One2Treat’s Post

Real-world diversity demonstrates how different patients respond to treatments. Without this representation, trial efficacy can fall short. Join experts from Biogen, Tufts Center for the Study of Drug Development, ICON plc, and Cognivia on December 4 for a webinar exploring Diversity Action Plan strategies—from improving patient recruitment and retention to reducing data variability. In the webinar, you will learn: ✅ The importance of a coherent and comprehensive diversity action plan-integrated approach ✅ Valuable insights from regulatory, industry and academic leaders ✅ How to mitigate the data variability impact on clinical trial data interpretation when implementing a diversity action plan Register today: https://lnkd.in/eAmrbDAF

Top 5 Challenges of Managing Clinical Trials As a practice in the life sciences industry, clinical trials are essential for developing new drugs and treatment methods. https://lnkd.in/d87WMMYZ

Discover the art of fast-tracking drug development with Miami Clinical Research! In our newest blog, we unveil the tactics and tools driving our success in expediting clinical trials. Join us as we navigate the complex landscape of medical research, delivering efficient and impactful solutions that shape the future of healthcare. Don't miss out—click the link below to uncover the science behind our strategies: https://lnkd.in/gm6mHD7D #medicalresearch #clinicaltrials #medicalstudies #miamiclinicalresearch #drugdevelopment #clinicalresearch #pharmaceuticalresearch #healthcare #drugtrials

Excited to share my latest article on clinical trial supply management! 📈🥼 Clinical trials are becoming more challenging in line with the increased complexity of investigational drugs that focus on personalized medicine, smaller patient populations and rarer indications. In this article, I dive into the 4 top trends influencing this space, and how to de-risk your supply chain. Read the full article here 👉 https://lnkd.in/e2VQcQqB #clinicaltrials #drugdevelopment  

The Food and Drug Omnibus Reform Act (FDORA) will work to ensure accurate representation in clinical trials. But how can pharmaceutical companies achieve this standard if it is not already a priority?    Jennifer Byrne, Irfan Khan, MD and Marie Rosenfeld say technology could help find an answer.     As Byrne says, “I strongly believe this new space will enable us to work more effectively with the immense quantity of data available through health systems and use AI optimizations to reach those known patient populations. We start with such a wide funnel; this empowers us to get it down to where we can predict those known patients. I think AI can help us address the ethical, moral, and public health responsibility we must reach these patients with. Our inability to do so thus far is at the heart of the problem today.”    Hear more insights from these industry leaders below: https://lnkd.in/e6nfTa7c #clinicaltrials #patientengagement #patientsupport #patientcentricity #patientfocused

FDORA calls for greater diversity of patients in research. What do you see as the root causes preventing diverse populations currently and how can we reduce these? I think about how often I go to the doctor (which is not enough), but I would be much more inclined to complete a telehealth call and save a few hours in the commute time alone. We need this same thought process in clinical trials using modern technology and practices to go direct to the patients. If we can do this, we can start to attract a wider population.

Shedding light on the significant cost involved in bringing new medicines to market, with a staggering median of nearly $1 billion. Surprisingly, only a small fraction, less than 14%, of clinical trial therapies manage to secure approval from the FDA. To enhance their success rates, sponsors must consider strategic actions, and technology emerges as a crucial component in this equation. #clinicaltrial #eClinical #IRT #eConsent #eCOA #ePRO #technology

The bold new #innovative solution offered by S-CLINICA integrates Randomization and Trial Supply Management (RTSM) into a single platform. This unique combination brings multiple advantages to sponsors and clinical trial teams: - **BUDGET CONTROL**: This platform reduces supply chain budgets by minimizing overstocking and emergency shipments. - **IMPROVED TRIAL OUTCOMES**: Real-time data synchronization ensures patients receive the correct medication on time, reducing risk. - **ENHANCED VISIBILITY**: Sponsors can access a comprehensive overview of trial progress and supply metrics on a single dashboard, driving data-driven decision-making. - **SCALABILITY**: This platform can accommodate trials of any scale, from early-phase studies to large complex global multi-center trials. S-CLINICA's consolidation of RTSM and supply forecasting streamlines clinical trial management significantly. The platform's customization capability allows for timely trial launches within budget, maintaining quality and compliance. By enhancing process efficiency and data accuracy, S-CLINICA enables sponsors to focus on delivering impactful therapies to patients. Please, reach out to me directly if you’d like to learn more about how S-Clinica’s platform can simplify your next study. Thanks for sharing with your #network #RTSM #supplyforecasting #clinicaltrialmanagement #radiopharmaceuticals #celltherapey #oncology #innovation #technology #management #AI #FDA #clinicaltrials #healthcare #medicine #biotech #pharma #RTSM #supplyforecasting #supplychainmanagement #CDMO #CRO #SCLINICA

Clinical Trials Market Worth $73.2 Billion by 2028  ☑️𝐃𝐨𝐰𝐧𝐥𝐨𝐚𝐝 𝐏𝐃𝐅 𝐁𝐫𝐨𝐜𝐡𝐮𝐫𝐞:https://lnkd.in/d2u3bTSZ The global clinical trials market in terms of revenue was estimated to be worth $48.2 billion in 2023 and is poised to reach $73.2 billion by 2028, growing at a CAGR of 8.7% from 2023 to 2028. 🔵𝐓𝐡𝐞 𝐜𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 𝐟𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐢𝐧 𝐭𝐡𝐢𝐬 𝐫𝐞𝐩𝐨𝐫𝐭 𝐢𝐧𝐜𝐥𝐮𝐝𝐞 Thermo Fisher Scientific IQVIA ICON plc Laboratory Corporation of America Holdings Syneos Health WuXi AppTec Charles River Laboratories PAREXEL International (India) Private Ltd Fortrea Medpace Frontage Laboratories, Inc ACM Global Laboratories Advanced Clinical PSI CRO AG Bioagile Therapeutics Pvt Ltd CTI Clinical Trial and Consulting Services Worldwide Clinical Trials Pepgra Clinical Research Organization (CRO) for Medicines and Healthcare products CTI CLINICAL TRIAL AND CONSULTING SERVICES UK LTD Dove Quality Solutions Firma Clinical Research Celerion Novotech Linical

Public Health Priority: CDRH Announces Office Reorganization to Boost Agility and Advance Mission The FDA's CDRH, led by Director Jeff Shuren, has announced organizational changes to enhance its public health mission. The Office of Communication and Education has been elevated to a Super Office, now called the Office of Communication, Information Disclosure, Training, and Education, which includes new divisions for Digital Communication and Marketing. These changes aim to improve stakeholder communication and education. Additionally, the Office of Product Evaluation and Quality will see structural changes, with new divisions in the Office of Clinical Evidence and Analysis and Office of Health Technology 4 to better align with stakeholder needs. For more details please click the link! https://lnkd.in/gu6ne_Y7 #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical