The FDA now requires ๐๐ถ๐๐ฒ๐ฟ๐๐ถ๐๐ ๐๐ฐ๐๐ถ๐ผ๐ป ๐ฃ๐น๐ฎ๐ป๐ for certain clinical studies. This ensures trials reflect real-world populations, leading to better outcomes for everyone. ๐ฅ๐ฒ๐ฎ๐ฑ ๐ผ๐๐ฟ ๐ป๐ฒ๐๐๐น๐ฒ๐๐๐ฒ๐ฟ ๐ณ๐ผ๐ฟ ๐ถ๐ป๐๐ถ๐ด๐ต๐๐ & see how Maxis can help! ๐๐ฒ๐ ๐ง๐ฎ๐ธ๐ฒ๐ฎ๐๐ฎ๐๐: โข Plans must set enrollment goals based on factors like age, race, and ethnicity. โข These goals need a clear rationale and achievable strategy. #DiversityInClinicalTrials #ClinicalStudies #FDA #MaxisClinicalSciences ๐ฆ๐ผ๐๐ฟ๐ฐ๐ฒ: FDA - https://lnkd.in/eT5AhNTP
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FDA's draft guidance on ๐ฉ๐ก๐๐ซ๐ฆ๐๐๐จ๐๐ฉ๐ข๐๐๐ฆ๐ข๐จ๐ฅ๐จ๐ ๐ข๐๐๐ฅ ๐ฌ๐ญ๐ฎ๐๐ข๐๐ฌ using real-world data sources sets a new standard for ๐๐๐๐ฅ-๐๐จ๐ซ๐ฅ๐ ๐๐ฏ๐ข๐๐๐ง๐๐. Our latest ๐ง๐๐ฐ๐ฌ๐ฅ๐๐ญ๐ญ๐๐ซ details the important aspects of the guidance, including study planning and the development of the protocol, data source selection and evaluation, and statistical analysis and its interpretation.ย Read our newsletter for more insight & learn how Maxis Clinical Sciences can support your RWE initiatives! ๐๐๐ฒ ๐๐๐ค๐๐๐ฐ๐๐ฒ๐ฌ: โข Study planning and protocol development โข Data source selection and evaluation โข Statistical analysis and interpretation #RealWorldData #RealWorldEvidence #RWD #RWE #Pharmacoepidemiology #FDA #ICH #MaxisClinicalSciences Visit our website to know more: https://lnkd.in/guPia6AB Source: https://lnkd.in/emnPG43v
FDA Announces Draft Guidance on RWD in Pharmacoepidemiological Studies
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๐๐ฟ๐ฒ ๐๐ฟ๐ฎ๐ฑ๐ถ๐๐ถ๐ผ๐ป๐ฎ๐น ๐ฐ๐ผ๐ป๐๐ฟ๐ผ๐น ๐ฎ๐ฟ๐บ๐ ๐๐๐ถ๐ณ๐น๐ถ๐ป๐ด ๐๐ผ๐๐ฟ ๐ฐ๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐๐ฟ๐ถ๐ฎ๐น ๐ฝ๐ฟ๐ผ๐ด๐ฟ๐ฒ๐๐? โฐ Yes, there's a smarter way to handle this! Swipe through our carousel to learn about building ๐๐ ๐๐ฒ๐ฟ๐ป๐ฎ๐น ๐ผ๐ฟ ๐ฆ๐๐ป๐๐ต๐ฒ๐๐ถ๐ฐ ๐๐ผ๐ป๐๐ฟ๐ผ๐น ๐๐ฟ๐บ๐ โ a unique approach using real-world data to: โข Fast-track your trials and accelerate development timelines. โข Expand patient access to potentially life-saving treatments. ๐๐ผ๐๐ป๐น๐ผ๐ฎ๐ฑ ๐๐ต๐ฒ ๐จ๐๐ฒ ๐๐ฎ๐๐ฒ ๐ฎ๐ป๐ฑ ๐๐ฎ๐๐-๐ง๐ฟ๐ฎ๐ฐ๐ธ ๐ฌ๐ผ๐๐ฟ ๐ง๐ฟ๐ถ๐ฎ๐น๐! https://lnkd.in/gAS-te9n #ClinicalTrials #ClinicalResearch #SyntheticControlArms #ExternalControlArms #RealWorldData #RealWorldEvidence #Pharma #Biotech #CRO #MaxisClinicalSciences
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Maxis Clinical Sciences wishes you a Happy Fourth of July! It's a day filled with tradition, but let's not forget the significance โ a celebration of America's independence! Here's to honoring the past and building a brighter future. #4thOfJuly #FourthofJuly #USIndependenceDay #MaxisClinicalSciences
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Maxis Clinical Sciences celebrates our incredible doctors today! Their passion and commitment to patient care inspire us every day. Thank you for all you do! "Healing Hands, Caring Hearts." #Doctors #NationalDoctorsDay #ThankYouDoctors #MaxisClinicalSciences
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FDA provides new details on Diversity Action Plans for Clinical Trials. Check out this newsletter for quick insights!
The FDA now requires ๐๐ถ๐๐ฒ๐ฟ๐๐ถ๐๐ ๐๐ฐ๐๐ถ๐ผ๐ป ๐ฃ๐น๐ฎ๐ป๐ for certain clinical studies. This ensures trials reflect real-world populations, leading to better outcomes for everyone. ๐ฅ๐ฒ๐ฎ๐ฑ ๐ผ๐๐ฟ ๐ป๐ฒ๐๐๐น๐ฒ๐๐๐ฒ๐ฟ ๐ณ๐ผ๐ฟ ๐ถ๐ป๐๐ถ๐ด๐ต๐๐ & see how Maxis can help! ๐๐ฒ๐ ๐ง๐ฎ๐ธ๐ฒ๐ฎ๐๐ฎ๐๐: โข Plans must set enrollment goals based on factors like age, race, and ethnicity. โข These goals need a clear rationale and achievable strategy. #DiversityInClinicalTrials #ClinicalStudies #FDA #MaxisClinicalSciences ๐ฆ๐ผ๐๐ฟ๐ฐ๐ฒ: FDA - https://lnkd.in/eT5AhNTP
Diversity Action Plans Now Required by FDA for Sponsors of Certain Clinical Trials
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We are happy to announce the release of our latest whitepaper, "๐๐๐ง๐๐ซ๐๐ญ๐ข๐ง๐ ๐๐ฒ๐ง๐ญ๐ก๐๐ญ๐ข๐ ๐๐๐๐ข๐๐๐ฅ ๐๐๐ญ๐: ๐ ๐๐จ๐ฆ๐ฉ๐ซ๐๐ก๐๐ง๐ฌ๐ข๐ฏ๐ ๐๐ฉ๐ฉ๐ซ๐จ๐๐๐ก," authored by Raj Kumar, Principal Consultant, Digital Health at Maxis Clinical Sciences This white paper covers the following insights: 1. ๐๐ข๐ ๐ก๐ญ ๐ฉ๐ซ๐ข๐ฆ๐๐ซ๐ฒ ๐ฆ๐๐ญ๐ก๐จ๐๐ฌย for generating synthetic medical data, including statistical modeling, bootstrapping, generative models, and simulation models. 2. ๐๐จ๐ฆ๐ฉ๐ซ๐๐ก๐๐ง๐ฌ๐ข๐ฏ๐ ๐๐จ๐ง๐ฌ๐ข๐๐๐ซ๐๐ญ๐ข๐จ๐ง๐ฌย for medical data synthesis, emphasizing privacy protection, data utility, and regulatory compliance. 3. ๐๐ข๐ฏ๐๐ซ๐ฌ๐ ๐๐ฉ๐ฉ๐ฅ๐ข๐๐๐ญ๐ข๐จ๐ง๐ฌย of synthetic medical data, ranging from machine learning model training to clinical trial simulations and public health surveillance. 4. ๐ ๐ฎ๐ญ๐ฎ๐ซ๐ ๐๐ข๐ซ๐๐๐ญ๐ข๐จ๐ง๐ฌ in the field, including advanced generative models, personalized synthetic data, and collaborative data synthesis platforms. Curious? ๐๐๐ญ ๐ฒ๐จ๐ฎ๐ซ ๐๐จ๐ฉ๐ฒ ๐ก๐๐ซ๐: https://lnkd.in/gUXMruVR Weโd love to hear your thoughts on this important topic. Please feel free to share your insights in the comments below and join the discussion. For any queries, please get in touch with Raj Kumar, Principal Consultant. #SyntheticMedicalData #DigitalHealth #DataPrivacy #MachineLearning #ClinicalTrials #PublicHealth #HealthTech #FutureOfHealthcare #MaxisClinicalSciences Dr. Kavita Lamror | Shibra Tupke | Khooshbu Singh | Sneha Gupta Press Release: https://lnkd.in/gxgt5mpb
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In honor of #CancerSurvivors month, Dr. Kavita Lamror at Maxis Clinical Sciences shares her expertise on the importance of integrating Real-World Evidence in Oncology. Watch the video to learn how it can help understand underrepresented populations, rare cancers, and long-term treatment toxicities, and facilitate faster and more accessible treatments. Dr. Kavita Lamror discusses how RWE can: โข Inform the design of clinical trials, including patient selection, site identification, and power calculations. โข Link clinical trial participants to real-world data sources for long-term follow-up and comprehensive outcome assessment. โข Generate synthetic patient populations using advanced analytics to model treatment effects and optimize healthcare decision-making. Regulatory bodies are now acknowledging the value of RWE for informing oncology research and development. Integration of RWE with traditional RCTs holds promise for a more efficient and effective approach. Share your thoughts in the comment section! Visit: https://lnkd.in/gzbviB-z #CancerSurvivors #RealWorldEvidence #MaxisClinical
As we express solidarity with #CancerSurvivors this month, we continue to explore new modalities of evidence generation from #realworlddata. Sharing my thoughts on optimising RWE for faster and widely accessible Oncology treatments. #RWE #MCS
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The FDA recently announced an update on the Payor Communication Task Force, which facilitates communication between medical device manufacturers and payors (insurance companies) to expedite patient access to innovative medical devices. Source: https://lnkd.in/gcmX2FBf The task force offers two programs: 1. Early Payor Feedback Program (EPFP): Allows manufacturers to receive feedback from payors on clinical trial design and data collection to support coverage decisions. 2. Parallel Review: Enables the FDA and CMS to review clinical trial data simultaneously, reducing the time between FDA approval and CMS coverage determination. The impact?ย - Manufacturers can design clinical trials to meet both regulatory and payor requirements, potentially expediting patient access. - Payors can provide input on data requirements, enabling them to make informed coverage decisions. - Patients may gain faster access to innovative medical devices. We support this effort from FDA by providing Real World Evidence (RWE) solutions that deliver actionable insights, support strategic decision-making, and improve patient outcomes. Visit our website to learn more about our RWE offerings: https://lnkd.in/gDeXU5YD Interested in discussing RWE projects? Schedule a consultation with Khooshbu Singh, our Business Development Director, RWE & Digital Transformation: https://lnkd.in/gj6P9yqV #FDAUpdate #MedicalDevice ##PayorCommunicationTaskForce #RealWorldEvidence #RWE #MaxisClinicalSciences
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