James Rucki

CROs play a vital role in clinical data management, and effective oversight is essential to ensure the quality, integrity, and compliance of trial data. In our latest blog, Debra Anderson shares how sponsors can optimize CRO partnerships by addressing key challenges to maximize the success of clinical trials. Read it now: https://lnkd.in/eePDgPKa

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Unlock the Power of a Strategic CRO at Every Stage of Your MedTech Clinical Studies! 🚀 Navigating MedTech clinical studies demands a strategic approach. Here’s how a strategic CRO excels at each critical stage compared to an average CRO: 🌟 Superior Site Selection Average CRO: Basic criteria, limited performance metrics. Our Strategic CRO: Data-driven insights for optimal site choice, enhancing enrollment and data quality. 🚀 Effective Site Recruitment Average CRO: Conventional methods, recruitment challenges. Our Strategic CRO: Innovative strategies for swift site enrollment, ensuring timelines are met. 📊 Expert IRB Management Average CRO: Standard approach, compliance risks. Our Strategic CRO: Ensuring compliance and timely approvals, minimizing delays and maintaining study integrity. 📝 Custom Protocol Development Average CRO: One-size-fits-all, compromised integrity. Our Strategic CRO: Precise, effective, regulatory-compliant protocols tailored to study needs. 📞 Robust Site Communication Average CRO: Basic communication, potential disruptions. Our Strategic CRO: Clear and consistent communication for smooth operations, resolving issues promptly. ✍️ Professional Manuscript Development Average CRO: Limited support, lower publication quality. Our Strategic CRO: Expert writing, editing, and submission for impactful publications, enhancing study visibility. 📆 Let's explore a potential clinical study! Use the following link to easily schedule a brief call with our VP of Client Relations, Fernanda Nusbaum https://zurl.co/YY8T 📰 TTi's newsletter: Sign up now! More insightful content coming this July! https://lnkd.in/dMPbm9-Y #MedTech #ClinicalTrials #CRO #StrategicPartner #ClinicalResearch #SiteSelection #SiteRecruitment #IRBManagement #ProtocolDevelopment #SiteCommunication #ManuscriptDevelopment #HealthcareInnovation #MedicalDevices #Clinical #Research #MedDevice

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Emerging and mid-cap biopharma companies often face tight budgets, making it crucial to maximize value. Outsourcing field services to a commercialization partner can help maximize resources while competing with more established companies. Discover the five key qualities to look for in a field services partner: https://ow.ly/egv550T8Fmu

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As a medical device sponsor, you should start by asking the right questions. In this fact sheet, we uncover the key questions to ask CRO providers when outsourcing – from assessing a CRO’s track record and therapeutic expertise, to understanding their global reach and communication strategies. https://bit.ly/3zicBcD #MedicalDevice

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Radha Patel, PharmD, BCPS, BCIDP: "Having used everything from manual calculations with TI-83s to Bayesian dosing tools like InsightRX, I can confidently say that not all solutions were built to grow with your organization." Questions to consider: 1) How are the vancomycin models in your software being updated? 2) How are you validating dosing accuracy for patients excluded from reference model data? See how our Data Scientists looked to answer these types of questions: Choosing the right model for your patient: An introduction to InsightRX Gemini℠ https://hubs.ly/Q02RP6QG0

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🚨 Major CRM Shift on the Horizon within the Life Science Industry 🚨 With Veeva Systems announcing their split from Salesforce (SFDC), over 90% of life sciences companies are expected to transition their CRM systems within the next 3-5 years. This significant change will have wide-reaching impact across the industry. 🌟 To help you navigate this evolving landscape, we're hosting a two-part webinar series designed to prepare you for the challenges and opportunities ahead. Whether you're staying with Veeva, Salesforce, or considering other CRM options, this series is a must-attend! In this two-part webinar series, we’ll cover: ✅ Anticipated short-term and long-term operational changes ✅ Key implications for current CRM users ✅ Strategies to effectively manage these transitions ✅ How QPharma can support you through every step of the process 📅 Date & Time: Part 1 - October 24, 2024 - 1:00pm ET 🔗 Register Now to secure your spot at https://cvent.me/P4yeaV! Don’t miss out on this critical conversation—prepare your business for the future of CRM in life sciences! #LifeSciences #CRM #Veeva #Salesforce #Webinar #DigitalTransformation #QPharma #Innovation

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How aligned is your precision oncology growth strategy with the evolving needs of your customers?🧬 Delve into groundbreaking opportunities in precision oncology, driven by industry shifts and innovations.📈 🔗Click here position your organization at the forefront of precision oncology innovation! https://hubs.la/Q02BRl970 #PrecisionOncology #GrowthStrategy #HealthcareInnovation #Oncology #MedicalResearch #HealthcareIndustry Sherin George | Robin Joffe | Nimisha Iyer | Nitin Naik | Unmesh Lal | Shylesh Narayanan | Tamer Abu Elhassan | Mark D. | Abdulaziz Jalab | Arun Stanly | Hani Al Sayed

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Another great session led by our CEO, Ander Tallett, on the Top 10 Use Cases for Smartsheet in Biopharma. If you're at ENGAGE, come stop by booth 501 to learn more, or, comment "ENGAGE" and we'll send over the deck! #ENGAGE2024 #SMARTSHEET #SPONSOR

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Want to know how the FDA’s Project Optimus is reshaping oncology drug development? Check out our blog post for real-world case studies and industry impacts! https://hubs.ly/Q02CJ5vr0 #Oncology #DrugDevelopment #ProjectOptimus

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Faster FDA approval through Real-World Evidence? Absolutely! FDA is incorporating RWE into regulatory decisions, helping pharmaceutical companies streamline the approval process. Learn how RWE can benefit your product's journey. #FDAApproval #RWE #CommercialStrategy #FacetLifeSciences https://hubs.ly/Q02Vb54y0

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📉 Big Shift in Clinical Trials: Oncology’s stronghold on clinical trial starts has taken a significant dip over the past year. Non-oncology trials now account for 43% of all clinical trial starts in Q1 2024, up from 32% in Q1 2023 📅. 🚀 This shift underscores the growing impact of gene therapy 🧬, which is expanding to address a wider array of unmet needs. 🔍 Question for you: With gene therapy making strides, where should we focus our efforts next in clinical trials? 💡 #ClinicalTrials #GeneTherapy #HealthcareInnovation #Citeline #ClinicalDevelopment

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The Market Access strategy is a critical component for demonstrating future value of an asset to investors, potential partners and other stakeholders. Thanks to Joep Muijrers from Gilde Healthcare for sharing why market access is important from an investor perspective and follow the link to hear more. #biotech #earlycommercial #marketaccess

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Read the article: https://ow.ly/zuXm50SkgRw Accelerated approvals, staying abreast of rapid changes in data and navigating regulatory intricacies further complicate the commercialization of #oncology therapies. Consequently, challenges like infrastructure, risk spending, and communicating value arise. Learn about considerations and innovative approaches to enhance your commercialization strategies.

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Is it time to #implement a marketing material review platform, like Veeva #PromoMats, within your life sciences organization? Here are 4 considerations that #marketing ops leaders should keep in mind to enable a compliant review process for promotional and non-promotional materials: https://hubs.ly/Q02wq1gK0

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Is it time to #implement a marketing material review platform, like Veeva #PromoMats, within your life sciences organization? Here are 4 considerations that #marketing ops leaders should keep in mind to enable a compliant review process for promotional and non-promotional materials: https://hubs.ly/Q02Nqngk0

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Innovation starts here. For sponsors looking to make a real impact, #GeneTherapies are promising. Pharmacokinetic analysis can shape dosing strategies and provide input into drug safety & efficacy – learn more: https://bit.ly/3zDqPRs #CGT #GeneTherapy #PKassessments

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Setting realistic expectations for how payer coverage is likely to build over time is critical for pharma companies. https://ow.ly/UAB250SjbFW In this case study, learn how one small oncology biopharma used MMIT’s coverage uptake analysis for new drugs to prepare for the launch of its therapy. #FDA #Oncology #Biopharma #BiopharmaInsights #MarketAccess

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Don't miss Informa's Global Clinical Trials Digital Week! This FREE, virtual event is sure to deliver! Join Endpoint's VP, Product Strategy, Jeff Rubesin as he joins a panel of industry colleagues to discuss: "The Future of IRT Integration," on May 15 at 11 am EDT! Learn how proactive #IRT can optimize clinical trials by streamlining processes, reducing costs, and simplifying site experiences. In this panel, the following will be discussed:  **What does the future for sites and patients with IRT integration look like?  **Managing clinical supply chain strategies through IRT portals   **Navigating regulatory issues with IRT integration   This event is FREE - register here: https://ow.ly/SY8Z50RztOQ

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☕ #Boston, grab you favorite Dunkin’ coffee and join us at the Precision in Clinical Trials Summit May 6 & 7! Stop by Booth #11 to meet the #IDDI experts Tara Kervin & Kalyn D. to discuss how IDDI’s solutions can assist your most pressing clinical trial challenges. 📈 Schedule a meeting today: https://lnkd.in/efjcJffp #PCTSummit #biometricscro #clinicaltrials #biostatistics #datamanagement #lifesciences #trialdesign

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