Effective #MedicalMonitoring begins long before the first patient is enrolled. In this blog, learn about key considerations for prioritizing patients, engagement between sites and monitors, and synchronizing data for a seamless integration: https://hubs.la/Q03NXnC10 #ClinicalTrials #LifeSciences #ClinicalResearch #ClinChoice #ClinChoiceCanHelp
How to Prioritize Patients and Monitor Clinical Trials Effectively
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At Aranscia, we are universally passionate about our core mission to help unlock the power of precision medicine for everyone. What does that mean in practice? The FDA's recent update to the capecitabine (Xeloda) black box label now carries an explicit recommendation for DPYD PGx testing to help prevent the well-known risks of potentially fatal side effects. Here's how the the Aranscia team turns its passion into immediate action: YouScript's team of research pharmacists and clinical experts went to work immediately reviewing this update, and incorporating the revised warning information into the YouScript knowledgebase. Providers who utilize the YouScript CDS platform were able to instantly gain access to this updated information. YouScript insights are made available for ALL applicable discrete lab results - independent of the originating lab - and help providers to safeguard millions of patient lives. Aranscia's software solutions (2bPrecise and Spesana) can deliver both pre- and post-test guidance for DPYD within their existing provider-centric workflows. These solutions are "0-day" ready and don't require months (or years) of costly configuration or customization. From health systems to independent providers, Aranscia software continues to power unparalleled speed-to-value in building and deploying proactive and/or population-level alerting tailored to the specific need of the providers and their organizations. The AccessDx Laboratory PGx panels already include expanded DPYD variants, and the team has been hard at work supporting oncologists in their adoption of DPYD testing with fast turnaround and integrated ordering workflows. Proven experience in rapid onboarding and provider support has made AccessDx the ideal partner to support large organizations and individual providers alike, with the same consistency of efficient service. Please join me in thanking our entire organization for their continued commitment to advancing intelligent and actionable patient care. I'd also like to acknowledge the tireless efforts of advocacy groups and impacted families to help avoid preventable and potentially fatal adverse events through improved access to DPYD testing, especially Karen Merritt and Advocates for Universal DPD/DPYD Testing.
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PHTI's latest assessment found that virtual OUD solutions deliver clinical outcomes on par with traditional treatment. Pharmacists can be key to connecting more patients to evidence-based tools. Caroline Pearson spoke with Danielle Valletti about the assessment, highlighting the role pharmacists can play in connecting patients to virtual treatment options—ultimately helping individuals access care that may be preferable to traditional in-person visits. Read more in Pharmacy Times: https://lnkd.in/ebE9Ww7m #DigitalHealth #OpioidUseDisorder
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📲 The Digitalization of Clinical Trials: when ePRO transforms research and amplifies the patient’s voice 🌍 A tangible transformation: Digitalization in healthcare is no longer a distant prospect; it is already being implemented within clinical trials. A concrete example is ePRO (electronic Patient-Reported Outcomes). Through ePRO platforms, patients are able to directly document, in real time via tablets or mobile applications, their symptoms, health-related quality of life (HRQoL) questionnaires, and subjective experiences. ✅ Reduced bias compared to paper-based reporting ✅ Improved comfort, autonomy, and adherence for patients ✅ High-quality, real-time data accessibility for investigators ✅ Enhanced data integrity, traceability, and reliability for sponsors ➡ This evolution represents a true paradigm shift: the patient’s voice is no longer peripheral but is now integrated and acknowledged as a validated scientific endpoint by both the FDA and EMA. 🔎 According to Frontiers in Digital Health, the use of ePRO systems in oncology enhances not only the quality of collected data but also patients’ quality of life. 💡 Why does this represent a revolution? ✅ For patients: fewer logistical constraints, improved autonomy, and greater involvement in their care pathway ✅ For investigators: immediate access to robust datasets, reduced transcription bias, and real-time monitoring of clinical trajectories ✅ For sponsors: significant added value through improved data quality, regulatory compliance, and enhanced auditability ✅ For clinical research overall: stronger integration of the patient perspective, reinforcing patient-centered outcomes in treatment development and evaluation 🌍 At FREEARCS PHARMA SERVICES, we are committed to advancing clinical research that is more human, scientifically robust, and truly patient-centered. With the growing digitalization of clinical research and medical practice, could ePRO emerge as the standard for optimizing both care quality and patient experience? #ClinicalResearch #ClinicalTrials #DigitalHealth #ePRO #PatientCentricity #PatientExperience #HealthcareInnovation #DataQuality #PatientReportedOutcomes #HealthData #Oncology #RealWorldEvidence #MedicalTechnology #DigitalTransformation #ConnectedHealth #PatientVoice #RegulatoryCompliance #FutureOfMedicine #EvidenceBasedMedicine #FREEARCSPHARMASERVICES #Digitalisation #EssaisCliniques #ePRO #Innovation #RechercheClinique #PatientsFirst
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The global healthcare IT market is projected to grow from $250 billion in 2020 to nearly $881 billion by 2030 (Allied Market Research), reflecting how rapidly digital innovation is reshaping healthcare. In this context, we’re proud to be featured in Healthcare NOW Radio’s Health IT Product News Report (October 2025), highlighting our recent FDA clearance for CHLOE Blast™ - the first and only FDA-cleared machine learning AI-powered clinical decision support software for embryo assessment. 🔗 Read the full article in the comments. #AIinHealthcare #HealthTech #FertilityCare #FDAclearance #DigitalHealth #CHLOE #IVF #Fairtility
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Germany’s healthcare landscape is witnessing a pivotal development as the Institute for Quality and Efficiency in Health Care embarks on a landmark benefit assessment of Andexanet alfa—a promising antidote for acute major bleeding. 🩸⚕️ Commissioned by the Federal Joint Committee, this rigorous evaluation aims to provide transparent, evidence-based insights into the efficacy of Andexanet alfa, a drug designed to counteract the risks associated with blood thinners in severe bleeding cases. This assessment not only underscores the commitment to advancing patient safety and treatment quality but also holds profound implications for haematology practice and healthcare policy across the nation. Key expectations include potential shifts in clinical protocols, impact on healthcare resource allocation, and enhanced guidance for healthcare providers managing critical bleeding events. As this process unfolds, the findings are poised to shape future medical strategies, reinforcing the importance of robust, methodical evaluations in integrating innovative therapies into standard care. #AndexanetAlfa #GermanyHealthcare #Haematology #HealthPolicy #HealthTechnologyAssessment #HealthcareInnovation #MedicalAssessment #PatientSafety #RegulatoryAgencies #MarketAccess #MarketAccessToday
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By integrating digital tools like ePRO, we can bridge the gap between patients’ lived experiences and clinical research. https://hubs.li/Q03KHl2q0 Written by Avik Pal of CliniOps, Inc
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Specialty #Pharmacotherapy in #LatinAmerica: A Doctor’s Perspective on Regional Challenges and Collaborative Solutions By Dr. Raciel Rizo Nuñez. MD, MD, Regional Medical Director, Latin America, PharmCare Services When it comes to healthcare in Latin America, the conversation often revolves around access, infrastructure, and cost—but few recognize the intricate challenge that lies at the core of ongoing care management: pharmacotherapy. As the #MedicalDirector overseeing several nations in this part of the world, I’ve seen firsthand how medication management—seemingly straightforward in well-integrated health systems—becomes a puzzle of logistical, regulatory, and clinical complexity across borders. Read the full insights here: https://lnkd.in/eRhGPfqj
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The much-anticipated draft Reflection Paper on Patient Experience Data (PED) is here. Too often, patient voices in medicines development are treated as stories, not evidence. That could be about to change. In medicines development and market access, the lived experience of patients can risk being categorised as supplementary narrative rather than critical to decision-making. Patient videos or testimonials that provide a narrow glimpse into the lives of patients but can rarely show the whole landscape. Or late-in-the-day activation of patient advocates to support access, in spite of how much (or little) patients have been part of the development process. But for some time, emphasis from regulators has been shifting towards embedding patient data as evidence rather than just stories. By recognising patient-reported experiences, preferences and outcomes, the approach set out in the European Medicines Agency's paper has the potential to put real rigour around patient experience and make medicines development more inclusive. For underserved communities, where lived experience often goes unheard, this is framework provides potential leverage to shape innovation to better meet the needs of the whole patient population. A core part of Intent Health | B Corp Certified's purpose and our work for the past 5 years. The challenge for everyone working in patient advocacy will be how to operationalise robust data collection across all communities – not just the ones who are easiest to reach - and how best to engage with industry from the earliest phase of clinical development and evidence the value in commercial terms. We are already helping clients to meet this challenge and will be submitting our thoughts to the consultation. If you’re looking for guidance on responding to the consultation, or how to put the right systems in place for the future, let’s connect.
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"Lived experience as evidence rather that just stories" - Our Senior Director Rachel Maconachy shares her thoughts on the European Medicines Agency's draft Reflection Paper on Patient Experience Data (PED) published this week.
Strategic Communications | Advocacy & Engagement | Policy & Public Affairs | Senior Director @ Intent Health
The much-anticipated draft Reflection Paper on Patient Experience Data (PED) is here. Too often, patient voices in medicines development are treated as stories, not evidence. That could be about to change. In medicines development and market access, the lived experience of patients can risk being categorised as supplementary narrative rather than critical to decision-making. Patient videos or testimonials that provide a narrow glimpse into the lives of patients but can rarely show the whole landscape. Or late-in-the-day activation of patient advocates to support access, in spite of how much (or little) patients have been part of the development process. But for some time, emphasis from regulators has been shifting towards embedding patient data as evidence rather than just stories. By recognising patient-reported experiences, preferences and outcomes, the approach set out in the European Medicines Agency's paper has the potential to put real rigour around patient experience and make medicines development more inclusive. For underserved communities, where lived experience often goes unheard, this is framework provides potential leverage to shape innovation to better meet the needs of the whole patient population. A core part of Intent Health | B Corp Certified's purpose and our work for the past 5 years. The challenge for everyone working in patient advocacy will be how to operationalise robust data collection across all communities – not just the ones who are easiest to reach - and how best to engage with industry from the earliest phase of clinical development and evidence the value in commercial terms. We are already helping clients to meet this challenge and will be submitting our thoughts to the consultation. If you’re looking for guidance on responding to the consultation, or how to put the right systems in place for the future, let’s connect.
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