Becca Schutt

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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Payer policies can be unpredictable, but your biosimilar strategy doesn’t have to be. Amplify Rx's software streamlines the authorization process, ensuring that the right biosimilar is chosen every time. #HealthcareStrategy #HealthcareInnovation #Biosimilars #AmplifyRx

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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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When choosing a CRO, you'll likely look at a variety of factors, from budget to culture. Size is one element to take into account: here are three reasons why choosing a smaller CRO can boost your clinical trial. https://buff.ly/4caRzup #clinicaltrials #CRO #clinicalresearch #consultants

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When launching a new product in the life sciences industry, you need more than great data—you need a compelling story. A Value Dossier aligns stakeholders and demonstrates the real-world benefits of your innovation. Learn how it supports clinical, economic, and patient-centered outcomes. https://hubs.la/Q02ZJKm30 #ValueDossier #LifeSciencesConsulting #CommercializationServices #FacetLifeSciences

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If you’re thinking about the fact that the FDA is requiring your study demographic to match the patient demographic of your indication (which you should), #RWD is required. Reach out to discuss the ways you can build a study that addresses both the concerns of the FDA, recruitment capabilities, and public health concerns

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Alignment across clinical and payer perspectives can be challenging. Read how a top #pharma company achieved faster timelines and deeper insights by bringing payer feedback into trial design in just 90 seconds: https://lnkd.in/efrAAFUe

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Based on the projected evolution of real-world evidence and recent regulatory guidance, it will be essential for life sciences companies to secure high-quality, integrated, and diverse real-world data with the ability to query the source. Learn more about #rwe and other #HEOR trends in this thought leadership article by Carelon Research Principal Scientist, Michael Grabner: https://ow.ly/xEvW50S8vrC.

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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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In our latest blog, "Remote vs. Onsite: Tracking Regulatory Affairs Hiring Trends in Biopharma," we dive deep into two years of data to explore how worksite preferences have shifted in the Regulatory Affairs sector. #weknowregulatory #regulatoryaffairs

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📣 ICYMI📣 July's Resource Roundup includes: 📖 How to set up your CDMS/EDC to overcome staffing challenges and grow with you 📊 What other small biopharma orgs and CROs think about the latest eClinical trends 🏥 Meeting the regulatory push for Real-Time Oncology Review (RTOR) while executing mid-study changes Learn more here: https://bit.ly/3W2xbVT #EDC #CDMS #Oncology #Biotech #CRO #DataQuality #ClinicalDataManagement #ClinicalTrials

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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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Did you know? Science 37 has been pioneering remote clinical trials for a decade (since 2014)! In this video, listen to Chief Medical Officer Dr. Jonathan Cotliar discuss the evolving regulatory landscape and how our Virtual Site model aligns with the latest FDA Draft Guidance. Watch the full "10 Things You Didn't Know About a Virtual Site" webinar recording here: https://lnkd.in/eU_vXT8J #clinicalresearch #clinicaltrials #virtualtrials

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How many times have you heard, “It’s all about the data?” Clinical trials are more than data points—they’re about asking the right questions to uncover the best paths forward. At #CDISC, Natalie Walker Freeland, Maddie Hays, Tiffany Bainter, and Dave Scocca shared how standardized data approaches are driving better insights across clinical and regulatory landscapes (check back next week and we’ll share!).   At Rho, we’re not just here to navigate regulations or crunch numbers. We’re here to ask better questions and push the boundaries of possibility for our clients and their patients. Are you ready for new possibilities? Message us.

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Tired of duplicate patient alerts, limited geographic reach, and messy lab data hindering your HCP engagement efforts? Our latest blog post delves into these common challenges and explores how a strategic approach to patient alerts can transform your strategy: * Optimize resource allocation by eliminating redundant alerts * Expand your reach to engage HCPs nationwide * Ensure data accuracy for targeted, effective communication * Improve timing to influence treatment decisions at critical moments There's a better way to engage HCPs and drive your brand's success. Read more here: https://bit.ly/3WtalGV #HCPengagement #pharmaceuticalmarketing #patientalerts #datadrivenmarketing #PrognosAlerts

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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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We're excited to be heading to SCIP Intellicon in Nashville, April 22-25! Who else will be there?   You won't want to miss Anshuman Kelkar's session, in which he will share how he's leveraging AI to transform competitive intelligence at Bayer. As the pace of change continues to accelerate, innovative technologies like generative AI are becoming essential tools for staying ahead of the curve.   We can't wait to connect 🤝 with other CI professionals and learn about the latest trends and best practices. Hope to see you there!   #SCIP #IntelliCon #CompetitiveIntelligence #MarketIntelligence #GenAI Erin Pearson Gabriel Keeler Coleen Hobaugh Ambika Kashyap

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FDA’s new #PDURS framework could allow pharma companies to develop and promote practice-improving software more smoothly than ever before. In a pharmaphorum webinar, brought to you by EVERSANA, experts Marty Culjat of EVERSANA and Edward Cox of Pfizer dug in to the upcoming new paradigm.

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