speak at the 2024 US CDISC + TMF US Interchange in Phoenix/Scottsdale on October 23. Michael will share his deep knowledge of “Applying Quality by Design (QbD) to TMF Risk Management.” ✨ In his session, Michael will delve into: 💡 Consistency and Standardization: - How to ensure TMF uniformity across studies, countries, and sites. 💡 Modular Design: - Tracking the TMF documents to be collected at milestones to maintain a cohesive clinical trial narrative. 💡 Risk Management: - Proactive risk management, including regular reviews and oversight, to ensure safety and compliance. 💡 Customer Focus: - How a well-managed, inspection-ready TMF meets the needs of stakeholders—from patients to auditors. If you’re attending the conference, don’t miss out on Michael’s insights about creating a complete TMF that tells the full story of a clinical trial! 🚀 #ClinicalTrials #TMFManagement #QualityByDesign #RiskManagement #CDISC #LifeSciences

Heads up for continued insight from TRI - The RBQM Experts this time centred on the use of Key Risk Indicators (KRI's) and their importance in the effective management of sites in #clinicaltrials. Safety, Quality, Compliance - finetune your focus.... #RBQM #centralizedmonitoring #regulatorycompliance #efficiency

Defining your monitoring strategy…… Thank you to Rachel Oakley of Regeneron for leading the session “Defining your monitoring strategy from your risk assessment” at the 2nd Annual ACDM: Association for Clinical Data Management Symposium on Risk-Based Quality Management. In this session, Rachel took the audience through the process of creating a fit-for-purpose monitoring strategy proportionate to the risks of the study, taking into account what has been identified as critical in the risk assessment. This presentation provided a detailed approach to selecting the right cross-functional monitoring strategy for a study. #clinicalresearch #clinicaltrials #clinicaldatamanagement #clinicaloperations #edc #ACDM #RBQM #clinicalresearch #clinicaltrials #clinicaldatamanagement #clinicaloperations #edc #ACDM #RBQM

Welcome to day 2 of the RBQM Symposium…… Following a fantastic networking evening, day 2 of the 2nd Annual ACDM: Association for Clinical Data Management Symposium on Risk-Based Quality Management kicked off with Jess Gomes of Roche delivering the session "A RBQM Journey to Data Reliability." This session looked at the challenges of shifting from a focus on 100% data accuracy to data reliability within the context of risk-based quality management. It explored how to operationalise risk proportionality across various functions, building trust in regulatory expectations, and navigating cultural differences in global organisations. #clinicalresearch #clinicaltrials #clinicaldatamanagement #clinicaloperations #edc #ACDM #RBQM