NSW Medical Research’s Post

Proud to achieve my Good Clinical Practice certification with NIDA Clinical Trials Network! 🌟 This milestone underscores a commitment to ethical research, participant safety, and integrity in clinical trials. Every protocol, every participant, every data point matters. Here's to advancing research responsibly! #EthicalResearch #ClinicalExcellence #GoodClinicalPractice #LifelongLearning

How can we effectively integrate findings from clinical trials into everyday clinical practice? 1. Society’s goals for medicine require integration of the clinical trials and health care delivery enterprises to ensure the efficient and rapid generation and dissemination of knowledge on what care works and how it should be organized and delivered 2. These 2 enterprises operate as a house divided, to the detriment of both and to the detriment of society. Repairing the division requires changes in ethical and regulatory oversight, study design, data infrastructure, and incentive structures for stakeholders in both enterprises 3. The gulf between the care available and the care that could be available has never been wider. Solutions exist, but have not been prioritized. In a series of upcoming articles, we will explore each of these issues in more detail and outline specific recommendations https://lnkd.in/e6r5uwKS

HELLO CONNECTION, GREETING OF THE DAY 😊 I am so happy to announce that. I have successfully completed the certification of "Good Clinical Practices " conducted by NIDA Clinical Trails Network And thus course give me the immense and improve knowledge about how the Clinical studies or Clinical trails is to be taking place. #NIDA #clinicalTrials #Clinicalresearch

Just completed a webinar on "Clinical Masterclass series 2023 - The Clinical Evaluation Report Part 2" from BSI #medicaldevices #regulatoryaffairs #clinicalevaluationreport

🧠 Crafting a perfect clinical trial protocol is no small task! 💡 A well-written protocol is the foundation of clinical research, ensuring clarity, safety, and compliance. 🎯 Covers key aspects like objectives, design, and data analysis, ensuring high-quality, reliable results. 🚀 A strong protocol minimizes amendments, reduces delays, and ensures patient safety. Where do you start? 🤔 📝 Understand the importance of each component—from study objectives to ethical considerations, every detail matters. ↓ https://lnkd.in/gUyXPvSw ✨ Ready to optimize your clinical trial? Let’s discuss how Credevo can support your protocol writing and streamline your research process. 🌍🧪 #ClinicalTrials #ProtocolWriting

🔍 Exciting News Alert! 📢 Following the latest MDCG CIE meeting, a new guidance on the content of clinical investigation plan (=protocol) has just been released, along with an informative appendix. Dive into the details here: https://lnkd.in/eJhUU7z9 This comprehensive guidance promises to streamline the process of requesting authorization for clinical investigation by outlining clear expectations. Stay tuned for another upcoming guidance focusing on the content of the investigator brochure! 📑 #ClinicalResearch #MedicalDevices #RegulatoryUpdates

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I´d like to share with you my new course certificate about the Introduction to Good Clinical Practice by Norvartis where I learned to explore the clinical trial process, the basics of good clinical practice, and the history of regulatory frameworks for medical treatment and testing. Verify at: https://lnkd.in/guJuhSKj #ClinicalResearch #GoodClinicaPractice #Learning #ClinicalTrialbasics #RegulatoryFrameworks

There are frequently omissions in #medtech sponsors’ clinical investigation plans which can delay competent authority approval of investigations. New guidance, in the form of MDCG 2024-3, was much needed. But are other stakeholders, just like Maria E. Donawa, M.D., finding that there are challenges in understanding how this latest document links with the #EUMDR and international standard ISO 14155:2020?  https://bit.ly/4avU49Y

🎉 Excited to share that I’ve completed the "Clinical Trials" Course from the NIDA Clinical Trials Network! 📚 This course has equipped me with in-depth knowledge on critical aspects of Clinical Research including understanding of Institutional Review Boards, Informed Consent, Confidentiality, Participant Safety, Quality Assurance, and much more. I’m eager to leverage these insights to enhance research protocols and contribute to advancing clinical trials. 🚀🔬 #ClinicalTrials #ResearchEthics #ProfessionalDevelopment #ClinicalResearch #LifelongLearning.