Maxis Clinical Sciences’ Post

FDA's draft guidance on 𝐩𝐡𝐚𝐫𝐦𝐚𝐜𝐨𝐞𝐩𝐢𝐝𝐞𝐦𝐢𝐨𝐥𝐨𝐠𝐢𝐜𝐚𝐥 𝐬𝐭𝐮𝐝𝐢𝐞𝐬 using real-world data sources sets a new standard for 𝐑𝐞𝐚𝐥-𝐖𝐨𝐫𝐥𝐝 𝐄𝐯𝐢𝐝𝐞𝐧𝐜𝐞. Our latest 𝐧𝐞𝐰𝐬𝐥𝐞𝐭𝐭𝐞𝐫 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.  Read our newsletter for more insight & learn how Maxis Clinical Sciences can support your RWE initiatives! 𝐊𝐞𝐲 𝐓𝐚𝐤𝐞𝐚𝐰𝐚𝐲𝐬: • Study planning and protocol development • Data source selection and evaluation • 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

𝗔𝗿𝗲 𝘁𝗿𝗮𝗱𝗶𝘁𝗶𝗼𝗻𝗮𝗹 𝗰𝗼𝗻𝘁𝗿𝗼𝗹 𝗮𝗿𝗺𝘀 𝘀𝘁𝗶𝗳𝗹𝗶𝗻𝗴 𝘆𝗼𝘂𝗿 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹 𝗽𝗿𝗼𝗴𝗿𝗲𝘀𝘀? ⏰ Yes, there's a smarter way to handle this! Swipe through our carousel to learn about building 𝗘𝘅𝘁𝗲𝗿𝗻𝗮𝗹 𝗼𝗿 𝗦𝘆𝗻𝘁𝗵𝗲𝘁𝗶𝗰 𝗖𝗼𝗻𝘁𝗿𝗼𝗹 𝗔𝗿𝗺𝘀 – a unique approach using real-world data to: • Fast-track your trials and accelerate development timelines. • Expand patient access to potentially life-saving treatments. 𝗗𝗼𝘄𝗻𝗹𝗼𝗮𝗱 𝘁𝗵𝗲 𝗨𝘀𝗲 𝗖𝗮𝘀𝗲 𝗮𝗻𝗱 𝗙𝗮𝘀𝘁-𝗧𝗿𝗮𝗰𝗸 𝗬𝗼𝘂𝗿 𝗧𝗿𝗶𝗮𝗹𝘀! https://lnkd.in/gAS-te9n #ClinicalTrials #ClinicalResearch #SyntheticControlArms #ExternalControlArms #RealWorldData #RealWorldEvidence #Pharma #Biotech #CRO #MaxisClinicalSciences

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

FDA provides new details on Diversity Action Plans for Clinical Trials. Check out this newsletter for quick insights!

The FDA now requires 𝗗𝗶𝘃𝗲𝗿𝘀𝗶𝘁𝘆 𝗔𝗰𝘁𝗶𝗼𝗻 𝗣𝗹𝗮𝗻𝘀 for certain clinical studies. This ensures trials reflect real-world populations, leading to better outcomes for everyone. 𝗥𝗲𝗮𝗱 𝗼𝘂𝗿 𝗻𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿 𝗳𝗼𝗿 𝗶𝗻𝘀𝗶𝗴𝗵𝘁𝘀 & see how Maxis can help! 𝗞𝗲𝘆 𝗧𝗮𝗸𝗲𝗮𝘄𝗮𝘆𝘀: • Plans must set enrollment goals based on factors like age, race, and ethnicity. • These goals need a clear rationale and achievable strategy. #DiversityInClinicalTrials #ClinicalStudies #FDA #MaxisClinicalSciences 𝗦𝗼𝘂𝗿𝗰𝗲: FDA - https://lnkd.in/eT5AhNTP

We are happy to announce the release of our latest whitepaper, "𝐆𝐞𝐧𝐞𝐫𝐚𝐭𝐢𝐧𝐠 𝐒𝐲𝐧𝐭𝐡𝐞𝐭𝐢𝐜 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐚𝐭𝐚: 𝐀 𝐂𝐨𝐦𝐩𝐫𝐞𝐡𝐞𝐧𝐬𝐢𝐯𝐞 𝐀𝐩𝐩𝐫𝐨𝐚𝐜𝐡," authored by Raj Kumar, Principal Consultant, Digital Health at Maxis Clinical Sciences This white paper covers the following insights: 1. 𝐄𝐢𝐠𝐡𝐭 𝐩𝐫𝐢𝐦𝐚𝐫𝐲 𝐦𝐞𝐭𝐡𝐨𝐝𝐬 for generating synthetic medical data, including statistical modeling, bootstrapping, generative models, and simulation models. 2. 𝐂𝐨𝐦𝐩𝐫𝐞𝐡𝐞𝐧𝐬𝐢𝐯𝐞 𝐜𝐨𝐧𝐬𝐢𝐝𝐞𝐫𝐚𝐭𝐢𝐨𝐧𝐬 for medical data synthesis, emphasizing privacy protection, data utility, and regulatory compliance. 3. 𝐃𝐢𝐯𝐞𝐫𝐬𝐞 𝐚𝐩𝐩𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬 of synthetic medical data, ranging from machine learning model training to clinical trial simulations and public health surveillance. 4. 𝐅𝐮𝐭𝐮𝐫𝐞 𝐝𝐢𝐫𝐞𝐜𝐭𝐢𝐨𝐧𝐬 in the field, including advanced generative models, personalized synthetic data, and collaborative data synthesis platforms. Curious? 𝐆𝐞𝐭 𝐲𝐨𝐮𝐫 𝐜𝐨𝐩𝐲 𝐡𝐞𝐫𝐞: https://lnkd.in/gUXMruVR We’d 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

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: • Inform the design of clinical trials, including patient selection, site identification, and power calculations. • Link clinical trial participants to real-world data sources for long-term follow-up and comprehensive outcome assessment. • 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

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?  - 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