🚀 𝐋𝐚𝐮𝐧𝐜𝐡𝐢𝐧𝐠 𝐌𝐲𝐭𝐡 𝐕𝐬 𝐅𝐚𝐜𝐭 𝐒𝐞𝐫𝐢𝐞𝐬 There are so many myths surrounding Clinical Trials, their processes, and even some of the roles within the industry! These misconceptions can create confusion and mislead people, which is why I’m launching a special series called "𝐌𝐲𝐭𝐡𝐬 𝐯𝐬 𝐅𝐚𝐜𝐭𝐬" to share some of the most common myths vs the fact. For the next 𝐭𝐰𝐨 𝐰𝐞𝐞𝐤𝐬, I’ll be sharing insights on various myths that are often believed to be true in the world of clinical research—whether it’s about trial designs, monitoring, or the responsibilities of clinical roles. 𝐇𝐞𝐫𝐞 𝐢𝐬 𝐭𝐡𝐞 𝐟𝐢𝐫𝐬𝐭 𝐩𝐨𝐬𝐭 𝐟𝐫𝐨𝐦 𝐭𝐡𝐞 𝐬𝐞𝐫𝐢𝐞𝐬! 💡 𝐑𝐢𝐬𝐤-𝐁𝐚𝐬𝐞𝐝 𝐌𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠 (𝐑𝐁𝐌) has been a significant shift in the world of clinical trials over the past few years, moving away from traditional on-site monitoring to a more data-driven and targeted approach. RBM focuses on identifying, assessing, and mitigating risks throughout the clinical trial process, allowing sponsors to prioritize critical data points and sites for oversight. As the industry recognized its efficiency and effectiveness, RBM gained immense visibility and adoption across trials globally. However, with this growing adoption, misconceptions and myths have also emerged, often due to a lack of understanding or experience with this model. 𝐇𝐞𝐫𝐞 𝐚𝐫𝐞 𝐭𝐡𝐞 𝐭𝐨𝐩 𝐓𝐇𝐑𝐄𝐄 𝐦𝐲𝐭𝐡𝐬 I've encountered during conversations with professionals. 𝐈’𝐝 𝐥𝐨𝐯𝐞 𝐭𝐨 𝐡𝐞𝐚𝐫 𝐲𝐨𝐮𝐫 𝐭𝐡𝐨𝐮𝐠𝐡𝐭𝐬 𝐚𝐧𝐝 𝐞𝐱𝐩𝐞𝐫𝐢𝐞𝐧𝐜𝐞𝐬—𝐬𝐡𝐚𝐫𝐞 𝐲𝐨𝐮𝐫 𝐢𝐧𝐬𝐢𝐠𝐡𝐭𝐬, 𝐞𝐱𝐩𝐞𝐫𝐢𝐞𝐧𝐜𝐞𝐬, 𝐨𝐫 𝐛𝐮𝐬𝐭 𝐬𝐨𝐦𝐞 𝐦𝐲𝐭𝐡𝐬 𝐲𝐨𝐮𝐫𝐬𝐞𝐥𝐟! #clinicalresearch #qualitymanagementsystem #goodclinicalpractices #ICHGCP #Riskbasedmonitoring #RBM #remote #MythsVsFacts #GCP #ClinicalTrials #Monitoring #ClinicalDesign #remoteMonitoring #GlobalClinicalTrials #Quality #QualityAssurance
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📊 Transform Your Clinical Research with Centralized Monitoring! 🧬✨ Are you ready to elevate the efficiency and accuracy of your clinical trials? Centralized monitoring (CM) is the innovative approach you need. 📈 Why Choose Centralized Monitoring? Increased Efficiency: Reduce on-site monitoring visits by up to 50% 🚀 Enhanced Data Quality: Identify data discrepancies and trends swiftly, reducing error rates by 30% 📉 Cost-Effective: Save up to 25% on overall trial costs 💸 Improved Compliance: Ensure adherence to protocols and regulatory requirements 📋✅ Faster Results: Achieve a 20% reduction in trial timelines ⏱️ At CR Integration, we pride ourselves on a 0% turnover rate of Clinical Research Associates (CRAs), ensuring consistency and exceptional data quality throughout your clinical trials. 🔗 Learn more about how Centralized Monitoring can revolutionize your clinical research by reaching out to us at melinda@crintegration.com. #ClinicalResearch #CentralizedMonitoring #DataQuality #ClinicalTrials #Efficiency #Innovation #Healthcare #ResearchExcellence #CostSavings 💡 Join the future and enhance the efficiency and accuracy of your clinical trials with Centralized Monitoring by CR Integration! 💡
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Obtaining informed consent in clinical research should be not only simple but a priority in our industry. Far too often, however, it is a headache. With long paper forms that slow down trials and cost precious resources. Participants get confused, frustrated, and discouraged from participating altogether. And that means missed opportunities for every stakeholder. Imagine a smoother process. With Clinical.ly's eConsent services, sites and sponsors can: Go paperless, streamline processes, and save countless person-hours of time. Ensure 21 CFR compliance with validated and established systems. Customizes forms that meet the changing needs of our sites, sponsors, and studies. Clinical.ly's systems are designed to adapt to your workflow that give #YouControl Transform your eConsent expectations to the quality they deserve. And stop letting paper hold you back. Reach out to Clinical.ly today and elevate your clinical trials. Let’s work together to make informed consent easier, faster, and more effective for everyone in the industry. #eConsent; #Clinically; #ClinicalTrials; #ClinicalResearch; #21CFRCompliant;#YouControl
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🚀 Do more with Clinical.ly! 🚀 At Clinical.ly, we’re dedicated to empowering clinical research sites and advancing the way studies are conducted. With the Clinical.ly Research Suite™ eConsent functionality , we have provided a powerful tool that lets sites fully own and manage the patient consent process. This streamlined solution reduces complexity, saves time, and, most importantly, enhances the patient experience by putting control right into the hands of those who matter most. Thrilled to see how Clinical.ly continues to evolve in ways that make a real impact on the lives of patients, researchers, and healthcare providers alike. Check out more about our eConsent in our latest post and learn how we’re helping make consent a seamless, patient-friendly process🌟 #ClinicalResearch #Innovation #eConsent #Clinically #Patientfirst #clinicaltrials #PatientCentricity #eSource #DigitalHealth #youreincontrol
Obtaining informed consent in clinical research should be not only simple but a priority in our industry. Far too often, however, it is a headache. With long paper forms that slow down trials and cost precious resources. Participants get confused, frustrated, and discouraged from participating altogether. And that means missed opportunities for every stakeholder. Imagine a smoother process. With Clinical.ly's eConsent services, sites and sponsors can: Go paperless, streamline processes, and save countless person-hours of time. Ensure 21 CFR compliance with validated and established systems. Customizes forms that meet the changing needs of our sites, sponsors, and studies. Clinical.ly's systems are designed to adapt to your workflow that give #YouControl Transform your eConsent expectations to the quality they deserve. And stop letting paper hold you back. Reach out to Clinical.ly today and elevate your clinical trials. Let’s work together to make informed consent easier, faster, and more effective for everyone in the industry. #eConsent; #Clinically; #ClinicalTrials; #ClinicalResearch; #21CFRCompliant;#YouControl
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Clinical trials at AMCs and health networks face unique challenges, especially during the start-up phase. Traditional, paper-based regulatory documentation often slows things down, creating bottlenecks in a complex, multi-layered process. Our latest blog unpacks eReg/eISF systems can speed up clinical trial start-up times, reduce administrative burdens, and improve compliance, allowing trials to operate with unprecedented efficiency. Here’s a quick preview of the key benefits: →Faster Start-Up Timelines: eReg/eISF reduces protocol review time by centralizing and automating document management, cutting study start-up timelines by up to 20% for our clients. Say goodbye to physical handovers and fragmented systems! →Improve Compliance & Audit Readiness: With automated audit trails and version control, eReg/eISF ensures that all regulatory requirements are met without extra hassle. In fact, RealTime users report 5x more inspection readiness with eReg/eISF platforms. →Better Stakeholder Collaboration: eReg/eISF enables real-time document sharing, making it easier for AMCs, sponsors, and regulatory agencies to stay aligned. Remote access and eSignatures further facilitate smooth workflows and uninterrupted operations. →Integrated Systems for Seamless Operations: eReg/eISF integrates easily with other clinical trial management systems, allowing better coordination and faster document retrieval, leading to 75% reduced monitoring costs in among many RealTime clients. 🔗 Check out the full breakdown on how eReg/eISF can accelerate clinical trial cycle times right here: https://lnkd.in/g2J7FChd #ClinicalTrials #eReg #eISF #Efficiency #Compliance #BetterData
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Clinical trials at AMCs and health networks face unique challenges, especially during the start-up phase. Traditional, paper-based regulatory documentation often slows things down, creating bottlenecks in a complex, multi-layered process. Our latest blog unpacks eReg/eISF systems can speed up clinical trial start-up times, reduce administrative burdens, and improve compliance, allowing trials to operate with unprecedented efficiency. Here’s a quick preview of the key benefits: →Faster Start-Up Timelines: eReg/eISF reduces protocol review time by centralizing and automating document management, cutting study start-up timelines by up to 20% for our clients. Say goodbye to physical handovers and fragmented systems! →Improve Compliance & Audit Readiness: With automated audit trails and version control, eReg/eISF ensures that all regulatory requirements are met without extra hassle. In fact, RealTime users report 5x more inspection readiness with eReg/eISF platforms. →Better Stakeholder Collaboration: eReg/eISF enables real-time document sharing, making it easier for AMCs, sponsors, and regulatory agencies to stay aligned. Remote access and eSignatures further facilitate smooth workflows and uninterrupted operations. →Integrated Systems for Seamless Operations: eReg/eISF integrates easily with other clinical trial management systems, allowing better coordination and faster document retrieval, leading to 75% reduced monitoring costs in among many RealTime clients. 🔗 Check out the full breakdown on how eReg/eISF can accelerate clinical trial cycle times right here: https://lnkd.in/e5wS9c2E #ClinicalTrials #eReg #eISF #Efficiency #Compliance #BetterData
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Clinical trials at AMCs and health networks face unique challenges, especially during the start-up phase. Traditional, paper-based regulatory documentation often slows things down, creating bottlenecks in a complex, multi-layered process. Our latest blog unpacks eReg/eISF systems can speed up clinical trial start-up times, reduce administrative burdens, and improve compliance, allowing trials to operate with unprecedented efficiency. Here’s a quick preview of the key benefits: →Faster Start-Up Timelines: eReg/eISF reduces protocol review time by centralizing and automating document management, cutting study start-up timelines by up to 20% for our clients. Say goodbye to physical handovers and fragmented systems! →Improve Compliance & Audit Readiness: With automated audit trails and version control, eReg/eISF ensures that all regulatory requirements are met without extra hassle. In fact, RealTime users report 5x more inspection readiness with eReg/eISF platforms. →Better Stakeholder Collaboration: eReg/eISF enables real-time document sharing, making it easier for AMCs, sponsors, and regulatory agencies to stay aligned. Remote access and eSignatures further facilitate smooth workflows and uninterrupted operations. →Integrated Systems for Seamless Operations: eReg/eISF integrates easily with other clinical trial management systems, allowing better coordination and faster document retrieval, leading to 75% reduced monitoring costs in among many RealTime clients. 🔗 Check out the full breakdown on how eReg/eISF can accelerate clinical trial cycle times right here: https://lnkd.in/gaKtKbvJ #ClinicalTrials #eReg #eISF #Efficiency #Compliance #BetterData
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The journey from a groundbreaking medical discovery to a life-changing treatment is complex and challenging. For many emerging and mid-sized companies, navigating the clinical research landscape is a daunting task. These companies often grapple with limited resources, complex regulatory requirements, and the pressure to maintain high standards. These challenges can slow down their progress and impact their ability to deliver innovations to the patients who need them. InSiGHt Health Clinical Ltd is here to bridge that gap. As a premier clinical service firm and Contract Research Organization (CRO), we provide end-to-end support across the clinical operations process. Our tailored and comprehensive solutions are designed to meet emerging and mid-sized companies' unique needs, ensuring excellence in quality, integrity, and service. By partnering with us, companies can confidently advance their research, knowing they have a trusted partner committed to their success and improving patient care.
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Are you tired of unexpected roadblocks and delays in your clinical trial projects? 🚧 𝐒𝐲𝐬𝐭𝐞𝐦𝐬 𝐭𝐡𝐢𝐧𝐤𝐢𝐧𝐠 offers a powerful framework to navigate the complexities of #clinicaltrials. By understanding how different components of your project interact and influence one another, you can: 🔍 𝐈𝐝𝐞𝐧𝐭𝐢𝐟𝐲 𝐚𝐧𝐝 𝐚𝐝𝐝𝐫𝐞𝐬𝐬 𝐫𝐢𝐬𝐤𝐬 before they escalate into major issues. 🧠 𝐈𝐦𝐩𝐫𝐨𝐯𝐞 𝐝𝐞𝐜𝐢𝐬𝐢𝐨𝐧-𝐦𝐚𝐤𝐢𝐧𝐠 by considering the broader implications of your choices. 🤝 𝐄𝐧𝐡𝐚𝐧𝐜𝐞 𝐜𝐨𝐥𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐢𝐨𝐧 among team members and stakeholders. Here's a quick guide to applying #systemsthinking to your clinical trial project: 1️⃣ 𝐃𝐞𝐟𝐢𝐧𝐞 𝐭𝐡𝐞 𝐬𝐲𝐬𝐭𝐞𝐦: Clearly outline the boundaries of your project and its key components (e.g., patients, sites, regulatory bodies, data management). 2️⃣ 𝐀𝐧𝐚𝐥𝐲𝐳𝐞 𝐫𝐞𝐥𝐚𝐭𝐢𝐨𝐧𝐬𝐡𝐢𝐩𝐬: Understand how these components interact and influence one another. Consider factors like patient recruitment, site performance, and regulatory approval processes. 3️⃣ 𝐈𝐝𝐞𝐧𝐭𝐢𝐟𝐲 𝐟𝐞𝐞𝐝𝐛𝐚𝐜𝐤 𝐥𝐨𝐨𝐩𝐬: Look for positive and negative feedback loops that can amplify or mitigate changes. For instance, a delay in patient enrollment could lead to higher costs and extended study timelines. 4️⃣ 𝐂𝐨𝐧𝐬𝐢𝐝𝐞𝐫 𝐞𝐦𝐞𝐫𝐠𝐞𝐧𝐭 𝐩𝐫𝐨𝐩𝐞𝐫𝐭𝐢𝐞𝐬: Be mindful of unexpected outcomes from component interactions. For example, a Protocol change might inadvertently impact patient retention. By adopting a 𝐬𝐲𝐬𝐭𝐞𝐦𝐬 𝐭𝐡𝐢𝐧𝐤𝐢𝐧𝐠 approach, you can: ⚡ 𝐈𝐧𝐜𝐫𝐞𝐚𝐬𝐞 𝐩𝐫𝐨𝐣𝐞𝐜𝐭 𝐞𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐜𝐲 by anticipating and mitigating potential challenges. 🏆 𝐈𝐦𝐩𝐫𝐨𝐯𝐞 𝐩𝐫𝐨𝐣𝐞𝐜𝐭 𝐪𝐮𝐚𝐥𝐢𝐭𝐲 by ensuring all components are aligned and working together seamlessly. 🙌 𝐄𝐧𝐡𝐚𝐧𝐜𝐞 𝐬𝐭𝐚𝐤𝐞𝐡𝐨𝐥𝐝𝐞𝐫 𝐬𝐚𝐭𝐢𝐬𝐟𝐚𝐜𝐭𝐢𝐨𝐧 by demonstrating a holistic understanding of the project's complexities. Curious to learn more about applying systems thinking to clinical trial projects? Connect with us for more information. #clinicalprojectmanagement #drugdevelopment #clinicalstudies #projectmanagement #riskmanagement
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🚨 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧, 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐚𝐧𝐝 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞 𝐟𝐨𝐫 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬 📅 November 5-7, 2024 at 8:00AM CST // 9:00AM EST // 2:00PM GMT 🔊 Listen below to gain insight into what the event will entail! We’re thrilled to announce that Matthias Fink, Senior Clinical Consultant at AKRA TEAM, participated in a pre-event conversation with our event producer, Chloe Culver. 🌐 Learn More: https://bit.ly/4dzIU5m Matthias Fink will join us on November 7 as the chairperson of the day and will present a session titled "Delving into Data: Is All Data Sufficient?" He will cover: - Clinical data requirements – US vs EU - Is there a difference in expectation across regions? - How is sufficient data defined? - Ensuring sufficient data is collected - Can you leverage data from previous devices or other regions? - Examples of rectifying insufficient data 🌐 Download Brochure: https://bit.ly/4dteOAZ 👉 Register Now & 𝐒𝐚𝐯𝐞: https://bit.ly/3yxju9A #medtech #medicaldevices #regulations #clinicaevaluations #clinical #software #mdr #fda #PCCP #ISO13485 #RWE #PMS #eSTARs #lifesciences #informa
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Echoing Max's excitement to launch HTA Vision! A powerful new tool for market access executives and teams to be empowered with the latest insights and intelligence from the world of global HTA. Join our webinar on June 13th to learn more. #HTA, #MarketAccess
A number of critical manufacturer activities are informed by understanding health technology assessment (HTA) agency behavior across geographies and therapeutic areas—from pipeline, business development and licensing to launch planning preparation through to lifecycle management strategy. Join Maximilian Hunt, a Partner in Trinity Life Sciences’ Evidence, Value, Access & Pricing Practice, as he hosts a lively discussion on the benefits of rapid access to cumulative, compounded learnings generated from in-depth analysis of global HTA recommendations, with presenters Mary Fletcher-Louis, Managing Director & Head of Trinity’s Value Center of Excellence and Andreia Ribeiro, Associate Principal. Register now: https://bit.ly/4bP8OBh
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