Vijay Pratap’s Post

𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬 𝐃𝐚𝐲 𝟐𝟎𝟐𝟒!!! Today, we celebrate the incredible contributions of patients, regulators, sponsors, and clinical research organisations (CROs) involved in Clinical Research. Clinical trials have become the backbone of medical advancements, ensuring that new treatments are safe, effective, and tolerable. Today is celebrated for a significant mark in history made by James Lind back in 1747—a moment that shaped the fabric and future of clinical trials to improve the lives of patients around the globe. As we strive towards the globalisation of clinical trials, it's crucial to underscore the significance of diversity. Diversity is a key factor in any regulatory approval, enabling us to fully comprehend the benefits and risks of investigational medicinal products (IMPs). In this context, we must always uphold the principle of "𝐅𝐢𝐫𝐬𝐭, 𝐝𝐨 𝐧𝐨 𝐡𝐚𝐫𝐦 𝐭𝐨 𝐭𝐡𝐞 𝐬𝐮𝐛𝐣𝐞𝐜𝐭𝐬". #Clinicaltrialsday #Patients #ICTD2024 #ISCR #ClinicalResearch

https://lnkd.in/dYHgYf7z Clinical evaluation plans are essential components in the development and assessment of medical devices, ensuring their safety and efficacy for patients. By outlining a structured approach to collecting and analyzing clinical data, these plans play a crucial role in meeting regulatory requirements and demonstrating the performance of the device. This article (https://lnkd.in/dYHgYf7z) provides an overview exploration of the key elements involved in creating a comprehensive clinical evaluation plan for medical devices, including regulatory considerations, data collection strategies, risk management, compliance requirements, stakeholder engagement, and post-market surveillance. #fda #ivd #ivdr #invitrodiagnostics #medicaldevices #mdr #clinicaltrials #medicaldevice #clinicaltrial #clinicalevaluation #biostatistics

From small initial volumes to full national supply RDi will ensure scalability and be with you at every step of the process ensuring clear communication and transparency.

✅Interesting Fact About the In Vitro Diagnostic Regulation (IVDR) Did you know the IVDR (EU 2017/746) introduces stricter safety and performance standards for in vitro diagnostic devices? It also mandates robust clinical evidence and a centralized database for transparency. These changes highlight the need for expert regulatory support and services! To better understand your expectations and needs, we’ve created a short questionnaire. Your feedback will help us provide the most efficient and effective regulatory support possible. 👉 https://lnkd.in/eQF9y8Jz Your insights are invaluable. How can we best support your journey through the IVDR? #MedicalDevice #IVDR #Regulatoryconsultancy #HealthCare #IVD #clinicalEvidence #invitrodiagnostic

What’s the DLT period in a clinical trial, and why is it so important? The DLT period stands for the dose-limiting-toxicity period of a clinical trial. This period usually encompasses the first few weeks/months of an early phase trial. The importance of this period is to assess whether the investigational product is tolerable and safe. During this period, the medical team and research team watch vigilantly for any signs of diminished organ function or drug toxicity. This period also helps the sponsor pinpoint optimal dose levels, as well as guide dose escalation decisions.

🔬 Welcome to Episode 2 of Our Clinical Trials Series! 🎥 In this episode, we address a common misconception: many people believe that clinical trials are unsafe. While it’s true that clinical trials are experimental in nature, they are rigorously designed to prioritize safety and ethical standards. Participants in clinical trials receive investigational drugs only after extensive testing and evaluation. These trials undergo strict regulatory oversight to ensure the well-being of participants and the integrity of the research. Understanding the safety protocols in place is crucial for dispelling myths about clinical trials. Join us as we continue to explore the vital role clinical trials play in advancing medical research and patient care. #CareerInPharma #ClinicalTrials #Research #PatientSafety #MedicalResearch #HealthcareInnovation

#Clinicaltrial specimen collection comes with its challenges, from insufficient specimens to labelling, tracking and timeline pressures. This is why RDi ensures all its products and services are compatible with the needs of this sector. We offer bulk supply and delivery of kits and packaging products, which can be pre-labelled with subject or patient details for phase I, II and III trials. We’ve delivered over 100 million kits to date, with our products integrating with study participant data to streamline specimen collection. Built in compliance accelerates the testing and transport of clinical trial samples to expedite the discovery and qualification of new treatments! Partner with RDi to transform your clinical trials: https://bit.ly/3zpK7gz #drugdevelopement #clinicalresearch #clinicaltrial

🚀 New MDCG guidance publication - MDCG 2024-10 🚀 It  provides crucial insights into the clinical evaluation of orphan medical devices.  Orphan medical devices cater to rare diseases, often with very few diagnostic or therapeutic options available. This guidance aims to balance the stringent requirements of the MDR with the unique challenges faced by orphan devices, ensuring timely patient access while maintaining high safety standards. 🔹 Key Highlights: 1. Orphan Device Status & Indications: Clarifications on criteria for orphan devices and the justification process. 2. Clinical Evaluation Considerations: Guidance on pre-market and post-market clinical data requirements. 3. Procedural Considerations: Enhanced roles for notified bodies and expert panels in ensuring the safety and efficacy of orphan devices. 📄 Read the full MDCG 2024-10 document here: #MedicalDevices #OrphanDevices #HealthcareInnovation #MDCG #EURegulations

FDA publishes draft guidance on collecting demographic data for clinical trials and clinical studies 🌐 The FDA has just released a draft guidance on collecting demographic data for clinical trials and studies. Titled "Collection of #Race and #Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products," this guidance aims to standardize data collection, ensuring consistency in submissions to the FDA. https://lnkd.in/egwhwqaD #clinicalresearch #clinicaltrials #clinicaloperations #regulatoryaffairs #RAPS #ACRP #clinicaldevelopment

Understanding the importance and intricacies of clinical evaluation plans is vital for manufacturers, healthcare providers, regulators, and other stakeholders involved in the medical device industry. This article (https://lnkd.in/dyaj2Ywd) provides an overview exploration of the key elements involved in creating a comprehensive clinical evaluation plan for medical devices, including regulatory considerations, data collection strategies, risk management, compliance requirements, stakeholder engagement, and post-market surveillance. Please click on the link (https://lnkd.in/dyaj2Ywd) to read the article. #fda #ivd #ivdr #invitrodiagnostics #medicaldevices #mdr #clinicaltrials #medicaldevice #clinicaltrial #clinicalevaluation #biostatistics