Steven De Hertefelt’s Post

🌟Cross-border Clinical Trials in Europe! 🌟 I’m thrilled to share insights from Ingrid Klingmann, Chairwoman of the European Forum for Good Clinical Practice (EFGCP), about the EU-X-CT - Cross-Border Access to Clinical Trials Initiative This project aims to make it easier for patients across Europe to participate in clinical trials, even if they are held in other countries. 🌍💉 👩⚕️ Dr. Klingmann explains the main challenges patients face, like language barriers, healthcare differences, and high costs. These make it difficult for patients with rare or serious diseases to access new treatments outside their country. 🏥 🔑 What’s EU-X-CT doing? ✅Collecting important info to help patients and doctors understand how cross-border trials work ✅Creating solutions to make it easier for patients to join trials, no matter where they live in Europe 💡 How can you get involved? Patients, doctors, and researchers can join the cause by visiting the EU-X-CT website and sharing their experiences. Every contribution helps! 🙌 🎯🎯🎯Now, I encourage EVERYONE in my network to get involved and support this amazing initiative by completing these questionnaires: 🔹 For CROs/Sponsors and Investigators: https://lnkd.in/etDuGnRu  🔹 For Patients/Caregivers: https://lnkd.in/eCMQkAbF 📝 You don’t need to be an expert—just share your experience! It's perfectly fine to answer "don't know" or "N/A"—every response makes a difference. 🔗 More info: https://lnkd.in/e8Mntgcu ClinicalTrials #CrossBorderTrials #EU-X-CT #Healthcare #Research #PatientCare #Pharma #EFPIA #MedicalResearch #ClinicalResearch #RareDiseases #LifeThreateningConditions #CRO #Sponsors #Investigators #Patients #Caregivers #EUResearch #HealthEquity #ClinicalTrialAccess #MedicalCommunity #GlobalHealth #PharmaceuticalIndustry #HealthResearch #EURegulations #PatientSupport #ResearchInitiative #ClinicalTrialImprovement #HealthPolicy #PharmaceuticalResearch #MedicalAdvancements #HealthcareInnovation #ResearchOpportunities #PatientCenteredCare #HealthChallenges #PatientAssociations #MedicalSocieties #ClinicalTrialOrganizations #CROs #ClinicalResearchOrganizations #PharmaIndustry #MedicalAssociations #HealthAdvocacy #PatientEngagement #EUClinicalTrials #Pharmaceuticals #PatientCareAdvocacy #RareDiseaseResearch ##PharmaCollaborations #ClinicalTrialAccess #EuropeanClinicalTrials @EFPIA @EuropeanPatientsForum @EuropeanOrganisationforRareDiseases @EORTC @EHA @ESMO @EASL @EULAR @ESCRS @ISPOR @AstraZeneca @Novartis @Roche @Pfizer @Sanofi @GSK @Merck @Johnson & Johnson @Bristol-Myers Squibb @Eli Lilly @AbbVie @Amgen @Celgene @Biogen @Takeda @Regeneron @Sanofigenzyme @Boehringer Ingelheim @Mylan @Sandoz @ViiV Healthcare @Novo Nordisk @Teva Pharmaceuticals @Horizon Therapeutics @NICE @Orphanet @Duchenne Foundation @Cystic Fibrosis Foundation @Muscular Dystrophy Association @Rare Disease UK @European Hemophilia Consortium @National Organization for Rare Disorders

🌍 Ukrainian Clinical Trials: Resilience, Effectiveness, and Strategic Opportunities We are excited to share the outcomes of a recent webinar organized by the UACR (Ukrainian Association for Clinical Research), the State Expert Center of the Ministry of Health, and international experts. The webinar highlighted Ukraine’s role as a rising leader in the global clinical trials landscape. Despite ongoing challenges, Ukraine’s clinical trials continue to demonstrate resilience and effectiveness. This discussion emphasized the strategic opportunities for growth in the industry, supported by a robust infrastructure and dedicated professionals. Special thanks to the international speakers for their valuable insights on the future of clinical research in Ukraine! 🔗 Read more here: https://lnkd.in/d67NCaM3 Let’s continue driving innovation and showcasing Ukraine’s potential in clinical trials! 🇺🇦 #ClinicalTrials #Ukraine #ClinicalResearch #HealthcareInnovation #Resilience

🌍 Celebrate Clinical Trials Day with Us! 🌍   Learn about the importance of clinical research and see how Dimension Research, as the largest CRO in Pakistan is making a difference. Watch our video to find out more!   🔬 Watch the Video Now 👇 #ClinicalTrialsDay2024 #ClinicalResearch #CRO #DimensionResearch

🚨 New report from the The Assistant Secretary for Planning and Evaluation (ASPE) on COVID-19 and clinical trials references IQVIA Institute’s report, Lesson Learned from COVID-19 Vaccine Trials: A CRO perspective on accelerating clinical development. The report explores the impact of the pandemic on clinical trials and highlights key lessons learned. Download it here: https://bit.ly/4dIZ2lD #COVID19 #ClinicalTrials #GlobalHealth

I disagree with the premise that “patient centricity” is the key for clinical trial optimisation. Clinical trials involve multiple stakeholder groups, each with their own objectives and interests. Like any system, optimum performance depends on alignment and interaction between parties. Focusing on any one party as the central focus, may seem beneficial at first glance, but is ultimately self limiting. Why grease only one cog? A more powerful approach is stakeholder collaboration and alignment around three guiding principles: A shared objective: Regardless which area of the clinical trial process we operate, we all need to take accountability for promoting and affirming the fact that our shared objective is to advance human health. We all have unique roles to play with their own challenges; however we need to remember we are all part of a big team pulling and pushing in the same direction. Of course this is also true patient centricity. Innovation and Flexibility: The clinical trial landscape is constantly evolving. A commitment to exploring innovative approaches, and new ways of doing things, is critical to our success. I don’t just mean focusing on the latest trends like adaptive trial designs, DCT or AI. Instead adopting and fundamental commitment to doing the simple things in a better way. This means continuously seeking out efficiencies, streamlining processes, and eliminating unnecessary burdens for all stakeholders. By constantly questioning the status quo and embracing a culture of continuous improvement, we can optimise the entire clinical trial process. Transparency and Trust: Open communication and clear expectations throughout the trial process build trust and foster a collaborative environment. Regular updates, transparent reporting of progress and challenges, and ensuring all stakeholders are informed and involved in decision-making processes are crucial. Transparency helps mitigate misunderstandings, aligns everyone’s efforts toward the common goal, and creates a sense of shared responsibility and trust among all parties. If we all commit to focusing on these three principles it will allow us to make real, sustainable progress…together. Outsourcing in Clinical Trials Event Series #clinicaltrials #health #clinicalresearch #biotech

🔬 The deadline for stakeholder’s feedback on UE joint clinical assessment is getting closer : April 2nd  ! ⏰ 🇪🇺 By changing the landscape of decision-making in health technology assessment (HTA) and harmonizing HTA practices across the European Union, the regulation (EU) 2021/2282, aims to enhance the availability of healthcare interventions for patients. 🤝 Implemented within this framework, the Joint Clinical Assessment (JCA) process to standardize the evaluation of medications and medical devices across all EU Member States, thereby abandoning the necessity for multiple national HTA entities to undertake redundant systematic reviews of clinical evidence. 📆 It’s scheduled to begin with the evaluation of oncology drugs and advanced therapy medicinal products (ATMPs) on January 12, 2025, followed by orphan drugs in January 2028, and extending to include all healthcare interventions by 2030. This process represents a significant step forward in promoting efficiency and coherence within HTA practices throughout the European Union. ⏰ The EU's HTA Regulation marks a significant milestone in shaping the future of healthcare and waits for your feedback until April 2nd. 💬 Let's seize this opportunity to shape a healthier future for all Europeans together! 💊 link : https://lnkd.in/eEg3QQsz

Your IMP is ready for its clinical phase but how do you progress to FiH studies as quickly, and painlessly, as possible? With MHRA metrics for CTA assessments within their target timeline, acting now might just give you a head start on your competitors.

Brazil by the Numbers: A Thriving Hub for Clinical Trials With a population exceeding 212 million people, Brazil is uniquely positioned to be a leader in clinical research. Our country boasts over 1,200 trial sites, and currently hosts over 1,800 active clinical trials. Notably, this figure represents only 3% of the global total, underscoring a vast opportunity for expansion. Brazil is well-suited to receive new clinical trials, specially in areas such as #Oncology and #RareDiseases, where there ie low or no competitive landscape. This presents a significant opportunity to advance innovative treatments and contribute to global healthcare advancements. For organizations considering where to initiate their next clinical trial, Brazil offers the infrastructure, expertise, and diverse patient population necessary for success. To learn more about Brazil and LATAM as a destination for clinical trials, please write to us at bd@odclifesciences.com. #ClinicalTrials #Brazil #HealthcareInnovation #ClinicalResearch Sources: ClinicalTrials.Gov / ANVISA

🌟 Looking to budget your clinical trial efficiently? 🌟 Check out our Clinical Trial Cost Calculator! 🔗 How to budget Clinical Trials: https://lnkd.in/ek4MC2RG #ClinicalTrials #ClinicalResearch #BudgetonClinicalTrial

Get a clear estimate of your clinical trial expenses with our Clinical Trial Cost Calculator. Designed to provide quick, tailored cost insights, it's a helpful tool for planning your next trial with precision. Read How to Budget Clinical Trials: https://lnkd.in/ek4MC2RG Explore it here: 👇👇👇