R&D Today’s Post

Dive into the history and purpose of RBQM, gain essential insights and strategies for implementation, and explore proven best practices for complex applications. This guide is your comprehensive resource for transforming clinical research with RBQM. Check it out: https://hubs.ly/Q02L0Gsb0 #RBQM #ClinicalTrials #ClinicalResearch

Reflections from SOCRA Annual Conference: The Future of Clinical Research I recently had the privilege of attending the SOCRA annual conference, where I engaged with clinical managers from prestigious research institutions and industry. The insights gained were invaluable, and I wanted to share some key takeaways: 1. Centralized Monitoring: Emerging as a game-changer in improving trial efficiency and data quality. 2. Risk-Based Quality Management (RBQM): No longer just a buzzword, but a critical approach being adopted by leading institutions to enhance risk management and trial oversight. 3. Quality Assurance: Remains at the forefront, with innovative strategies being developed to maintain the highest standards in research. 4. CRA and Research Coordinator Challenges: Frank discussions revealed common pain points and creative solutions being implemented across institutions. What struck me most was the collaborative spirit among these top-tier research centers. Despite coming from different organizations, there was a shared commitment to advancing clinical research practices for the benefit of patients worldwide. Key questions that emerged: • How can we better integrate RBQM into existing workflows? • What technologies are most effective for centralized monitoring? • How can we support our CRAs and research coordinators in adapting to these new methodologies? I'm excited to see how these conversations will shape the future of clinical research. What are your thoughts on these trends? How is your organization tackling these challenges? #ClinicalResearch #SOCRA #RBQM #CentralizedMonitoring #ResearchExcellence #TCSADD #SOCRA2024

Building Partnerships for Better Research Strong partnerships are at the heart of successful clinical research. MERCLINCO collaborates with global leaders to advance healthcare innovation. Discover how MERCLINCO’s partnerships contribute to groundbreaking research. #PartnershipsInResearch #MERCLINCO #HealthcareInnovation #ClinicalExcellence Merclinco Institute of Training

𝗛𝗼𝘄 𝘁𝗼 𝗮𝗰𝗵𝗶𝗲𝘃𝗲 𝗰𝗼𝗺𝗺𝗲𝗿𝗰𝗶𝗮𝗹 𝘃𝗶𝗮𝗯𝗶𝗹𝗶𝘁𝘆 𝗳𝗼𝗿 𝘁𝗵𝗲 𝗨.𝗦. 𝗵𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲 𝗺𝗮𝗿𝗸𝗲𝘁 LIOF, Brightlands Maastricht Health Campus and RQR Advisors LLC are organizing an exclusive two-day workshop to prepare medical companies for the U.S. market. The U.S. market is attractive to European manufacturers of medical products due to its extensive healthcare expenditure and strong demand for advanced products and technologies. Due to the challenges on the European MDR-regulations, more and more medical companies consider going to the U.S. market parallel to or even before the EU market.

It was a privilege to co-organize the EAA Spring Convention, themed 'Finding the Right Balance,' at Erasmus Universiteit Rotterdam alongside Maureen Rutten-van Mölken, Joerg Ruof, and Elaine Julian. Navigating the EU's market access for medicines and devices involves balancing uncertainty and managing the trade-off between potential risks and benefits, including type 1 and type 2 errors. The aim of Health Technology Assessment (HTA) regulation is to expedite access to new drugs with added value, harmonizing processes, and reducing redundancy. The pivotal question remains: Does Joint Clinical Assessment (JCA) truly accelerate access? JCA may offer a promising solution for enhancing access to new cancer drugs in the EU through mechanisms like consolidating resources and expertise, streamlining evaluations, and promoting harmonization of evaluation criteria and standards. Furthermore, JCA may have the potential to ensure comprehensive evaluation by engaging diverse stakeholders, but discussions revealed challenges in achieving this balance, with stakeholders expressing doubts about its feasibility. Key discussion points included balancing stakeholder involvement in EU HTA regulation, effectively managing uncertainty, understanding the risk-benefit balance in regulatory decisions, defining evidence for new treatments, and navigating the delicate trade-off between undertreatment and overtreatment. These discussions underscored the critical importance of collaborative approaches, evidence-based decision-making, and ensuring equitable access to innovative therapies for improving healthcare outcomes across the EU. At the EAA, we also presented the ASCERTAIN project, focusing on developing a policy support tool encompassing new pricing models, a comprehensive HTA framework, and innovative reimbursement and payment schemes. Attendees showed keen interest in the use cases, evidence, and decision support tool. #access #drugs #reimbursment #HTA #regulation

We are excited to announce that STAC | Scale is expanding its mentorship and support offerings for our upcoming Cohort 5, launching in December. Through a new partnership with the University of Glasgow's Digital Health Validation Lab (DHVL), health tech companies joining our programme will now benefit from specialised, industry-specific guidance to help accelerate their innovations. This partnership introduces an additional mentorship pillar to the programme, providing domain-specific insights to help founders in the digital health sector succeed. DHVL brings invaluable resources, including access to clinical experts, patients, and clinical trials, which we'll match with a structured programme to guide and support core healthcare and regulatory foundations as well as best business practices. For founders, this partnership will streamline the journey from concept to commercialisation. Establishing a clear go-to-market strategy—covering consultation, evidence generation, regulatory approval, and beyond—is essential for growth, and we are thrilled to partner with DHVL’s impressive team to offer enhanced support for founders aiming to make a positive impact in healthcare. Applications are now open for #STAC5 https://lnkd.in/eHpqKkdZ

eTMF systems are a real game-changer for clinical research – but did you know that the key to unlocking their full potential is only available after going live? In the article, we explain why your strategy post-launch defines future success and discusses the importance of continuous improvement and stakeholder engagement in post-eTMF implementation. Read more in the blog article with MICHAEL AGARD, Director of Clinical Consulting, NNIT >>> https://okt.to/lApJjT

Why does lab accreditation matter? Laboratory accreditation can be a laborious process, especially if you're seeking accreditation from multiple bodies or from those outside of your country. However, it's one of the most powerful things you can do for your organisation. Accreditation provides an extra layer of confidence in your lab's abilities and demonstrates a commitment to excellence. It shows that you're dedicated to going above and beyond what's required of you, which can help you stand out in oversaturated markets. At MedLabs, we have over 30 years of experience, which we use to support labs in the MENA region throughout their accreditation journeys. Discover how we can help you here: https://lnkd.in/eSrQ4B-T #LabAccreditation #Accreditation #Healthcare #Consulting

Consider taking the path less traveled 🗺️ with insight at our upcoming webinar presented by Isaiah Manoogian, PharmD. This presentation will cover expedited #FDA review programs to help you determine if there's a streamlined way for your innovation to serve unmet needs. 🧪https://ow.ly/MzT850TZFh7

Spotlight on Day 2 at Lab Institute 2024! Today’s agenda is packed with insights that redefine diagnostic medicine’s role and impact. From innovations in lab leadership to the latest compliance strategies, this is the place where change-makers converge to shape the future of healthcare. Today's Agenda: ⏰ 11 AM - 12 PM ET: "Washington Update: What Labs Should Know" with Joyce Gresko. ⏰ 12:30 PM - 1:30 PM ET: "Revenue Integrity: Understanding NCCI Policy and Application of the Rules" with Robin Zweifel. ⏰ 2:00 PM - 3:00 PM ET: "Lab Enforcement: Current Trends and Compliance Tips for Labs" with Danielle Sloane and John Eason. ⏰ 3:30 PM - 4:00 PM ET: "Panel Discussion: What’s Going on with LDTs Regulation?" with Shannon Bennett and Sheila D. Walcoff, JD. Click here to register: https://bit.ly/3ZCQFne #LabEnforcement #DiagnosticInnovation #AdvancingMedicine