Sabyasachi Sengupta’s Post

🌟 Navigating Clinical Evaluation Reports (CERs) with MDS Denmark 🌟 The landscape of medical device regulation is evolving, and at the heart of this transformation are Clinical Evaluation Reports (CERs). With the introduction of the Medical Device Regulation (MDR), the stakes have never been higher for proving the safety and efficacy of medical devices. CERs are now more than just a regulatory requirement; they are a critical tool in navigating market authorization. Transitioning from the Medical Device Directive (MDD) to the MDR has introduced a paradigm shift in requirements. The focus has shifted towards a detailed analysis of General Safety and Performance Requirements (GSPRs), demanding a meticulous process that includes an exhaustive collection and analysis of clinical data. This heightened scrutiny ensures that only devices that truly meet the highest standards of safety and efficacy make it to the market, enhancing patient protection. How MDS Denmark Can Help You Craft Compliant CERs Under MDR: 📝  Clear Clinical Evaluation Plan (CEP): Our experts will work with you to define a comprehensive plan that outlines the methodology, objectives, and criteria for your clinical evaluations, including post-market clinical follow-up (PMCF). We ensure your CEP addresses all relevant MDR sections, setting a solid foundation for regulatory compliance.   🛠 Thorough Device Description: We assist in detailing your device’s specifications, design rationale, intended use, and target patient demographics. Our team ensures a comprehensive and precise description that includes physical, chemical, biological, and technical characteristics, supplemented with images or drawings for clarity.   🔍 Clinical Evidence Compilation: MDS Denmark will help gather and critically analyze clinical evidence from a variety of sources, including clinical investigations, literature reviews, and post-market surveillance data. Our systematic approach ensures a comprehensive and balanced report, supporting a well-rounded evaluation of your device.   ⚖ Benefit-Risk Analysis: Our team conducts detailed benefit-risk analyses to prioritize patient safety and demonstrate compliance with GSPRs. We ensure that the benefits of your device are clearly documented to outweigh any potential risks, meeting the stringent requirements of the MDR.   📊 Ongoing Monitoring: We develop robust strategies for continuous device evaluation, incorporating new clinical evidence and post-market data. MDS Denmark ensures that your CER remains current and reflective of the latest regulatory and clinical insights. For more information about Clinical Evaluation Reports and how we can help your company navigate these challenges, feel free to contact us at: [email protected] / +45 2712 4712 Or book a meeting directly here: https://lnkd.in/e5xr9P4S #MDR #CER #ClinicalEvaluation #RegulatoryAffairs #QualityManagement 

The focus on medical research has had both positive and negative impacts on patient care. Positive impact: 1. Improved Treatment: Medical research has led to the development of innovative treatments and interventions that have significantly improved patient outcomes. New drugs, therapies, and medical devices have been discovered through research, delivering better options for patient care. 2. Early Detection and Prevention: Research has contributed to the identification of risk factors, biomarkers, and early detection methods for various diseases. This enables timely intervention and preventive measures, reducing the burden of diseases on patients. 3. Evidence-Based Medicine: Medical research provides healthcare professionals with evidence-based guidelines and protocols to follow. These guidelines enhance patient care by ensuring that treatments are backed by scientific evidence and are more likely to be effective. Negative impact: 1. Cost of Innovation: Developing new drugs, therapies, or medical devices is an expensive process involving extensive research, clinical trials, and regulatory approvals. These costs often get transferred to patients through increased healthcare costs and prescription drug prices, making certain treatments less accessible or affordable. 2. Delayed Implementation: The time it takes for research findings to be translated into clinical practice can be significant. This delay may prevent patients from accessing the most advanced treatments or interventions immediately, potentially affecting their care and outcomes. 3. Misallocation of Resources: The focus on certain areas of medical research, such as rare diseases or high-profile conditions, may result in limited resources being allocated to other important healthcare areas. This can lead to neglecting certain patient populations or conditions that do not receive adequate attention or funding. Overall, while medical research has greatly advanced patient care, it is essential to strike a balance between innovation and ensuring accessibility, affordability, and equal distribution of resources to provide optimal care for all patients.

Top 5 Challenges Faced by Clinical Research Coordinators and How to Overcome Them As a former Clinical Research Coordinator (#CRC) in Basavatarakam Cancer Hospital and Research Institute , I can attest that this role is both rewarding and challenging. CRCs play a crucial role in clinical trials, but they often face numerous obstacles. Let's explore the top 5 challenges and strategies to overcome them. 1. Balancing Patient Care and Administrative Work Challenge: Managing patient work while simultaneously handling EDC (Electronic Data Capture) tasks can be overwhelming. Solution: - Prioritize tasks using time management tools - Allocate specific time blocks for EDC work 2. Managing Multiple Studies and Patients Challenge: Being delegated to multiple studies with numerous patients can lead to information overload and potential oversights. Solution: - Create a master schedule for all studies - Use color-coding systems for different studies - Implement a robust tracking system for patient follow-ups 3. Coordinating with Principal Investigators (PIs) and Patients Challenge: Constantly following up with PIs and patients for lab work, scans, and other study-related activities can be time-consuming and frustrating. Solution: - Use reminder systems (e.g., automated texts or emails) - Build strong relationships to improve cooperation 4. Handling On-Site Monitoring Visits Challenge: On-site monitoring visits add extra pressure, requiring CRCs to work with CRAs while still managing regular duties. Solution: - Prepare for monitoring visits well in advance - Create a monitoring visit checklist - Delegate non-urgent tasks to team members during monitoring days 5. Physical and Mental Fatigue Challenge: The role often involves significant physical work and mental strain, leading to burnout. Solution: - Practice self-care and stress-management techniques - Take regular breaks and use ergonomic equipment Personal Reflection: During my time as a CRC, I often wished for "10 hands and legs" to manage the workload, especially during on-site monitoring. The job required juggling patient care, EDC work, and collaborating with CRAs, all while ensuring the smooth running of multiple studies. Despite the challenges, working as a CRC provides invaluable real-world experience in clinical research. It hones your multitasking abilities, improves your communication skills, and gives you a comprehensive understanding of the clinical trial process. Conclusion: While the role of a CRC is undoubtedly demanding, it's also incredibly fulfilling. By implementing effective strategies and maintaining a positive attitude, CRCs can overcome these challenges and excel in their crucial role in advancing medical research. Have you faced similar challenges as a CRC? What strategies have you found effective? Share your experiences in the comments below! #ClinicalResearch #CRC #ClinicalTrials #HealthcareInnovation #ProfessionalDevelopment

Request for Proposals

🚀 Navigating Clinical Evaluation Reports (CERs) with MDS Finland 🚀 The landscape of medical device regulation is evolving, and at the heart of this transformation are Clinical Evaluation Reports (CERs). With the introduction of the Medical Device Regulation (MDR), the stakes have never been higher for proving the safety and efficacy of medical devices. CERs are now more than just a regulatory requirement; they are a critical tool in navigating market authorization. Transitioning from the Medical Device Directive (MDD) to the MDR has introduced a paradigm shift in requirements. The focus has shifted towards a detailed analysis of General Safety and Performance Requirements (GSPRs), demanding a meticulous process that includes an exhaustive collection and analysis of clinical data. This heightened scrutiny ensures that only devices that truly meet the highest standards of safety and efficacy make it to the market, enhancing patient protection. How MDS Finland Can Help You Craft Compliant CERs Under MDR: 📝 Clear Clinical Evaluation Plan (CEP): Our experts will work with you to define a comprehensive plan that outlines the methodology, objectives, and criteria for your clinical evaluations, including post-market clinical follow-up (PMCF). We ensure your CEP addresses all relevant MDR sections, setting a solid foundation for regulatory compliance. 🛠 Thorough Device Description: We assist in detailing your device’s specifications, design rationale, intended use, and target patient demographics. Our team ensures a comprehensive and precise description that includes physical, chemical, biological, and technical characteristics, supplemented with images or drawings for clarity. 🔍 Clinical Evidence Compilation: MDS Finland will help gather and critically analyze clinical evidence from a variety of sources, including clinical investigations, literature reviews, and post-market surveillance data. Our systematic approach ensures a comprehensive and balanced report, supporting a well-rounded evaluation of your device. ⚖️ Benefit-Risk Analysis: Our team conducts detailed benefit-risk analyses to prioritize patient safety and demonstrate compliance with GSPRs. We ensure that the benefits of your device are clearly documented to outweigh any potential risks, meeting the stringent requirements of the MDR. 📊 Continuous Evaluation Strategies: We develop robust strategies for continuous device evaluation, incorporating new clinical evidence and post-market data. MDS Finland ensures that your CER remains current and reflective of the latest regulatory and clinical insights. For more information about Clinical Evaluation Reports and how we can help your company navigate these challenges, feel free to contact us at: [email protected] / +358 50 552 8828. You can also book a meeting from our Calendly: https://lnkd.in/d8vujjZW #MDR #MedicalDevices #CER #RegulatoryAffairs #QualityManagement #ClinicalEvaluation

Request for Proposals (RFP) Increase Awareness & Understanding of Emerging Hemophilia Treatment Options Pfizer Global Medical Grants (GMG) supports the global healthcare community’s independent initiatives (e.g., research, quality improvement, or education) to improve patient outcomes in areas of unmet medical need that are aligned with Pfizer’s medical and/or scientific strategies. Pfizer’s GMG competitive grant program involves a publicly posted Request for Proposal (RFP) that provides detail regarding a general area of interest, sets timelines for review and approval, and uses an internal Pfizer review process to make final grant decisions. Organizations are invited to submit an application addressing the knowledge gaps as outlined in the specific RFP. For all independent medical education grants, the grant requester (and ultimately the grantee) is responsible for the design, implementation, and conduct of the independent initiative supported by the grant. Pfizer must not be involved in any aspect of project development, nor the conduct of the independent education program. Date RFP Issued: June 26, 2024 Geographic Scope: Global (excluding United States) Clinical Area: Hemophilia Link to full RFP: Increase Awareness & Understanding of Emerging Hemophilia Treatment Options Application Due Date: Rolling due dates - please see RFP for detaills Specific Area of Interest: Projects that will be considered for Pfizer support will focus on: Educating on the evolving treatment landscape (i.e. genetic medicine, rebalancing strategies) for hemophilia to improve the understanding of these novel approaches and their potential clinical applicability. Discussing shared decision making (SDM) and practical approaches on how SDM can be incorporated into hemophilia patient care Educating on the benefits of omnichannel healthcare strategies which can provide a seamless, personalized service and patient care experience Sharing knowledge and best practices (i.e. staff training, SOP, follow-up care) on how Hemophilia Treatment Centers (HTCs) and multidisciplinary team are preparing for novel therapies in development Advancing patient education on the evolving hemophilia treatment landscape and improving patient’s empowerment and ability to make informed decisions about their care

Demystifying Phase 1 Clinical Trials: A Deep Dive Phase 1 clinical trials mark the initial foray of a potential new treatment into the human body. While often shrouded in mystery, these trials play a vital role in medical advancement. Today, we'll delve into the intricacies of Phase 1 trials, exploring their importance, goals, the motivations of healthy volunteers, and the nitty-gritty of how they're conducted. Importance of Phase 1 Trials Phase 1 trials lay the groundwork for the entire clinical development process. They provide the first-in-human data critical for understanding: • Safety: How the new treatment interacts with the human body and potential side effects. • Dosage: Identifying the safe and effective dose range. • Pharmacokinetics: How the body absorbs, distributes, metabolizes, and excretes the treatment. This information guides further trials, paving the way for potential breakthroughs in disease treatment. Goals of Phase 1 Trials These trials are meticulously designed to achieve specific goals: • Safety Assessment: The primary objective is to determine if the treatment is safe for human use at various doses. • Dose-Limiting Toxicity (DLT): Identifying the highest tolerable dose before severe side effects occur. • Pharmacokinetic Profile: Understanding how the body processes the treatment. • Preliminary Efficacy Signals: While not the primary focus, some trials may look for early signs of effectiveness. Why Healthy Volunteers Participate? Healthy volunteers are the backbone of Phase 1 trials. Their motivations can be multifaceted: • Altruism: A desire to contribute to medical progress and benefit future patients. • Financial Compensation: Trials often offer compensation for time and potential discomfort. • Access to Advanced Care: Participants receive close medical monitoring throughout the trial. • Increased Awareness: Gaining a deeper understanding of a specific disease or treatment. The Conduct of a Phase 1 Trial These trials are tightly controlled and involve a small group (20-100) of healthy volunteers. Here's a simplified breakdown of the process: ✓ Screening: Volunteers undergo rigorous medical evaluations to ensure eligibility. ✓ Informed Consent: A detailed explanation of the trial process, risks, and benefits is provided. ✓ Dose Escalation: The treatment is administered in gradually increasing doses to cohorts of volunteers. ✓ Close Monitoring: Participants are meticulously monitored for any side effects or reactions. ✓ Data Collection: Extensive data on safety, pharmacokinetics, and preliminary efficacy is meticulously collected. Conclusion Phase 1 trials, while often unseen, are the cornerstone of medical progress. By understanding their importance, goals, and the selfless contributions of healthy volunteers, we can appreciate the intricate dance that brings new treatments from bench to bedside. #ClinicalTrials #Phase1 #MedicalResearch #DrugDevelopment

👋 A Chance Encounter and a New Beginning Life has a funny way of bringing people together when you least expect it. Just the other day, I was walking down the city center when I unexpectedly bumped into my cousin, whom I hadn’t seen in years. We were both surprised and delighted by the chance encounter. As we caught up over coffee, he asked me what I did for a living. When I mentioned that I worked in clinical trials, he looked puzzled and admitted he didn’t know much about the field. This conversation sparked an idea in me. I realized that many people, like my cousin, might not be aware of the crucial role clinical trials play in advancing medical science and improving patient care. After this realization, I decided to create this post to shed light on the importance of clinical trials and how they contribute to the development of new treatments and therapies. 🌟 Understanding Clinical Trials: Why They Matter 🌟 What are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. They are the backbone of medical advancements, helping us discover new ways to prevent, detect, or treat diseases. 🏥 Why Should You Care? - Innovation in Healthcare: Clinical trials are the driving force behind new treatments and therapies. Without them, we wouldn’t have the life-saving medications and procedures we rely on today. 💊 - Safety First: Before any new treatment is available to the public, it must pass through rigorous testing in clinical trials to ensure it’s safe and effective. This means better, safer options for everyone. 🛡️ - Hope for Patients: For many patients, clinical trials offer access to cutting-edge treatments that aren’t available elsewhere. They provide hope and potential new options when standard treatments aren’t enough. 🌈 - Advancing Science: Every clinical trial contributes valuable data that helps scientists understand diseases better and develop even more effective treatments in the future. 📊 How Can You Get Involved? - Stay Informed: Follow clinical research news and updates to stay in the loop about the latest advancements. - Participate: If you or a loved one is eligible, consider participating in a clinical trial. It’s a way to contribute to science and potentially benefit from new treatments. - Spread the Word: Share information about clinical trials with your network. The more people know, the more we can advance together! - Work in Clinical Trials: Consider a career in clinical research. There are many different roles, from data management and monitoring to patient care and biostatistician, that contribute to the success of clinical trials. Clinical trials are a crucial part of our healthcare system, paving the way for a healthier future. Let’s celebrate the innovation and dedication that goes into every trial and support the journey towards better health for all. #ClinicalTrials #HealthcareInnovation #PatientCare #ScienceMatters

📣 Regulatory Update: MDCG 2024-10 Clinical evaluation of orphan medical devices   Orphan medical devices are defined in the new guidance as device intended for rare conditions affecting fewer than 12,000 people in the EU annually. The guidance outlines criteria for a device to qualify as an orphan device, emphasizing the lack of alternative treatments and expected clinical benefits.   The Medical Device Regulation (MDR) in the EU has high requirements for the clinical evidence for in particular high risk devices, making it difficult for manufacturers to maintain orphan devices in the market, or market new devices. For such devices, there is a challenge to generate sufficient pre-market clinical evidence due to their limited patient populations. The Medical Device Coordination Group (MDCG) acknowledges these challenges and suggests a balanced approach to MDR requirements for orphan devices, ensuring patient access without compromising safety. While requiring sufficient clinical evidence is important to ensure the safety of patients, also the potential absence of devices in the market that are required to treat rare diseases or vulnerable patient collectives as infants and children has ethical implications. As consequence, there is a need to balance the need for clinical evidence with the practicalities of developing treatments for rare conditions. As an example, a device used in pediatric heart surgery can save the life of neonates, however a randomized controlled clinical trial on several hundreds of patients as would normally be expected for such type of high-risk device may be not feasible to conduct in the pre-market phase.   The MDCG's guidance document, MDCG 2024-10, offers advice on clinical evaluation and procedural considerations for orphan devices. It allows for market access with limited pre-market data, provided that there is transparency about the device's limitations and a robust PMS and PMCF plan to gather further data.   For manufacturers, demonstrating an orphan device's status involves providing epidemiological evidence and justifying the device's clinical benefit over existing alternatives. Notified bodies play a crucial role in assessing orphan devices, potentially setting specific conditions for certification, and ensuring ongoing post-market surveillance with specific methods for PMCF. The expert panels organized by EMA/Expamed offer advice on orphan device status and clinical data requirements, contributing to the decision-making process for market access.   In summary, the MDCG's guidance aims to support the availability of orphan devices while maintaining patient safety and upholding regulatory standards.

Subtle Changes in the Ongoing Medical Information DX, After Corona? Survey on DX in Medical Information Provision, About 700 Physicians Responded In a survey conducted by Nikkei Research in March 2023, it was found that the "shift from MRs to digital" in the provision of medical information in the field of medicine and pharmaceuticals has advanced rapidly due to the Corona disaster. Subsequently, in May of the same year, coronas were moved to the same 'category 5' classification as seasonal influenza in the Infectious Diseases Act, making it easier for MRs to visit healthcare facilities, has this had an impact on medical information DX? The survey was conducted in November 2023, and responses were received from 772 physicians. "Mainly digital" at 65%, down 6 points from the previous survey First, let us review the results of the previous surveys. When asked in last March's survey how they obtain information from pharmaceutical companies, only 29% said "mainly from MRs," while 71% said "mainly from digital tools".In a survey conducted in August 2021, the percentage of "from MRs"（40％）was still higher than that of "from digital tools" (28%). In the year and a half since the Corona disaster, when visits to medical institutions were no longer possible, it has become clear that the way information is provided between the physicians and pharmaceutical industries has changed significantly. In a survey conducted last November, six months after the "transition to Class 5," 65% of respondents answered "from digital", a drop of 6 points from the previous survey. The percentage of "from MRs" remained at 35%, indicating that physicians who obtain information via digital tools are still the mainstream. However, the fact that MRs are now more likely to visit medical institutions again seems to be bringing about subtle changes in the medical field. By age group of physicians, it was interesting to note that younger physicians in their 20s and 30s, who have been familiar with digital technology since childhood, increased their response "from MRs" by more than 6 points. Pharmaceutical Industry's DX Not Gaining Physicians' Appreciation The survey also asked physicians which companies they would most appreciate for their DX efforts in providing medical information. 29 companies were named, and physicians were asked to choose only one company. However, the most common response was "don't know/not one of these companies" at 42%. The number of respondents who said, "No company is making progress" also reached 12%. Although this was down from 44% and 14%, respectively, in the March survey, more than half of the physicians were still unable to understand or evaluate the efforts of the companies. Physicians who responded to the first question that they obtain medical information "from digital tools" were more likely to respond "don't know/not one of these companies" or "no company is making progress to the second question.