As a result of FDA guidance released earlier this month, we are re-sharing "Decentralised Clinical Trials: Achieving our Ambition?", first published by our #Synetic colleagues in 2023. "This remains an incredibly challenging space for biopharmaceutical companies. There is a stakeholder consensus that decentralised elements will benefit many patients. However, regulatory, legal, logistical and ethical considerations have resulted in a more cautious adoption. This paper discusses the challenges and proposes critical success factors for conducting decentralised elements within the clinical trial setting." Steve Gunnigle (Lead Author and Vice President, Consulting at #Synetic) Matthew McLoughlin Mary Alice Dwyer Neil Croft Synetic Life Sciences #ClinicalDevelopment #ClinicalOperations #Biopharmaceutical #DecentralisedClinicalTrials #DecentralizedClinicalTrials #DCT #FDA
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Biopharma Consultant and Certified Professional Coach specializing in Leadership, Culture, Innovation, and Transformation
Excellent paper; kudos for the team for robustly capturing the current landscape; challenges, and considerations for DCT implementation. The "promise" of DCT is still present; with more pragmatic approaches that continue to move the industry forward in a meaningful way for patients.
As a result of FDA guidance released earlier this month, we are re-sharing "Decentralised Clinical Trials: Achieving our Ambition?", first published by our #Synetic colleagues in 2023. "This remains an incredibly challenging space for biopharmaceutical companies. There is a stakeholder consensus that decentralised elements will benefit many patients. However, regulatory, legal, logistical and ethical considerations have resulted in a more cautious adoption. This paper discusses the challenges and proposes critical success factors for conducting decentralised elements within the clinical trial setting." Steve Gunnigle (Lead Author and Vice President, Consulting at #Synetic) Matthew McLoughlin Mary Alice Dwyer Neil Croft Synetic Life Sciences #ClinicalDevelopment #ClinicalOperations #Biopharmaceutical #DecentralisedClinicalTrials #DecentralizedClinicalTrials #DCT #FDA
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Clinical trial vendors can be a boon to your research and biopharmaceutical success but without a proper vendor oversight program in place, mistakes are bound to happen. It might sound challenging, but establishing vendor oversight is easier than you think! In a recent guest column for Clinical Leader, Megan Lile of Liles Clinical Trials Consulting, lays out a blueprint for achieving successful collaboration between sponsors, CROS, and third-party vendors. Understanding how each CRO monitors performance and keeping everyone in the loop can help your vendor relationships thrive. Click through to learn more: Source: https://hubs.li/Q02CnMKg0 #clinicaltrialvendors #vendorrelationships #biopharmaceutical #vendoroversight #governancestructures #communication #vendorstrategy
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💊 Clinical trials are crucial for developing new medications and treatments, but navigating the complex world of international research can be daunting. Thanks to its efforts to further strengthen and enhance its well-established clinical research sector, #Serbia is rising as a reliable and efficient location. This dynamic nation offers a wealth of advantages for #pharmaceutical companies and research institutions. 📖In this Insight we look at 9 compelling reasons to consider Serbia for your next clinical trial: https://lnkd.in/edN3whpi #ClinicalTrials
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Celebrating Clinical Trials Day, an occasion to honor the remarkable contributions of the research community to revolutionizing healthcare with new medicines and therapies. With over 7500 PK/PD Studies completed, 265+ Late-Phase #ClinicalTrials conducted, and 1400+ Validated Bioanalytical Methods, Lambda Therapeutic Research & Novum Pharmaceutical Research Services are honored to have made significant contributions to the field of #ClinicalResearch. We thank volunteers, patients, healthcare providers, sponsors, regulators, and research professionals for their contributions to advancing #healthcare and improving patient outcomes. Together, let's continue pushing boundaries and transforming patient outcomes! #LambdaTherapeuticResearch #LambdaResearch #ClinicalTrialsDay #ICTD2024 #RevolutionizingHealthcare #ClinicalResearch #MedicalResearch #Innovation #clinicaldevelopment #DrugDevelopment #NovumPharmaceuticalResearchServices #pharmaceutical #research #NovumPRS #novumresearch
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Delve into the transformative power of FDA Fast Track and Accelerated Approval pathways in our latest post! Learn how these pathways revolutionize drug development, speeding up reviews and ensuring earlier access to critical treatments in healthcare. Explore the implications for pharmaceutical companies and patients alike. Dive deeper into the complexities and controversies surrounding these pathways and how DS InPharmatics can guide you. Don't miss out on unlocking the potential of expedited pathways! Read more: https://lnkd.in/eUcxvM5d #FDA #FastTrack #AcceleratedApproval #Pharmaceuticals #Healthcare #DSInPharmatics
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Head QREC CRO (India-UAE) with Planning to execution experience in drugs and devices till date with 36000+ doctors and 540K patient database and still ongoing in REAL WORLD | PMS | Global studies |Phase 4| Registries etc
QREC Team (India-UAE) wishes everyone International Clinical Trial Day [ICTD] which is celebrated globally on May 20th. Thanks to Healthcare Industry including pharmaceuticals, lifesciences, biotech, medical device etc. and all the stakeholders involved in the conduct and participants in clinical trials. #pharmaceuticals #clinicalresearch #clinicaldatamanagment #statisticalanalysis #medicalwriting #ICTD2024 #ISCR #medicaldevice #biotech
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By leveraging human tissue testing, researchers are revolutionizing the drug development process! This innovative approach provides invaluable insights into drug efficacy and safety much earlier in the development timeline. Not only does this proactive strategy accelerate the entire process, but it also significantly boosts the chances of clinical success. Imagine the impact: faster drug development, improved safety profiles, and ultimately, better treatments for patients. This is a game-changer for the pharmaceutical industry and healthcare as a whole. #drugdiscovery #drugdevelopment #humantissuetesting
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Discover the impact of FDA Fast Track & Accelerated Approval pathways! Speed up drug development and ensure quicker access to treatments. Let DS InPharmatics guide you through. #FDA #FastTrack #AcceleratedApproval #DSInPharmatics
Delve into the transformative power of FDA Fast Track and Accelerated Approval pathways in our latest post! Learn how these pathways revolutionize drug development, speeding up reviews and ensuring earlier access to critical treatments in healthcare. Explore the implications for pharmaceutical companies and patients alike. Dive deeper into the complexities and controversies surrounding these pathways and how DS InPharmatics can guide you. Don't miss out on unlocking the potential of expedited pathways! Read more: https://lnkd.in/eUcxvM5d #FDA #FastTrack #AcceleratedApproval #Pharmaceuticals #Healthcare #DSInPharmatics
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🌟 Join Circuit Clinical for an enlightening webinar series on enhancing participant representation in research through community-based clinical trials! 💡 The first webinar in the series explores Circuit Clinical’s Community Research Network and the impact of community #healthcare on accelerating drug development and medical innovation. 🎤 Featured speakers will delve into: ➔ The significance of community-based research in the pharmaceutical landscape ➔ How community-based research sites differ from traditional models ➔ Challenges and considerations for pharmaceutical sponsors and CROs ➔ Factors to weigh when selecting a community research site 🔗 REGISTER HERE: https://buff.ly/3uP4XEq ⭐ Featured speakers: Alaina Anderson, MBA Elizabeth Seyfert Laura Warwick #DrugDevelopment #ClinicalResearch #PatientRecruitment #ClinicalSites #PatientParticipation
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𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰 𝗣𝗼𝘀𝗶𝘁𝗶𝗼𝗻𝗶𝗻𝗴 𝗳𝗼𝗿 𝗮 𝗡𝗲𝘄 𝗗𝗿𝘂𝗴 In the ever-evolving world of clinical treatments, a pharmaceutical industry leader faced a challenge: adapting its messaging to meet the changing needs of European physicians. 💊 We, at Jasper Colin, stepped in to help them create a strategic positioning for their new drug, ensuring it stood out in a competitive landscape. 💡 Our strategic positioning efforts gave the drug a competitive edge, making it a preferred choice among European physicians. 🏆 Read the full report to dive deeper into our methodology and discover how we transformed the drug's market positioning. 🔗 #JasperColin #DatatoDecision #StrategicPositioning #pharmaceuticalindustry #ClinicalTreatments #drugmanufacturing
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