Anna Richards

Don’t miss this new feature by PCSIG focused on supporting the incorporation of patient-centric sampling into clinical trials. Currently includes: 📃 Report: Proceedings from the PCSIG Workshop on Incorporating Patient-Centric Sampling into Multicentre Clinical Trials ☑️ Protocol Template Text: Incorporating Patient-Centric Sampling in Clinical Trials ☑️ Lab Manual Template Text: Incorporating Patient-Centric Sampling in Clinical Trials PCSIG will be updating this page with more content over the upcoming months in line with its initiatives, and would welcome any thoughts and suggestions ([email protected]). #patientcentricsampling #clinicaltrials #pcs #decentralizedclinicaltrials

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EU-CTR Transition At Armah Consultants we can help you navigate the challenges of updating your documents in order to align them with the EU-CTR 536/2014 regulations. Contact us at [email protected]. for further information on how we can help 🌟 #ClinicalResearch #RegulatoryCompliance #PharmaceuticalIndustry #TeamSupport

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A robust clinical outcome assessment strategy that meets regulatory standards and resonates with patients and stakeholders helps ensure the accuracy, reliability, and relevance of all assessments conducted within the clinical trial. Discover all the factors to consider when developing a COA strategy in our latest blog https://ow.ly/b5SW50U4nFn #ClincialTrials #ClinicalResearch #ClinicalOutcomeAssessments

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Great to see some JCER papers referenced in the first session of today’s ISPOR RWE Summit (#ISPORSummit). Links below for anyone interested in reading more! #OpenAccess #RWE #RWD MEDICAL UNIVERSITY - SOFIA, Aetion, Ashley Jaksa Using real-world evidence in healthcare from Western to Central and Eastern Europe: a review of existing barriers 🔗https://lnkd.in/eGc7Z_6C Guidance on using real-world evidence from Western Europe in Central and Eastern European health policy decision making 🔗https://lnkd.in/eigCpH8h Use of transportability methods for real-world evidence generation: a review of current applications 🔗 https://lnkd.in/e5WTqerb

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Read about the essential steps and considerations for exporting clinical trial data in the Study Data Tabulation Model (SDTM) format from an Electronic Data Capture (EDC) system here: https://hubs.li/Q02ySrvB0 #CTMS #eTMF #EDC #RTSM #Safety #PV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials #SDTM

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We were delighted to have Ian Hamilton and John M. present to PIPA - Pharmaceutical Information and Pharmacovigilance Association members, with some fascinating insights on user journeys on emc, and search trends from HCPs looking up SRDs (Scientific Response Documents). Here's a snapshot of the insights shared: ⤷ Peak times for HCPs looking at medicines information on emc - 10am🕙 and 2pm🕑 ⤷ In 2024 so far, the most frequently viewed medicine information by HCPs on emc includes generic antibiotic (broad-spectrum), and branded generic antibiotic (urinary tract) 💊💉 ⤷ Top search themes for SRD searches included 'storage and stability' and 'dosing' 🔍 To learn more about SRDs and what insights Pharma can gain from this service, download the award-winning poster: https://bit.ly/3WGXJhl #pharma #healthcareoutcomes #medicinesinformation #HCPengagement

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Important EUDR Updates - First and foremost, the proposed 12 month delay to EUDR has been CONFIRMED! These are the headlines, but if you want more information or help implementing EUDR, contact our dedicated EUDR Helpdesk today - [email protected] and make sure you're subscribed to BPIF emails. #bpif #environment #sustainability #print #printingindustry #eudr #eudeforestationregulations #newsflash #packaging

📢 As the European Union Medical Device Regulation (EU MDR) takes full effect, medical device manufacturers must meet stringent regulatory requirements to ensure patient safety and achieve CE marking. At My Language Connection, we understand the importance of high-quality translations for compliance under the EU MDR. So much so that we have released our latest blog ‘Medical Device Translations - the EU MDR Perspective.’ Contact me today to learn more about our specialised translation services for medical devices and how we can help you achieve compliance and market entry. #MedicalDeviceRegulation #CEMarking #TranslationServices

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Regulatory update 🔔: NHS National Contract Value Review (NCVR) will be updated to incorporate clinical trials of #ATMPs. ➡️ https://ow.ly/mp2e50U07j8 The NCVR is a standardised, national approach to costing for commercial contract research. To support this change, a new model clinical trial agreement for ATMPs and a new clinical research organisation (CRO) model clinical trial agreement for ATMPs will be introduced. Learn more in the newly released October edition of our monthly Regulatory Round-up ☝️ #CellTherapy #GeneTherapy #AdvancedTherapies

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If you write about medicines for a UK audience - take note of clause 26 (page 47)! The ABPI Code also "sets standards relating to the provision of information to patients and the public as well as relationships with patient organisations." #MedicalWriting #MedicalWriter

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🩺 Hiring professional #MedicalTranslation services in the life sciences sector may seem like the obvious choice—it’s a scientific field where many aspects of the process are at stake, whether compliance or people’s safety. 🌎 But there’s more to consider besides what cannot be compromised. The #LifeSciences sector is an ever-growing field, and there’s international room for companies to broaden their commercial horizons. Learn more in our blog: https://lnkd.in/dp_VB4wG

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Outsourcing QC tasks in regulatory and medical writing gives sponsors a competitive edge, as managing QC activities in-house can stretch resources thin! This diverts valuable time from medical writers who could be focusing on more complex tasks. Our latest blog article taps into several key advantages, including: 🔶 Cost-effectiveness and lower overhead costs 🔶 Scalability and flexibility during peak periods 🔶 Faster turnaround times 🔶 Domain expertise and knowledge of regulatory guidelines Minimize the risk of non-compliance and costly delays. Read our latest article for details: https://hubs.li/Q02Wg5Xz0 #QualityControl #MedicalWriting #Outsourcing #PharmaceuticalIndustry

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The Study Marketplace quickly grows your study pipeline by enabling: -Study opportunity assessment in under 2 minutes -Efficient applications -Easy document review -Organization and collaboration Download our one pager now for details: https://ow.ly/2boT50S0Teo #clinicaltrials #clinicalresearch #patientrecruitment

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New on the Blog: https://ow.ly/peJk50SQbep Although there are benefits to foreign clinical trials (FCTs), there are some challenges. We invite you to read about insurance considerations for FCTs and the path forward. #clinicaltrials #foreignclinicaltrials #clinicaltrialliability

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The EMA Annual Report of the Good Clinical Practice (GCP) Inspectors This report contains data from inspections conducted in 2023. It offers valuable insights for learning, understanding how inspectors think, and mitigating risks in your clinical trials. https://lnkd.in/ddtMVuRc #audit #GCP #EMA #Inspection #clinicaltrials

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The success of your Phase 1 study depends on your trial design. You need a meticulous blueprint to gather the right preliminary data on safety, pharmacokinetics, and pharmacodynamics. Find out how our medical writers help sponsors achieve this in our latest blog: https://hubs.li/Q02PC3Kw0 #pharmacokinetics #phase1 #trialdesign #medicalwriters

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Ironically enough, we're back this week to talk about DISAPPEARING CYTOMETRISTS! Cause... y'know, it's been a few weeks. Plumb the depths of Clinical and Laboratory Standards Institute (CLSI) H62 to learn how #qualitysystems and #qualitymanagement can help develop lab #leadership and address the scarcity of #flowcytometry expertise across #academia and #industry by improving lab #culture, #retention, and overall #happiness. https://lnkd.in/eY9PJHWd

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We recently visited the African Union Development Agency-NEPAD, South African Health Products Regulatory Authority, Zambia Medicines Regulatory Authority (ZAMRA) and Food and Drugs Authority,Ghana to discuss regulatory strengthening at regional and national levels. It was great to share with these agencies how CIRS tools can support them with their regulatory strengthening efforts, including working towards WHO Global Benchmarking Tool assessment. Thank you all for having us! 😊 Read more about CIRS tools >> https://lnkd.in/eVyzCAex #RegulatoryScience #Africa #pharmaceuticals #RegulatoryAffairs

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