FDA's draft guidance on 𝐩𝐡𝐚𝐫𝐦𝐚𝐜𝐨𝐞𝐩𝐢𝐝𝐞𝐦𝐢𝐨𝐥𝐨𝐠𝐢𝐜𝐚𝐥 𝐬𝐭𝐮𝐝𝐢𝐞𝐬 using real-world data sources sets a new standard for 𝐑𝐞𝐚𝐥-𝐖𝐨𝐫𝐥𝐝 𝐄𝐯𝐢𝐝𝐞𝐧𝐜𝐞.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
Maxis Clinical Sciences
Strategic Management Services
Edison, New Jersey 17,584 followers
Complete Solution for Clinical and Digital Services
About us
We understand that the future of healthcare and life sciences isn't limited to advanced treatments alone but encompasses the creation of a seamlessly integrated ecosystem. At Maxis Clinical Sciences, we recognize that significant progress in healthcare is achieved through the integration of technology, data, & patient-focused approaches. This combination is the basis of our vision for a more efficient & effective healthcare system. In handling the complexities of the Pharma, Biopharma, Biotech, Healthcare, and MedTech industries, our commitment at MCS is to work alongside you to address and surmount these challenges. We combine our expertise with technology-driven solutions and a focus on patient needs, aiming to turn these challenges into innovative solutions. Our strength lies in effectively connecting various elements of healthcare & life sciences. We utilize our extensive experience to develop personalized, technology-enhanced solutions aimed at not just managing medical conditions but improving overall patient well-being. Our range of services includes Real World Evidence (RWE) solutions, data analytics, & strategic management consulting, all geared towards providing care that is tailored to individual patient requirements. Our strategy is to enhance healthcare outcomes through the effective use of data & analytics, coupled with real-world evidence. We aim to empower patients at every step of their healthcare journey, providing them with access to effective treatment strategies. We are dedicated to making high-quality healthcare more affordable & accessible. By optimizing healthcare operations, effectively managing costs, & simplifying the patient experience, we aim to ensure quality care is delivered without causing financial strain. In tackling the complexities of healthcare, we employ digitally enabled, state-of-the-art solutions. These personalized solutions are designed to empower & streamline the experience for everyone involved in the healthcare system.
- Website
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www.maxisclinical.com
External link for Maxis Clinical Sciences
- Industry
- Strategic Management Services
- Company size
- 201-500 employees
- Headquarters
- Edison, New Jersey
- Type
- Privately Held
- Founded
- 2022
- Specialties
- Functional Service Provider, Digital Transformation Services, Strategic Consulting Services, Digital Health, Clinical Services, Clinical Data Management, Biostatistics, Statistical Programming, Central Monitoring, Clinical Study & Project Management, Pharmacovigilance, Regulatory Operations, Medical Writing, Medical Affairs, Translational Medicine, CDISC Standardization, Real World Evidence, Real World Data, Digital Health, Workforce Solutions, Leadership Search, Executive Search, Recruitment Process Outsourcing (RPO), Permanent Talent Excellence, Managed Service Program (MSP) Support, Flexible Resourcing Solutions, Agile Recruitment, Diversity Recruitment, Ad-Hoc Recruitment, Product Lifecycle Management, RWE Studies, HEOR and Market Access, Regulatory and Safety, Drug Product Launch Support, Target molecule identification for acquisition, Potential drug development partners identification, Revenue management, End-to-end support for Mergers and Acquisitions, Real World data transformation, Custom data models, FHIR, OMOP, Advanced ML-based analytics for predictive modelling, Enterprise solutions for data management, Tools for patient and HCP engagement, Tools for business insights, Revenue management tools, Enterprise solutions for portfolio management, Clinical Biometrics Services, Clinical Data Science Services, CDISC Compliance & Data Standardization Services, Clinical Development and Design, Regulatory Strategy, Commercialization Insight, Strategic Roadmap Development, Regulatory and Clinical Affairs, Technology Integration, Clinical Program Planning, Clinical Trial Design and Execution, Regulatory Strategy and Compliance, Evidence-Based Commercialization Planning, Centralized Monitoring, Digital Diagnostics , Diagnostic Tools and Patient Programs, SaMD / Medical Device Software Solutions, and Disease Management Platforms
Locations
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Primary
510 Thornall St
Suite 180
Edison, New Jersey 08837, US
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9 Appold Street
6th Floor
London, England EC2A 2AP, GB
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902, Konark Alpha, Sr No. 50/2
Nagar Road, Kharadi
Pune, Maharashtra 411014, IN
Employees at Maxis Clinical Sciences
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Willie S, MBA♛
Delivery Head | Director Recruitment | Account Manager | Talent Acquisition Manager | Pharma Recruiter | Technology Recruiter | Onboarding Specialist…
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Dipika Das
Director
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Raj Kumar
Principal Consultant - Digi Health | Technology Architect | Ex Accenture - 13 Years | TOGAF® Certified | Exploring GenAI
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Romit Bhalla
Director, Business Development (India) | A Story Teller with Consultative Approach | Process Orientation | Customer Success Vision
Updates
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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
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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 — 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 reposted this
📧 adish.jindal@maxisclinical.com Hiring Home Based : Biostatisticians / SAS/R & Shiny Programmers, Clinical Database Programmers, Laboratory Scientists, Research Associates and Manufacturing Engineers (W2 & C2C)
Hiring for direct major client in #USA !! #Remote #Clinical_Data_Manager (1-5 years), with good experience in #LIMS, #Python, #Excel & (#Java/ #SQL). Please connect: adish.jindal@maxisclinical.com #cdm #clinicaldatamanager #clinicalresearch #cro #pharma #biotech #hiring #bioinformatics #usajobs #remotejobs #wfh Maxis Clinical Sciences
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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 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
Diversity Action Plans Now Required by FDA for Sponsors of Certain Clinical Trials
Maxis Clinical Sciences on LinkedIn
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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
Diversity Action Plans Now Required by FDA for Sponsors of Certain Clinical Trials
Maxis Clinical Sciences on LinkedIn
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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
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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: • 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
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? - 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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