Warren English

Risk identification, assessment, and mitigation are important steps in your #IRT system setup. Learn Calyx's structured process for identifying risks across the #ClinicalTrial lifecycle. Read the blog. https://lnkd.in/eaV_GEPD #RTSM #ClinicalTrials #ChooseCalyx

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Join our discussion at DIA in San Diego led by Mike Wierzba on the impact of IVDR and FDA’s final LDT rule on local and central testing. https://lnkd.in/ecQTnfuZ

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Computerized systems are the backbone of modern manufacturing and quality control processes. They're also essential in clinical trials, where they manage and analyze critical patient data. 💻 This whitepaper explores the applicable guidelines and regulations across different environments (GCP, GLP, GMP) that must be adhered to for effective computer system validation, and how GAMP5 can ensure compliance across these regulatory frameworks. ✅ Download this whitepaper to learn how to effectively validate your computerized systems. 👇 https://lnkd.in/ejN9VdZ8 #ComputerizedSystems #GAMP5 #GCP #GLP #GMP

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Computerized systems are the backbone of modern manufacturing and quality control processes. They're also essential in clinical trials, where they manage and analyze critical patient data. 💻 This whitepaper explores the applicable guidelines and regulations across different environments (GCP, GLP, GMP) that must be adhered to for effective computer system validation, and how GAMP5 can ensure compliance across these regulatory frameworks. ✅ Download this whitepaper to learn how to effectively validate your computerized systems. 👇 https://lnkd.in/ejN9VdZ8 #ComputerizedSystems #GAMP5 #GCP #GLP #GMP

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Risk identification, assessment, and mitigation are important steps in your #IRT system setup. Learn Calyx's structured process for identifying risks across the #ClinicalTrial lifecycle. Read the blog. https://lnkd.in/eSRETbRC #RTSM #ClinicalTrials #ChooseCalyx

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If you don't know about SMART IRB, you need to. This organization developed a pathway for sites with a local IRB to streamline the process to rely on another institution or central IRB. There are 1200+ institutions that have agreed to use this agreement when relying on an external IRB. This saves days even months in study start up. Univo knows fast, and knows that being part of SMART IRB accelerates connecting patients to research. If you'd like to know more, email info@univo-group.com.

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Just finished the course “A Design Thinking Approach to Putting the Customer First” by Big Think! Check it out: https://lnkd.in/eNiUctHh #customerfocuseddesign.

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There's been an alarming rise in cybersecurity vulnerabilities within healthcare supply chains. This trend is not only a significant concern but also a critical opportunity for innovation. The healthcare industry must not only address immediate threats but also anticipate future challenges. This involves integrating cybersecurity into every aspect of our supply chain operations, from the development of advanced detection technologies to creating resilient supply chains. The fight against cybersecurity vulnerabilities requires a culture of awareness and responsibility. Together, we can build a more secure, resilient, and sustainable healthcare ecosystem! #cybersecurity #privacy #security #pharmaceuticals

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"How do we structure and strategize to bring successful products to market within the complexity that is oncology access? How much will the health system and payer access management change? What can manufacturers do to optimize success?   You are in luck as you can ask our experts at ASCO! They will be at Booth #35093 to answer any of your questions!    If you can't attend ASCO you can gain answers to these thought-provoking questions by tuning into their OnDemand webinar.    Watch now: https://lnkd.in/egRFWhxb"

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Situationships: What They Are and 5 Signs You’re in One : “Situationship” isn’t a word you’ll find in the dictionary, but it’s hard to avoid in popular culture. So, what is it exactly? According to psychologist Dr. Susan Albers, a situationship is a romantic relationship that hasn’t been formalized. “Situationships are characterized by a lack of obligation or exclusivity, but the real hallmark is a lack of clear boundaries or labels,” she explains. “There are elements of friendship and romance, but they exist without defining the relationship. So, essentially, you have many of the benefits of a traditional relationship without having to make a commitment.” As you can imagine, this kind of attachment has upsides and downsides. One the one hand, situationships may allow you to feel the sense of connection you’d experience in a standard-issue relationship and the independence that comes with being single. On the other hand, if you’re not clear on the nature of your involvement, it can’t progress. It’s difficult to maintain, emotionally. For further reading :

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Join Calyx’s #ClinicalTrial supply experts as they review simple methods to alleviate concerns about regulatory risks, enabling you to realize the many benefits of #MedicationPooling during #ClincialDevelopment. Attend the webinar. https://lnkd.in/eG3usXss #IRT #RTSM #TrialSupplyManagement #ChooseCalyx Malcolm Morrissey Steve Siron

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Sunshine, Strategy and (competitive) Solutions! Heading down to South San Francisco and the Bay Area soon! While virtual meetings are great <cough> Teams, Zoom, and Meets </cough>, INOVIS is all about real-life connections too. DM or email me if you're ready to connect...for coffee (or mimosas, no judgment) and chat about all things competitive intelligence (CI) - or anything else on your mind! #competitiveintelligence #strategicplanning #BayAreaConnect PS. Our capabilities and solutions have been growing from strength to strength! Let's chat about how INOVIS can help you stay ahead of the curve. PPS. Seen my latest book on CI? Its got all you need to know to level up in the competitive insights world!

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Implications of PBMs including their own biosimilars on formularies CVS Caremark and Express Scripps are including their own biosimilars on their formularies, while also excluding others' biosimilars. This has strategic implications impacting various industry participants and patients. #biotech #biotechnology #biopharma #pharmaceuticalindustry #R&D #research & development #innovation #life cycle management #investment #VC #Venturecapital #capitalmarkets #privateequity #financing #IRA #Inflation Reduction Act #FTC #Orange Book #Price #Market Access

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Check out our latest article by Evan Hansberry that discusses reasons why biotechnology and pharmaceutical companies should consider establishing their Safety function earlier in the drug development process. Read the full article on our website: https://ow.ly/CaU550SohfA #drugsafety #pharmacovigilance #biotechnology #pharmaceuticals #prestigescientific

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I have recently been brushing off programming skills to build small, personal LLM applications. As the article demonstrates, there is nothing like hands-on experience to really learn anything, including AI. https://lnkd.in/e5E4w5K8

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Life sciences organizations all generate significant #data that can and should be leveraged to empower better patient outcomes, further exploratory research, and more agile science. Explore the value of R&D data #accessibility here: https://lnkd.in/eCfJtkbU

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It's been an enlightening 12 weeks exploring Customer Lifetime Value (CLV), online/offline customer interaction, and AI applications. Excited to further explore real-world applications and drive business growth. #CLV #AI #BusinessGrowth

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