ClinicalMind’s Post

Are you struggling to effectively communicate clinical trial results? That's why we created TrialSummaries[.]com to make it easy for you to share plain language summaries with the people who matter most. With TrialSummaries[.]com: • Easily share plain language summaries with patients • Save time by sharing summaries in a central location instead of or in addition to distributing from study sites • Ensure patients find summaries effortlessly • Demonstrate commitment to transparency and patient empowerment Let's elevate trial transparency. Learn more: https://ow.ly/AePJ50RCeG6 #PlainLanguageSummaries #ClinicalTrials #RAPSWebinar #ClinicalTrialResults #HealthLiteracy

Have you heard of a Plain Language Summary of a Publication (PLSP)? PLSPs are a standalone, peer-reviewed summary of the original publication. Here at Ardelyx Medical, we are using PLSPs to communicate complex information and to strengthen the transparency, inclusivity, and accessibility of scientific research. Stay tuned for updates on some of our recently published PLSPs! #ArdelyxProud

𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐭 𝐩𝐫𝐞𝐬𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧 𝐛𝐲 Pras Pathmanathan 𝐨𝐧 𝐭𝐡𝐞 𝐅𝐃𝐀'𝐬 𝐥𝐚𝐭𝐞𝐬𝐭 𝐅𝐢𝐧𝐚𝐥 𝐆𝐮𝐢𝐝𝐚𝐧𝐜𝐞 𝐟𝐨𝐫 𝐄𝐯𝐚𝐥𝐮𝐚𝐭𝐢𝐧𝐠 𝐭𝐡𝐞 𝐂𝐫𝐞𝐝𝐢𝐛𝐢𝐥𝐢𝐭𝐲 𝐨𝐟 𝐂𝐨𝐦𝐩𝐮𝐭𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐌𝐨𝐝𝐞𝐥𝐬 💻💊 We found the section on "leveraging real-world data for validating computational models" particularly compelling. At InSilicoMinds, this is an area we are deeply #passionate about, and we are eager to observe the influence of the FDA's new guidance on the advancement of new #medicaldevices and #pharmaceuticals. 💭 What are your thoughts on the FDA's recent guidance? How do you anticipate it will impact the industry? We welcome your input in the comments section below on this matter. FDA #CDRH #computationalmodels #modeling #simulation #insilico #goodsimulationpractice #regulatoryscience InSilicoTrials

"Decoding Clinical Trial Synopsis: Bridging Precision and Accessibility" Navigating the intricacies of clinical trial synopsis demands a nuanced understanding of specialized terminology and statistical intricacies, making it a formidable task for the uninitiated. Fortunately, our medical experts are ready to provide the support you need. With a profound grasp of the complexities inherent in clinical trial documentation, our medical experts ensure that each synopsis is not merely a compilation of data but a comprehensible roadmap through the scientific narrative. Would you like more information about our language services? contact us: orders@pharmamed-eg.com #clinicaltrials #medicaltranslation #languageexperts #clinicalresearch #clinicaltrials #pharmamed

Another 🔥 blog from our Global Head of Life Sciences, Clio Schils. This time, she dives into #PlainLanguageSummaries (PLS). She states: "Under the CTR, sponsors must submit PLS typically within 12 months following the conclusion of a clinical trial....the following best practices for creating and submitting a PLS include: at the start of the trial: Plan for the PLS from the beginning of the trial by outlining key messages and ensuring data collection methods support clear, concise communication. during the trial: Regularly update the PLS draft to reflect ongoing findings, ensuring it is ready for finalization promptly after the trial concludes. end of the trial: Finalize the PLS once the trial is complete and all data have been analyzed. Submit the summary to the relevant regulatory authorities alongside the clinical trial report. post-submission: Ensure that the PLS are accessible to the public through appropriate platforms, such as the regulatory databases, company websites, or patient advocacy group portals. 🔔 Do you have questions about how to optimize your PLS program? If so, reach out to CQ fluency to learn more. #clinical #translation #localization #accessibility

RECORDINGS POSTED for the Feb. and Mar. 2024 DIA RIM Intelligent Automation Team meetings. Both sessions featured example #generativeai capabilities: Feb. was Ari Caroline from Weave sharing an example of using #genai to help medical writers author submission documents and March was Jyotiska Biswas from ThinkTrends sharing an example of using #genai to search and summarize health authority requirements and guidances. DIA members can find the recording link in the Reg. Affairs Community site at the link below and under Library – RIM / Intelligent Automation folder. https://lnkd.in/eK67YNtH #diarim #intelligentautomation #rim #regulatory #regaffairs #regintel #ai #lifescience #pharma

🙍♂️ 🙍♀️ 💻 Patient-specific models (PSMs) are computational models that are personalized to individual patients using clinical data, typically medical images. PSMs are closely related to Digital Twins. ✅ We've just released an OSEL Regulatory Science Tool (RST) that provides a workflow for evaluating patient-specific models within the framework of the recent FDA Model Credibility Guidance! I hope it's useful, in regulatory submissions or by anyone else evaluating a PSM. https://lnkd.in/gvUiBGRG 👏 Thanks to everyone who contributed, including Kenneth Aycock, Brent Craven, and the authors of the paper it is based on, Suran Galappaththige, Steven Niederer, Richard A. Gray, PhD and Caroline Mendonca Costa Also, as our Office Director Ed Margerrison recently posted, check out the full RST Catalog - it'll be worth it. More model credibility RSTs to come!

Our very own Clio Schils is at it again with this insightful blog post about "the power of plain language summaries". As she states "Imagine standing at the crossroads of hope and uncertainty, armed with a diagnosis but left in the dark by a wall of complex medical jargon. A grandmother with a rare condition, eager to understand her options; a young parent, desperate for answers to help their child. For them, clinical research holds the promise of life-changing treatments—but the language of that research often feels like a foreign code." That's where CQ fluency comes in. Contact us with any questions about how we can support your PLS program. #translation #localization #plainlanguagesummaries #CTR #CTIS #ClinicalTrialsInformationSystem #ClinicalTrialsRegulation #clinical

Literature Search for EU MDR: How Reproducible is the Search in PubMed? Over the past year, I've been closely monitoring the number of results in PubMed based on the search date using the search term compression. This broad term was intentionally chosen to better observe the dynamic changes in the number of results. The search period was from June 26th to July 2nd, 2023. It's fascinating to see how the number of results rapidly increased at first, and then grew more slowly over the course of almost a year. What's even more interesting is that at the end of the year, the number of results was nearly twice as high as the day immediately following the end of that period. This shows that the number of results not only depends on the selected search terms and filters, but also on the time elapsed since the end of the search period. #systematicliteraturesearch #literaturesearch #systematicreview #medicalwriting #mdr #clinicalevaluation #medicaldevices #pubmed

For HEOR/RWE professionals.. All Poland HTA (AOTMiT) related guidance and method documents are available at this link. AOTMiT Library The documents are in Polish language and needs translation. https://lnkd.in/drqTKsrb #marketaccess #hta #pharmaceuticalindustry #healtheconomics #realworldevidence #systematicreview #metaanalysis #modelingandsimulation #modeling