InSilicoTrials’ Post

The Developing Child and Orphan Devices (DeCODe) project has launched a call for applicants to support paediatric and orphan device developers The selected developers will benefit from innovating coaching and support The applicaiton link and further information is below #EU4health #raredisease #medicaldevice #MedTech

The #DeCODe project has launched a call for support for paediatric and orphan device developers. Successful applicants will benefit from the support of two dedicated innovation coaches to help achieve their development goals. Support will be available to a wide range of developers, including but not limited to academics and individual researchers, startups and industrial players, organizations from diverse settings, and patient-led developers, for both new device development and the adaptation of existing products for the orphan and paediatric populations. Assistance will be provided at various stages of the product lifecycle to ensure the success of these vital innovations. The type of support that qualify are, amongst others, business advice, funding advice, network building, technical advice, regulatory guidance, infrastructure for (pre-)clinical testing and/or a needs assessment. More information and applications: https://lnkd.in/eYJj_WJG Tom Melvin, Ali McDonnell, Isabelle Huys, Fenna Mahler, Ricardo Fernandes, Hayley Every, Akvile Zalatoryte, MSc, VBHC Green Belt, Jen Tidman, Vincenzo Carbone, PhD, Dr Donal O'Connor, Virginie HIVERT, Kolaleh Eskandanian, Maurizio Scarpa, Annalisa Sechi, Mark Turner, Marco Raaben #EUfunded #HealthUnion #EU4Health #HealthierTogether, #CallOpen, #Orphandevices, #rarediseases 

👥 Breaking Myths: Chile's Diverse Patient Pool in Clinical Trials 📊 Many believe that clinical trials are best conducted in countries with large populations. However, Chile shows us a different perspective. With its diverse patient pool, Chile offers a unique advantage for medical device trials. This diversity enhances the reliability of trial results, making them applicable to a wider range of populations globally. Contrary to traditional views, Chile's 20 million population, rich in ethnic and demographic variety, provides a robust foundation for inclusive research. By embracing this diversity, medtech companies can achieve more representative and generalized outcomes, paving the way for global healthcare advancements. Chile is not just a participant in the clinical trial world; it's a growing leader. 🌍 #Medtech #ClinicalTrials

Brazil is emerging as a prime location for medical device clinical trials, thanks to its advanced healthcare infrastructure. With over 3,000 research centers, including top-tier hospitals and clinics, the country offers a robust foundation for innovative studies. 🏥 Brazil's Unified Health System (SUS) plays a pivotal role, providing an extensive network for efficient patient recruitment and trial execution. This integration ensures that research outcomes can seamlessly influence public health policies. 📊 For medical device startups aiming to conduct early feasibility trials, bioaccess® stands out as the only Medtech CRO in Latin America, ready to operationalize these studies in Brazil. Discover how Brazil's infrastructure can accelerate your clinical trial success. 🚀 #Medtech #ClinicalTrials

Community-based research sites are revolutionizing clinical trials by making them more accessible, increasing recruitment and retention rates, and promoting diversity. Although there are misconceptions about regulatory oversight, trial complexity, and costs, these sites maintain high standards, offer exceptional care, and ultimately save money in the long run. EmVenio Research is at the forefront of this movement, showcasing how community involvement and mobile research sites can significantly boost trial effectiveness and inclusivity. Discover more in the full article: https://hubs.ly/Q02W9RRz0 #communityresearch #clinicalresearch #EmVenioImpact

More than 50% of EmVenio’s trial participants come from minority populations compared to the industry average of 20%. Additionally, the retention rate for EmVenio trial participants is 92% – significantly higher than the industry average of 70%. These statistics highlight how community-based research sites can remove obstacles to participation and ensure a trial recruits people from across the spectrum of human experience. #Reach #PatientJourney #Trust

Innovation in Rare Disease Research: The DeCODe Project Kick-Off!   We're excited to announce that Conect4Children Stichting is part of the DeCODe initiative—a groundbreaking two-year project supported by the European Union. DeCODe aims to transform the future of healthcare for people living with rare diseases (PLWRD), particularly children. With such a substantial unmet need for paediatric and orphan medical devices, DeCODe is here to change the landscape.   This initiative brings together clinicians, researchers, industry experts, and regulatory authorities to build a comprehensive platform to support the development of safe and effective paediatric and orphan medical devices. Through collaboration, DeCODe will identify key stakeholders, map out critical innovation pathways, and offer developers tangible support.   By March 2025, five selected developers will receive grants and tailored guidance to drive their medical device innovations forward. The goal? To see 3-5 new devices approved and integrated into rare disease care—bringing real solutions to patients and healthcare professionals alike.   This project, financed by the European Union's EU4Health programme, will be coordinated by the University of Twente in collaboration with global partners like the US Alliance for Pediatric Device Innovation. We are thrilled to be a part of this important mission and can't wait to see the life-changing developments ahead!   Find out more on the DeCODe website soon! #EU4Health, #UT, #rarediseases, #Medicaldevices

📢 Unveiled today at The MedTech Conference in downtown Toronto, the Ontario Government | Gouvernement de l’Ontario has announced the next phase of Ontario’s life sciences strategy, committing an additional $146 million in support of tools and programs that will help establish Ontario as a global biomanufacturing and #lifesciences hub. This investment includes $5 million for Clinical Trials Ontario and the innovative #QuickSTART program, which reduces barriers and helps speed up #clinicaltrial start-up times. Clinical Trials Ontario thanks the Government of Ontario for its continued support in fueling a thriving clinical trials sector that will bring more talent and trial opportunities to the province, advance healthcare for patients and drive innovation in medicine.  Read more: https://bit.ly/3Y4Y8sN #LifeScienceStrategy #ONecon #MedTechCon #medtech #MTC24 Life Sciences Ontario, Susan Marlin, Doug Ford, Victor Fedeli, Nina Tangri, Sylvia Jones

🤝 We’re a PACT-project partner, helping to make clinical trials more accessible to patients in Denmark!   ⛔️ Clinical trials traditionally take place within hospital departments, creating a barrier to access for many patients. By leaning into today’s technology, life science companies and healthcare organisations can reduce or eliminate the need for participating patients to make physical visits to a research site.    ✅ The PACT project is a public-private partnership that aims to find ways to improve patients’ accessibility to clinical trials. With the right combination of electronic informed consent and state-of-the-art tools like video consultations, digital monitoring, apps, wearables and local outpatient clinics, patients can participate in trials close to home.    Denmark consistently ranks at the top of the EU Digital Economy and Society Index (DEAI) report, and we’re also ranked near the top for clinical trials per capita. The PACT project builds on this strong foundation, paving the way for Denmark to become a global frontrunner in decentralised clinical trails (DCT).   The PACT project is funded by Innovation Fund Denmark and supported by representatives from these organisations within Denmark: Trial Nation, Region Hovedstaden, Region Sjælland, Region Syddanmark, Region Midtjylland, Region Nordjylland, IQVIA Nordics, Merck A/S, Novartis Danmark, Novo Nordisk, Oticon, Roche Danmark, @World Courier – Specialty Logistics Specialist, and Aalborg University.    🇩🇰 Read more about this project on trialnation.dk – or download the new one-pager for a quick overview of Denmark’s capabilities and strategic focus related to DCTs. 👉 https://lnkd.in/dupj7-cy

🌟 Real World Evidence Panel Insights at the #2024CTIPSymposium🌟 We're thrilled to highlight the insights shared by our speakers during the RWE Panel at the 2024 Pediatric Device Innovation Symposium. -Katie Mues, PhD, MPH, Vice President, Science, Aetion, on data organization: "There is no perfect database, but understanding the potential databases deeply before executing a real-world study is crucial. Building a collaborative ecosystem that fosters meaningful conversations is key, and that's something we’re constantly prioritizing in this space." -Stacey Ellul, RN, MBA,Vice President, Quality & Regulatory, NeuroPace highlighted how the pediatric benefit-risk balance differs significantly from that of adults, and why we should center discussions around pediatric needs. -Cori Maegley, Vice President, Partnerships Management, National Evaluation System for health Technology Coordinating Center (NESTcc)) on the potential for RWE: "Medical device companies want to reduce uncertainty. If we can demonstrate that real-world evidence is no riskier than traditional clinical studies, we can encourage broader adoption across the entire ecosystem and leverage it to improve patient access to critical device innovations.” -Charles Viviano, MD, PhD, Chief Medical Officer, Office of Clinical Analysis and Evaluation, Center for Devices and Radiological Health, FDA emphasized that the FDA holds real-world evidence to the same standards as traditional evidence, applying identical benefit-risk assessments and ensuring reasonable assurances of safety and effectiveness. Thank you to our speakers for sharing their knowledge and passion! Did you attend the 2024 Pediatric Device Innovation Symposium and have a chance to leave feedback on your experience? If so, check out the link below and let us know your thoughts on this year's #CTIPSymposium! 📎 https://lnkd.in/eCgD3nUh #RealWorldEvidence #FDA #PediatricInnovation #MedTech Juan Espinoza Melissa Bent