George Stuts

🔍 Biostatisticians: The Data Guardians of Clinical Trial Success! In clinical trials, data integrity isn’t just a priority—it’s essential. In our latest blog, Erin Mathias, Senior Director of Global Biostatistics at Veristat, shares her insights into how biostatisticians ensure that trial data is valid, reliable, and ready to drive impactful decisions. From designing rigorous studies to conducting in-depth analyses, discover how these experts safeguard data quality and empower sponsors to make informed choices. 📖 Explore the critical role of biostatistics in clinical research: https://lnkd.in/ggFQhRcb #ClinicalTrials #Biostatistics #DataIntegrity #VeristatInsights #ClinicalResearch

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Streamline Your Clinical Study Reporting with SAS https://lnkd.in/dspdTqta Clinical trials are a cornerstone of medical advancements, but generating comprehensive reports can be a challenge. This blog post dives into how Clinical SAS can streamline your clinical study reporting process. Let us explore:  💁‍♂️ What clinical study reports are and their significance 💁‍♂️ Key ICH E3 requirements for clinical study reporting 💁‍♂️ Best practices for clinical SAS programming Generating high-quality clinical study reporting is essential for regulatory submissions and scientific communication. SAS can help you achieve this efficiently and effectively. #ClinicalResearch #SAS #ClinicalTrialReporting #ClinicalDataManagement

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How do you think about data quantity vs. data quality when it comes to RWD? COTA's Sandy Leonard recently sat down with Karla Feghali, MBA of Deloitte and shared how the quantity-versus-quality question has evolved in clinical research. "When RWE was emerging, companies were focused on accessing as much data as they could. The idea was that if you had the entire haystack, you were bound to find the couple of needles that were important for your study. For years, data buyers and researchers were focused almost entirely on quantity. I think the industry has evolved significantly as companies have gained more exposure to different types of data and now have technologies that can help improve the quality of the data. A company no longer needs to start with a large quantity in order to get to quality. Targeted data from the right 300 patients might be more useful than a cohort of 10 million patients." https://lnkd.in/dX8euKAF #rwd #realworlddata #oncologyresearch

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What is Clinical Data Science (CDS)? How does it differ from Clinical Data Management (CDM)? Where can I find CDS references? 🤔 If you're asking these questions, the "Clinical Data Science 101" free on-demand webinar is here to demystify what Clinical Data Science is and what it is NOT. Patrick Nadolny, SCDM Chair, leads you through everything you need to know to stay ahead of the evolution from #CDM to #CDS. Tune in today to discover everything about Clinical Data Science and its main drivers. ➡️ https://lnkd.in/ehVqWXWW

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📊 In our recent poll, "𝘦𝘹𝘵𝘦𝘳𝘯𝘢𝘭 𝘥𝘢𝘵𝘢 𝘮𝘢𝘯𝘢𝘨𝘦𝘮𝘦𝘯𝘵" was voted the most challenging aspect of clinical data management (CDM). The #IDDI data managers also recognizes that the management of external data can be a challenging process, especially as data requirements go very often beyond the samples for biochemistry and hematology analysis and requires working with numerous vendors, some being of small size and not having the procedures and resources of a multinational central laboratory. In that context, and to mitigate the risks of an incorrect #CRF design, or a postponed #databaselock, our data managers have a list of points to discuss with the vendors to better understand their processes/ procedures. This allows us to have the best understanding possible of the data in question, to implement the most efficient reconciliation process possible and support our client in that sometimes difficult journey. ✔️ For more insights on the complex landscape of clinical data management and the pivotal role of experienced data managers, check out our latest blog "The Evolving Role of Clinical Data Managers in Patient-Centric Clinical Trials." at: https://lnkd.in/e9QvmRE3 Written by Véronique Spoo, IDDI's Director Clinical Data Management #biometrics #cro #CDM #clinicaldata #datamanagement #EDC #trialdesign

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In the world of clinical reporting, precision and presentation are key. Amarex Clinical Research Director, Harika Myneni, shares key insights on leveraging SAS Output Delivery System (ODS) with Rich Text Format (RTF) to enhance data tables, listings, and final reports. With customizable styles, advanced formatting options, and cross-platform compatibility, ODS RTF ensures professional, publication-ready outputs that streamline regulatory submissions. Learn more in this article: https://lnkd.in/gNPShydA #ClinicalResearch #SASProgramming #ClinicalReporting #ODSRTF #RegulatoryCompliance #DataVisualization #ClinicalTrials #Biostatistics #PharmaTech #DataManagement #HealthcareInnovation #RTF #DataQuality

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The FDA recently released a draft guidance offering best practices for common questions received by the Office of Therapeutic Products (OTP). Read the summary by Cencora's Louis Cicchini and Cori Gorman in @DrugDiscoveryDev here: https://ow.ly/nnBG50UnO7y

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The obstacles and opportunities in preserving data integrity have intensified as electronic clinical outcome assessment (eCOA) technologies become more prevalent. YPrime explains the challenges facing clinical data integrity and the solutions and best practices for effective data monitoring. https://bit.ly/3D2g8gz

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#Biostatistics services help #ClinicalTrials ensure the scientific validity, reliability and accurate interpretation of data. However, a sponsor or contract research organization (#CRO) may need to outsource these services on a project or study basis. Here are four reasons third-party biostatistics services are a good idea. ➡️ https://bit.ly/3TAcDDE

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📣 OneOncology's Oncology Quality Hub has been approved by CMS as both a Qualified Clinical Data Registry (QCDR) and a Qualified Registry (QR). 🔍 This designation reflects OneOncology’s ability to meet rigorous federal standards for collecting and submitting clinical data on behalf of healthcare providers as part of CMS’s Quality Payment Program (QPP). ⛏️ As a CMS-approved QCDR and QR, OneOncology can now collect clinical data from a variety of sources and report MIPS measures for partner clinicians and practices regardless of their EMR provider, streamlining quality reporting and driving improved performance. 🩺 As a QCDR, OneOncology is now also authorized to develop new quality measures that CMS can recognize and incorporate into the MIPS program. ⬇️ Check out the news release. https://lnkd.in/ewZEn28n

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📊 Learn how Tableau, a data visualization and analytics tool, can be leveraged to enhance #pharmacovigilance practices and improve patient safety. Signal management plays a crucial role in identifying potential safety concerns and evaluating the efficacy of drugs. Read more at: https://hubs.li/Q02sY2jk0 Interested in learning about our Safety and PV solutions? Read more here: https://hubs.li/Q02sX_cR0 #CTMS #eTMF #EDC #RTSM #Safety #PV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials #Tableau #Salesforce Salesforce

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📊 Learn how Tableau, a data visualization and analytics tool, can be leveraged to enhance #pharmacovigilance practices and improve patient safety. Signal management plays a crucial role in identifying potential safety concerns and evaluating the efficacy of drugs. Read more at: https://hubs.li/Q02sY0Yg0 Interested in learning about our Safety and PV solutions? Read more here: https://hubs.li/Q02sY0Ws0 #CTMS #eTMF #EDC #RTSM #Safety #PV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials #Tableau #Salesforce

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📊 Leveraging #Tableau for Real-Time Signal Management: A Solution for Drug Safety and Efficacy 📊 This resource highlights how Tableau, a data visualization and analytics tool, can be leveraged to enhance #pharmacovigilance practices and improve patient safety. Signal management plays a crucial role in identifying potential safety concerns and evaluating the efficacy of drugs. Read more at: https://hubs.li/Q02w0kYX0 #CTMS #eTMF #EDC #RTSM #Safety #PV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials #Tableau #Salesforce Salesforce

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