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Learn more about #Velsera #PrecisionMedicine ecosystem that provides #ai powered insights on your lab's patient samples from accessioning to sign out. #NGS #LDT #Genomics #Oncology #Cancer #Research #Bioinformatics #AACR

🚨🚨🚨 Last call to register! Our FREE public meeting led by FDA and the Digital Medicine Society (DiMe) starts tomorrow! Join us on June 26 and June 27, from 11 a.m. to 3 p.m. ET each day. We’ll explore how patient-generated health data (PGHD) can advance remote clinical trial #data collection and facilitate high-quality clinical outcome assessment. 👥 During this 2-day public meeting, you will have the opportunity to learn about and discuss: ▪️ How to implement PGHD throughout the total product life cycle development of medical device development ▪️ Tangible case examples of how PGHD has informed medical devices and can improve return on investment ▪️ How PGHD can help improve health equity by promoting inclusivity in research studies ▪️ Case-based learning on the use of PGHD for medical device developers, scientists, and patients 🔗 Register today and join us for this unique opportunity to learn alongside industry leaders and contribute to future work on resources to advance the use of PGHD in clinical research and regulatory science. https://lnkd.in/ej93__-2 AbbVie ActiGraph Advanced Research Projects Agency for Health (ARPA-H) Bellerophon Therapeutics Clario COPD Foundation Empatica Evidation FasterCures FDA Google HITea With Grace Jackson Heart Study, Koneksa Medable, Inc The Michael J. Fox Foundation for Parkinson's Research National Organization for Rare Disorders Netherlands Organisation for Applied Scientific Research TNO The Light Collective Tidepool Verily VivoSense, Inc. Walgreens Boots Alliance White House Office of Science and Technology Policy WHOOP

Don't miss out! There is still time to register for and join the public meeting, co-led by FDA and Digital Medicine Society (DiMe), sharing insights to support the use of patient-generated health data in medical device development 👉 https://lnkd.in/ej93__-2 We are delighted to be part of this impressive agenda and hope you can join the conversation! 🔷 6/26, 11:30am ET, Jeremy Wyatt will participate in the keynote panel discussion, Vision: 2023: Advancing Clinical Research with Patient-Generated Health Data 🔷 6/27, 1:00pm ET, Christine Cong Guo will present in the session, From Rarity to Clarity: PGHD's Role in Rare Diseases, to share key lessons learned around digital endpoint development #patientcentricity #datacollection #clinicaltrials

Unlock the potential of TriNetX #RealWorldData to construct a comprehensive cohort enriched with clinical data tailored to your trial design. Read our latest blog post for insights on enhancing diversity in your clinical trials! https://ow.ly/zlga30sA018

An important benefit of a good digital protocol solution is the ability to explicitly link study planning to study execution. In other words, unambiguously connect the protocol to downstream processes.    Are you able to create endpoints and eligibility criteria from a high-quality template library? Can you easily demonstrate how protocol endpoints are connected to relevant data collection forms/instruments and vice versa? Let us show you how with the Nurocor Clinical Platform.    Stop by during SCOPE 2024 to learn more – Nurocor Booth 520 #SCOPESummit2024 #SCOPESummit #clinicaltrials #digitalinnovation #automation #digitalhealth #clinicaldevelopment https://lnkd.in/g9N7SgA

🚨 🚨 FDA has qualified the first digital biomarker for use in clinical trials! 🚨 🚨 Here are the details: 🍏 The Apple AFib History Feature was qualified through FDA's Medical Device Development Tools (MDDT) program ⌚ This digital biomarker evaluates estimates of AFib Burden 🔬 It is qualified as a secondary efficacy endpoint in clinical trials of cardiac ablation devices So what does this mean?! The MDDT Program has emerged as the dark horse for the long-awaited big win for digital clinical measures in clinical trials. The FDA's acceptance of digitally measured moderate to vigorous physical activity (MVPA) as the primary endpoint in Bellerophon Therapeutics' Phase 3 clinical trial of INOpulse® for treatment of Fibrotic Interstitial Lung Disease signaled regulatory embrace of high-value, high-quality digital endpoints. But when that therapy didn't perform, the regulatory breakthrough was overshadowed. Today is a straight-up win for all of us that believe in the promise of sensor-based digital health technologies (sDHTs) to transform the way we develop new medical products to better serve the patients our industry exists to serve. Onwards! 🚀 --- If you want to learn more about FDA's MDDT Program and the first qualified digital biomarker (woot!) click here 👉 https://lnkd.in/eN9sRDUK If you want to keep up to date with the first trials to deploy this new endpoint, bookmark The Digital Medicine Society (DiMe)'s library of digital endpoints, update quarterly 👉 https://lnkd.in/eWka-sr4 #digitalhealth #digitalbiomarker #clinical trials

Don't miss RealTime eClinical Solutions latest Site Spotlight featuring EmVenio Research! Phillip Stanford dives into how EmVenio is making a difference in underrepresented communities by establishing clinical trial sites in new areas and utilizing the RealTime-SOMS eClinical suite. Learn more about EmVenio's innovative approach to increasing diversity in clinical trials here:https://hubs.ly/Q02JdT0X0 #ClinicalTrials #DiversityInResearch #EmVenioImpact

We have been collaborating with leading MedTech manufacturers, Notified Bodies and Authoritative Contributors to the EU MDR Guidance to develop a method that is enabling manufacturers to achieve RWE-based EU MDR compliance in a fraction of the time and cost of comparable methods. We are excited to open this collaboration up to other industry leaders with the inaugural RWE-Driven MedTech Summit sessions, being held in Irvine and San Jose California. We hope you can join us, along with our other collaborators to learn how manufacturers are achieving such efficiency, and contribute to the discussion on how to make it more readily attainable throughout our industry! #medtech #medtechinnovation #medtechindustry #eumdr #fda #rwedrivenmedtech

New Year – New Start. Cortex has taken a head-start in 2024 by cooperating with a new clinical study site. This allows us to extend our reach to more patients and perform clinical studies in additional indications. Managing a new site means new challenges and new opportunities, hand-in-hand. This is the first step of this exciting journey and we can’t wait to see where 2024 takes us. #Cortex #SiteManagement #clinicaltrials

With decades of experience and access to integrated data, our Clinical Research team at Carelon Research champions trial goals and navigates complexities that arise along the way. By designing and conducting clinical trials, we answer questions like, “Is this vaccine safe for all people?” or “Is this medical device effective at keeping someone’s heart beating?” Learn more about how our team plans and executes impactful traditional, hybrid, and pragmatic clinical studies across the healthcare continuum: http://bit.ly/3T9lrPv #CarelonResearch #clinicalresearch #pediatricresearch