Discover how it’s possible to tailor RTSM to meet specific precision medicine challenges of expiry, visit & personalized shipment management during Perceptive Inc.'s webinar discussion on December 12th! ?? Reserve your spot: https://lnkd.in/et_sih6q ??? Speaker: Malcolm Morrissey, Associate Director, Statistical Design & Trial Supplies Consultant, Perceptive Inc.
Clinical Leader
制药业
Erie，Pennsylvania 15,723 位关注者
A resource and forum to investigate and resolve the common struggles related to running effective clinical trials.
关于我们
The landscape of the life sciences industry is as vast and varied as the professionals who work in it. Some online resources aim to serve the entire space. We wish them luck. Instead, our goal is to be the most valuable resource for a specific segment of the industry – clinical research & trials – and the professionals who make their living there. The Clinical Leader community is not made up of generalists. They’re specialists, like us. We deliver in-depth content from authoritative authors and sources because that’s what our community demands. Our editors connect with and interview top clinical executives from pharmaceutical and biotech companies who share best practices, challenges faced and overcome, clinical trends, partnering strategies, and experiences implementing new technologies. Additionally, our Clinical Leader Live series of live events provides an interactive forum where sponsor companies talk about some of today's biggest challenges when managing clinical trials. Even better, the audience gets to ask questions during the presentation.
- 网站
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https://www.clinicalleader.com/
Clinical Leader的外部链接
- 所属行业
- 制药业
- 规模
- 51-200 人
- 总部
- Erie，Pennsylvania
- 创立
- 1995
- 领域
- Clinical Trials和CRO
动态
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Join us on December 12th to learn how RTSM can be tailored to meet precision medicine’s unique challenges of expiry, visit & personalized shipment management! Register here for the discussion: https://lnkd.in/eqxxZq7J ? Explore?case studies?sharing Perceptive Inc.'s experience of delivering: -Cell and gene therapy (CGT) studies? -Radiopharmaceutical studies ? Plus,?learn how a good RTSM can support associated challenges?of: -Oncology and rare disease designs -Innovative trial designs of adaptive & master protocols -Medication pooling and JIT -Sourcing differences -High unblinding risk
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Discover how remote cardiac monitoring technology is enabling the pharmaceutical industry to shift towards innovative, efficient, and patient-friendly clinical trials. https://lnkd.in/e99CPxib Source:?AliveCor
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WEBINAR: On December 10th, explore the most critical steps companies can take to prevent trials from reaching a point of crisis and the importance of addressing systemic issues before they escalate. ?? Reserve your?spot for the discussion: https://lnkd.in/djCh7H8H ??? Speakers: Raul Lima, Executive Vice President of Clinical Operations, inSeption Group Dawn Niccum, Executive Vice President of QA & Compliance, inSeption Group May Orfali, MD, Chief Medical Officer Executive
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In this week's issue, we'll cover the FDA's latest version of Bioresearch Monitoring Technical Conformance Guide: Technical Specifications Document, the benefits of the new ICH M11 guideline, Alexion's nuanced way of looking at diversity, why effective oversight is critical for companies addressing Form 483 observations, and other popular insights! Peter Calcott, calcott consulting | Jessica Jolly | Adrian Kielhorn, Alexion Pharmaceuticals, Inc., AstraZeneca | Lyn Agostinelli, Halloran Consulting Group, Inc. | Dan Schell, Jess Thompson, MS, MBA, PMP | Aaron Grant, Cencora | Pharma solutions | Julie Blasingim, Univo IRB | Perceptive Inc. | Teri Crumb, TLC Research, LLC | ActiGraph
FDA Issues Bioresearch Monitoring Technical Specifications Document, Alexion Rethinks Diversity Metrics, and More
Clinical Leader，发布于领英
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Following these five key lessons when planning and implementing clinical trial operations in low- and middle-income countries will lead you to more successful outcomes. https://lnkd.in/dWCViEpr By Caitlin Ciavarro, Bill & Melinda Gates Medical Research Institute
Clinical Trial Operations In Low- And Middle-Income Countries: 5 Keys To Success
clinicalleader.com
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With 25 years of global data science experience, Jessica Jolly gives a quick overview of the ICH M11 guideline and talks about some specifics of its two pillars: standardization and automation. https://lnkd.in/dApWrESZ
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Jess Thompson, MS, MBA, PMP is a champion of project managers. Not only is she working to validate their role in the clinical trial ecosystem, she wants to spread the word that we all perform PM-types of duties. View her discussion with Chief Editor Dan Schell: https://lnkd.in/eBeZ3axR
We Are All Project Managers, But We Need Help
clinicalleader.com
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Explore how effective oversight is critical for companies addressing Form 483 observations identified during clinical study site regulatory inspections. https://lnkd.in/empCEGVS By Lyn Agostinelli, Halloran Consulting Group, Inc.
483 Issues To Sites – Indicators Of Sponsor Oversight Effectiveness
clinicalleader.com
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Do you know how to identify the early warning signs of clinical trial derailment? Join us on December 10th to explore the most critical steps companies can take to prevent trials from reaching a point of crisis and the importance of addressing systemic issues before they escalate. ?? Secure your?spot for the discussion: https://lnkd.in/efH3yqwS ?? Key Learning Objectives: ? Discover the root causes behind clinical trial setbacks and how to address them proactively ? Understand how to identify early warning signs of trial derailment and mitigate risks before they escalate ? Learn practical solutions that can make an immediate and significant impact on everyday processes? ? Examine real-world case studies where early intervention prevented trial failure and ensured long-term success
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