Andrew Mackinnon

Oncology clinical research sites often encounter intricate challenges in budgeting for complex trials. Join us to review common billable items often overlooked in budgeting processes through the SCRS Site Invoiceables Toolkit. Gain practical knowledge to empower your site to navigate budget negotiations. Register here ⇢ https://lnkd.in/d-reDKKD

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Of interest to anyone involved with clinical trials - interesting example of what Alexion are using in the patient centric approach to clinical trials. Cezary Statuch at Alexion points out the value of using direct feedback from patients to improve the trial. We've seen similar improvements in trials from a decrease in the drop-out rate to a higher level of patient engagement reducing protocol deviations. https://lnkd.in/eCaJ-CnG

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Gene therapy is in focus in our latest Regulatory Navigator blog from our cell and gene regulatory experts, Rajiv Gangurde and Steve Winitsky. They discuss how AAV manufacturing can cause bottlenecks, with cost recovery for overall development driving pricing. Read more now.

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You can become a high-performing Clinical Trial Manager faster than you might think. You’ve probably seen colleagues accelerate quickly from CTA to CTM and beyond, and you might wonder how they did it. Why them and not you? Becoming a high-performing CTM not only benefits you to stand out in a crowd of over 68,000 CTMs on LinkedIn alone, but it also benefits your company. Benefits of being a high-performer for you: 🧠More career opportunities (promotions, raises, visibility from recruiters, unicorn job opportunities that are only offered to very capable CTMs) 🧠Strong professional network of industry professionals who respect your results and style 🧠Robust subject matter expertise that provides you with confidence in navigating challenges Benefits of you being a high-performer for your company: 🔎Complete trials faster, at a lower cost and with higher quality 🔍Retain you and other employees for longer which saves money and resources 🔍Establishes a strong work culture and helps employees to feel seen and valued A high-performing CTM doesn’t just get better results faster, but they FEEL great about how they move throughout their day. With ease, confidence, purpose, and focused on what matters. 📈If you’re ready to become a high-performing CTM that benefits both you and your company, join me for a FREE online master class on Monday, August 19th at 7:30pm EST. You will leave with actionable strategies for putting systems in place at work that will get you results same day and allow you to focus on what really moves the needle in your study and your career. Grab your FREE spot below ⬇️ https://lnkd.in/eSqtbq7s

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Great review from Lydia! Both remote and on-site monitoring have their benefits and challenges but the most important part of successful monitoring is your Clinical Research Associate! If you have good CRA all types of monitoring are working without issues. #remotemonitoring #CRA #clinicaltrials

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According to our 2024 CRA Impact Report, 81% of CRAs can identify issues with site documents earlier using remote monitoring, up from 75% in the last report. Early detection, faster resolutions. 🕵️‍♀️ ✅ 📥 Get the full report: https://bit.ly/3xo59LY

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The 2024 Impact of Site Enablement Platforms on CRAs report is live! 🎆 Discover how remote monitoring is revolutionizing clinical research with 73% of CRAs reporting accelerated site start-up and 81% reporting quicker document deliveries. 📥 Download the full report to learn more: https://bit.ly/3xo59LY #CRA #ClinicalResearch #SiteEnablement

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📹 In this part of her video interview with Applied Clinical Trials Magazine, Sonia Lwoff, director, clinical operations, Rho, offers her thoughts on key considerations that sponsors should be mindful of during the decision-making process with the timeline of a clinical trial

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The Clinical Research Industry - How has 2024 matched up to previous years? One question I have been asked consistently by my Clinical network over the past few months has been, "when will things get better?". It has been a difficult 12-18 months within the Life Sciences industry as a whole, although one area that has been affected more so than others, is the Clinical Research side. As businesses understandably shift their focus to commercialised assets, driving sales to recoup losses and mitigate a slow investment environment, those working before the point of approval/near-approval are feeling the turbulence, with both a lack of available resource and countless layoffs/restructurings. Over the past decade, we have seen (mostly) steady increases to the volume of clinical trials globally YoY: 2014: ~7,500 trials initiated 2015: ~24,000 trials initiated 2016: ~26,000 trials initiated 2017: ~27,500 trials initiated 2018: ~30,000 trials initiated 2019: ~31,000 trials initiated 2020: ~33,000 trials initiated 2021: ~37,000 trials initiated (peak year) 2022: ~35,000 trials initiated 2023: ~34,000 trials initiated 2024: ~16,000 trials initiated (projected by end of year) Although, post 2021, we have seen a steady decline, followed by a sharp drop this year. It is clear that 2024 in particular has been one of the toughest. So, when will things get better? When will companies start re-investing in their early-stage pipelines? The truth is, no one knows, and it certainly won't be an overnight solution. What is true, however, is that our industry is cyclical. Once sales start to bring in revenue, and organisations return to a more stable setting, there will be a need to re-focus efforts on R&D or risk falling behind to competitors. Essentially, we don't know when it will get better, just that it will eventually, and there are certainly some positive signs investment-wise to suggest this will be sooner rather than later. Interested to know my networks thoughts- do you think we've weathered the worst of the storm? or is there more to come? Data source: https://lnkd.in/eERrckwH #clinicalresearch #lifesciences #clinicaltrends #clinicaloperations #clinicaldevelopment

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All set for Society for Clinical Research Sites (SCRS) #scrs24 west conference. Be sure to stop any of the Advarra team for questions about our services, or to just swap story and catch up. #clinicalresearch

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The volume of clinical data has grown 183% over the last decade — impacting cycle times. 📈⏱️ For CROs already working under tight timelines, addressing the data chaos problem is imperative. Learn how elluminate can help 👇 The elluminate Clinical Data Cloud is a proven end-to-end platform that enables CROs to modernize trial processes, maximize efficiency and reduce cycle times. With elluminate, CROs can empower and engage clients with a single source of truth for clinical and operational data, facilitating streamlined data access for data management, clinical operations, medical monitoring and safety. Learn more about elluminate here: https://lnkd.in/e-mvhuAd #clinicaltrials #clinicaldata

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Calling all small and mid-sized clinical trial leaders 📢 Share your insights in our 5-10 minute anonymous survey with GlobalData Plc to help build a report on the state of the industry. Your input is essential to understanding the current landscape → https://lnkd.in/djx33_y9

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New Blog Alert! Here are 5 Tips for Clinical Trial Managers when planning for the First Site Activated milestone. https://lnkd.in/gYefDFCP If you are in Study Start-Up as a CTM, Associate CTM or Lead CRA, be sure to check the list to make sure you are not missing anything! What else do you consider when planning for First Site Activated? #clinicalresearch #clinicaltrials

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How does a regulation that's there to protect patients' rights affect Clinical Research Associates (CRA)? ☝️ One of the best things about belonging to a Community for CRAs is getting to learn from so many skilled and knowledgeable professionals from the industry. ✨ Benjamin Foley, Global Study Manager at AstraZeneca, recently posted a video explaining how clinical trial regulation impacts CRAs, your work, your responsibilities and your day-to-day. 👀 If you want to watch the full video and follow Benjamin's content, join us here: https://lnkd.in/e2XEyhgZ

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Looking for that next binge-worthy podcast? Three of Parexel's top thought leaders recently joined ACRO’s Good Clinical Podcast to cover trending topics in the clinical research ecosystem: 🌟 S2 Episode 1: "All Hands on Deck" for Empathetic Patient Centricity 🌟 Stacy Hurt 🌻 and Alicia C. Staley discuss turning patient centricity from “buzz word” into action. Hear their personal patient experiences and learn how the upstream patient voice can reduce burden on patients. 🤖 S2 Episode 2: AI in Clinical Research: Decoding Regulatory Expectations 🤖 Stephen Pyke and the FDA's Dr. Tala Fakhouri delve into AI advancements and implications for patients. Discover the FDA’s evidentiary standards for AI, the importance of methodological transparency and how AI can streamline drug development. 🚗 S2 Episode 5: RBQM: Moving Beyond a Belt and Suspenders Approach to Data Quality 🚗 Cris McDavid weighs in on ACRO’s annual RBQM landscape survey findings. Get a sneak peek into five years of RBM/RBQM adoption data and what it means for the future of clinical research. 🎧 Leave a comment below to share your thoughts on these hot topics. Happy listening! 🎙️

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With up to 40% of drugs on the market exhibiting poor solubility or bioavailability, it is still one of the biggest hurdles in #DrugDevelopment. Veranova's VP and General Manager, Cambridge, Craig Grant, recently spoke to International Pharmaceutical Industry Journal to discuss innovative solutions and strategies that can be harnessed to advance poorly soluble drugs. Read the full interview now to learn more about the power of solid form and particle engineering during early development: https://lnkd.in/egUavXP5

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🌟💬 Xtalks Spotlight: In this exclusive interview with Alison O'Neill, Chief Operating Officer at YPrime, to explore the power of collaboration in clinical trials. With over 35 years of experience in patient-centric trials, Alison shares how a partnership mindset can drive significant value for sponsors, leading to smoother project deliveries and better patient outcomes. ⏩ Watch + read the Spotlight with Alison O'Neill here: https://buff.ly/4dOa9cj #ClinicalTrials #Compliance #ClinicalResearch #ClinicalOperations #ClinicalDevelopment #QualityManagement #QualityCompliance #XtalksSpotlight

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