What is the value of digital endpoints in clinical studies? Their potential is undeniable, the value is significant; and yet, widespread adoption remains a challenge. Koneksa is thrilled to be a part of the official launch of Digital Medicine Society (DiMe)'s new project, "Building the Business Case for Digital Endpoints.” Along with industry partners, we share in the vision that digital endpoints hold the potential to improve the design and execution of clinical trials, making them more patient-centric, data-driven, and adaptable to the evolving needs of clinical research. Learn more here, including signing up to stay up-to-date with this project and be among the first to access the project resources: https://lnkd.in/ej6YnfSi * * * Thank you to all of the collaborators Digital Medicine Society (DiMe), AbbVie, ActiGraph, Biofourmis, BlueSkeye AI, Brain & Mind ltd, CHEO, Chugai Pharma USA, Inc., COPD Foundation, Cosinuss GmbH, Critical Path Institute (C-Path), EVMS Medicine, Evinova, FDA, Genentech, Health Advances, Merck, Mitsubishi Tanabe Pharma America, Modality.AI, OmniScience, Regeneron, Roche, Sama Therapeutics, Sanofi, Seuss+, Strados Labs, SYSNAV Healthcare, Tech Doctor, Inc., TNO, Tufts Center for the Study of Drug Development, UChicago Medicine, VeriSIM Life, WKD.SMRT, Mobilise-D , Cumulus Neuroscience, Imperial College London
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As 2023 draws to a close, I am looking forward to the official launch of Life Science Connect's newest clinical trials community, ClinicalTechLeader.com. Led by Chief Editor Dan Schell and Executive Editor Abby Proch, Clinical Tech Leader is hard launching on January 1st. Mission: Provide solutions, insights, and experiences regarding the technologies that are driving clinical trials to better patient outcomes. The only community entirely dedicated to following the rapid growth and impact of trial technologies. Content themes: Covering the implementation, efficacy, and impact of the physical and digital technologies evolving the clinical trials landscape. (Including Technology Training, Integration, Data Management, Compliance, Regulatory and Quality, Wearable Tech and Remote Monitoring, and Decentralized Trials) #ClinicalTrials #ClinicalTrialTechnology
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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EM resident Stanford| MD/MBA Penn Med and Wharton | Pear VC | Podcast Host of Pear Healthcare Playbook
In my clinical career, I often encounter challenging medical questions where high-quality evidence isn’t always available. As clinicians, we frequently rely on consultations with colleagues, but the reality is that not every clinical decision is backed by gold-standard RCTs. This leaves a gap where many medical decisions lack the robust evidence we strive for. However, there is an opportunity to bridge this gap through real-world data. With vast amounts of real-world evidence, we can make more informed decisions when traditional evidence falls short. That's where companies like Atropos Health step in. Atropos is transforming healthcare decision-making by generating high-quality, personalized real-world evidence in minutes. By leveraging advanced observational research techniques, such as high-dimensional propensity score matching, their platform empowers physicians, researchers, and even pharmaceutical companies to make better, data-driven decisions faster. In the latest episode of the Pear Healthcare Playbook with Pear VC, I had the pleasure of speaking with Neil Sanghavi, President of Atropos Health. We dove deep into his journey into health tech, the role of data in healthcare, and Atropos’ innovative growth strategy. We also explored their go-to-market approach, the creation of ChatRWD, and the critical importance of data quality. Neil shared his vision for the future and some valuable advice for aspiring founders. If this sounds interesting, I’d highly recommend giving the episode a listen and checking out the article. Neil shares some incredible insights! Article: https://lnkd.in/eU7RSfcV Podcast: https://lnkd.in/eekQpdgm
Lessons from Neil Sanghavi, President and Head of Product and Solutions at Atropos on developing publication-grade evidence for healthcare and life sciences
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Unlocking the Future of Clinical Research: Exclusive Insights from Our Partner Company's CEO, Zach Taft, MBA, on Revolutionary Technological Advancements. 🚀💡 “We anticipate more growth and innovation in clinical trials and drug development over the next five years than in the past five decades. This rapid progress is driven by the synergy between these stakeholders and technological advancements. The ultimate beneficiaries of these efforts will be the patients having greater access, global, to life-saving treatments for devastating diseases like cancer. By leveraging the combined strengths and expertise of sponsors, sites, tech companies, and regulatory bodies, we’re creating a more efficient and effective clinical trial ecosystem that holds tremendous promise for the future of healthcare around the world.” #ClinicalResearch #Innovation #EHR #EDC
Remarkable Advances in EDC Systems You Need to Know
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Electronic Clinical Outcome Assessment (eCOA) is revolutionising the way data is collected and analysed in clinical trials. This innovative approach leverages digital technology to gather patient-reported outcomes, clinician-reported outcomes, and observer-reported outcomes, enhancing the efficiency and accuracy of clinical research. Click Link to Learn More > https://lnkd.in/emUrXJ7y
What is eCOA in Clinical Trials?
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Regardless of the clinical trial design, or your personal view on areas of clinical trial inefficiencies and opportunities, advancements like AI and remote health monitoring technology, coupled with decentralized processes, are revolutionizing how we design and conduct trials, enhancing efficiency and patient engagement. Yet, the human touch, like empathy, understanding, and expertise, transforms these trials into meaningful, patient-centric experiences. Integrating technology and human insight is crucial as the biotech sector grows, driven by rapid technological advancements and personalized medicine. This combination streamlines processes and ensures trials are more inclusive and supportive of patient needs. We can accelerate drug development and deliver better healthcare outcomes by embracing this holistic approach. The future success of clinical trials lies in the seamless integration of innovative technology and the irreplaceable value of human expertise, here is where I see great growth and creative ideology. https://lnkd.in/g2tE9GGz
Types of clinical trial designs: The essentials
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🌟 Curious Minds Wanted! 🌟 🚀 How do you see the integration of digital technology revolutionizing the landscape of clinical trials? 💡 In what ways can real-world data (RWD) and real-world evidence (RWE) accelerate the development of new drugs and medical devices? 📈 What challenges do you anticipate in harnessing the power of digitalization for clinical research? 🌐 And most importantly, how can we ensure that patients are at the center of this digital transformation in healthcare? https://lnkd.in/ddNvuWCC Join the conversation and share your insights below!
Using Clinical Trials Digitalization to Optimize Healthcare
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Clinical Trial Liaison | Pre-Launch Medical Affairs | Neurology | Rare Disease | Recruitment and Retention | Husband & Twin Dad
Digital technologies enhance the consent process, with studies showing that #econsent resulting in greater patient comfort and understanding compared to traditional paper-based approaches. This is incredibly encouraging, particularly considering the place of #decentralizedclinicaltrials in the medical research ecosystem! https://lnkd.in/gQwnDT-g
Pilot Study Shows Better eConsents Create Better Human Experiences | BioSpace
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The idea of leveraging novel, sensor-based measures to gather data for clinical trials is not new, but relevant evidence of their usefulness is. Here, Digital Medicine Society (DiMe) experts discuss the impact of digital endpoints on trial success. https://lnkd.in/edJmm3Vk By Sarah Valentine, partnerships lead, and Bert Hartog, VP of sustainability and transformation, Digital Medicine Society (DiMe) #digitalendpoint #clinicaltrials
Shorter, Faster, Cheaper: Powerful New Data On Digital Endpoints
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Check out our interview with Applied Clinical Trials Magazine about the current challenges with the clinical trials landscape and what Yunu does to help. Special thanks to our own Gael Kuhn for joining me and sharing his insights. This is part 1 in a series, so it focuses on first principles of imaging data management needs, lack of workflow, and data loss through the lenses of both sites and sponsors. We have so much work to do - and we need to move faster. The measurable impact of getting this right for patients is stunning! QUESTION: What percentage of site imaging assessments used for determining patients’ trial eligibility and tumor response have errors? (Please post your guess along with any comments and feedback.) I’d like to extend a huge thank you to ACT for deeming our work important and helping make sure these messages are heard. Also, please like and follow Yunu for more real talk about imaging in clinical trials. Enjoy the interview!
Yunu Co-Founders Discuss Challenges Within the Current Landscape of Clinical Trials
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"Real-World Evidence-Ready Datasets: Time for Clinician Engagement" Real World Evidence (RWE) refers to data regarding the usage, benefits, and risks of a medical product derived from real-world sources, such as electronic health records, claims databases, product and disease registries, and patient-generated data. It provides insights into how medical products perform or are used in routine clinical practice outside of controlled clinical trial settings. RWE is increasingly recognized as valuable in healthcare decision-making by regulatory agencies, healthcare providers, payers, and pharmaceutical companies. It can complement evidence from traditional clinical trials by offering insights into the long-term effectiveness and safety of treatments, as well as their real-world impact on patient outcomes, healthcare utilization, and costs. It is necessary for clinicians to become increasingly involved in these types of studies. Luckily, there are companies that are at the forefront of innovation, like MindMaze. Thanks to them, we have begun to carry out a series of clinical cases using #MindMotionGo technology as a #telerehabilitation tool for the recovery of patients with central nervous system injuries, in the chronic phase. Thanks to dedicated and motivated professionals like Patricia Barroso Rodríguez and unique scientists like John Krakauer, we have launched at CEN - Centro Europeo de Neurociencias CENNEURO several intensive treatments in patients' homes, through which we are obtaining invaluable data (an example in the attached document). Analyzing patient recovery under a complex systems theory paradigm allows us to analyze how patients change and the aspects that influence their progression. Assessments cover aspects related to impairment (motor control and strength) with activities, participation and self-perceived quality of life. #MindMotionGo provides detailed information not only quantitative but qualitative, allowing a deeper analysis of how patients are executing the exercises, allowing for finer adjustment of them over the weeks. It is time to abandon the therapeutic reductionism prevailing in neurorehabilitation. It's time to look at the different factors that influence patient recovery and it's time to dedicate more resources to real-world evidence, because that's where rehabilitation happens, that's where recovery happens. Thanks also to the invaluable and dedicated work of Javier Sánchez Aguilar for this project. https://lnkd.in/g9HG6Vpf
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Thanks for highlighting the significance of digital endpoints, Koneksa! We're excited to have you on board for this project.