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With their extensive knowledge across various drug classes, formulations, and therapeutic areas, Medical Monitors are invaluable to CROs and Sponsors. Read how their strategic guidance and oversight help navigate the complexities of modern clinical trials. https://hubs.ly/Q02fdFBt0 Al Blunt #clinicaltrials #clinicalresearch #drugdevelopment

Hii everyone. my first post on LinkedIn l'm thrilled to share l have successfully completed the"Good Clinical practice-ICH Guidelines E6 R2"certification. l am happy to say that l passed the "Good clinical practice-ICH GuidelinesE6 R2" exam this comprehensive program provided me knowledge of Investigation Brochure, pharmacology, pharmacokinetics, clinical research,GCP,ICH regulatory body. #GCP,#Clinical research,#Clinical trail,#lCH,# GCP guidelines,#carrier Development.

MSLs and advisory board meetings #medicalscienceliaison #advisoryboards Why hold an advisory board meeting? Pharma invest heavily in bringing new therapeutic drugs to the doctors and their patients to help them manage, treat and sometimes even cure their diseases. These new agents are undergoing expensive phase 1, 2, and 3 clinical trials to establish that these drugs (or devices) are safe, tolerable, efficacious, more convenient and/or better (or no worse) than the current standard of care (SOC). Pharma companies want to make sure that what they are developing is actually seen as being a valuable addition to the doctors, their patients and their disease. And also, to understand if the market is ready for this new product, and if it is not yet, what needs to be done and put in place in the (near) future in order to have a successful launch of the drug. Pharma companies therefore ask advice from local key opinion leaders (KOLs) during an advisory board (ad board) meeting. Advisory boars are a key activity for medical affairs and medical science liaison. ➡ Click on the link below to learn more https://lnkd.in/gwMJDE5d

FDA CDER just established a new center of excellence for "Quantitative Medicine". From the announcement on a public meeting on the center, Quantitative Medicine "QM involves the development and application of exposure-based, biological, and quantitative modeling and simulation approaches derived from nonclinical, clinical, and real-world sources to inform drug development, regulatory decision-making, and patient care. " That would seem to put bioanalytical and biomarker measurements center stage. Info on the virtual workshop are at this link. #FDA #CDER #quantitativemedicine

The latest issue of Rx Factor, a prominent newsletter by the @National Association of Pharmacology & Therapeutics, has highlighted the importance of integrating clinical pharmacology into mainstream healthcare. One of the key frameworks discussed is the CPRRF (Clinical Pharmacological Reconciliation, Review, and Feedback) strategy. This comprehensive approach is pivotal in enhancing patient care, especially for the elderly, by rationalizing polypharmacy, preventing adverse drug reactions, and ensuring medication adherence—a mission very close to our heart at MedpeR®. As we continue our journey with MedpeR®, a Smart PillBox designed to ensure timely and anxiety-free medication adherence, it's inspiring to see the ongoing essential efforts to increasingly integrate clinical pharmacologists into patient care, a step that aligns with our goal of making healthcare safer and more effective for everyone. Forever Grateful to my Mentor Dr Shambo Samrat Samajdar! Let’s continue to push the boundaries of what’s possible in healthcare! 💊🩺 Read more in the full Rx Factor issue: https://lnkd.in/gJhYKx9N #HealthcareInnovation #Pharmacology #PatientSafety #MedpeR #ClinicalPharmacology #medicationadherence #digitalhealth

🗺️ To Attend an Upcoming Symposium on Advanced Therapy Medicinal Products (ATMPs) I am thrilled to be part of a special symposium that marks a significant milestone-15 years of groundbreaking advancements in Advanced Therapy Medicinal Products (ATMPs). This event will not only celebrate this remarkable journey but also highlight how the work of the Committee for Advanced Therapies (CAT) has been instrumental in shaping the regulatory framework in Europe. Their efforts have led to the approval of 27 innovative gene- and cell-based therapies, offering new hope for patients with unmet medical needs. This symposium will give a unique opportunity to gain valuable insights into the evolution of CAT, discuss regulatory developments, and explore upcoming innovations that could revolutionize patient care in the next 15 years. - Learn about the evolution of CAT and how it has adapted to meet the challenges of emerging ATMP technologies. - Discuss with experts the regulatory developments that continue to shape the future of ATMPs. - Explore the upcoming innovations that have the potential to revolutionize patient care in the next 15 years. I’m looking forward to engaging with Frontier to develop drugs and other industry leaders, scientists, and regulatory experts. These conversations are essential as we work together to ensure that high-quality, safe, and effective therapies continue transforming the healthcare landscape. I will share insights from the symposium with my network and continue building collaborations that will help advance these revolutionary treatments. I encourage you to do the same and look forward to staying connected as we collectively shape the future of medicine! #ATMPs #GeneTherapy #CellTherapy #HealthcareInnovation #ClinicalTrials #RegulatoryAffairs #CAT #EMA #MedicalInnovation #CNRResearch

About Clinical research.🚀✨📚📖 Clinical research plays a crucial role in advancing medical knowledge, improving patient care, and shaping the future of healthcare. Here are some key aspects of clinical research: 1. Purpose: Clinical research aims to ✨💉🚀investigate the safety and effectiveness of new medical treatments, drugs, devices, and therapeutic interventions. It also explores ways to improve existing medical practices. 2. Phases of Clinical Trials:💊💉 - Phase I: Initial testing on a small group to assess safety and dosage. - Phase II: Further testing to evaluate effectiveness and side effects on a larger group. - Phase III: Large-scale testing to confirm results, monitor side effects, and compare to existing treatments. - Phase IV:Post-marketing surveillance to monitor long-term effects after approval. 3. Key Players:⚕️🥼🩺👨⚕️ - Principal Investigator (PI): Leads the research team and oversees the trial. - Clinical Research Coordinator (CRC):Manages day-to-day operations and ensures compliance. - Sponsor:Provides funding, often a pharmaceutical company or research institution. - Ethics Committees⚖️: Ensure the study adheres to ethical standards. 4. Informed Consent: Participants are fully informed about the trial's purpose, risks, and benefits before agreeing to participate. Informed consent is a fundamental ethical principle. 5. Data Collection and Analysis: Rigorous data collection methods are employed, and statistical analysis is conducted to draw meaningful conclusions from the study results. 6. Regulatory Compliance:Clinical trials must adhere to strict regulatory standards to ensure participant safety and the reliability of the findings. Regulatory bodies vary by country, with the FDA (Food and Drug Administration) being a key authority in the United States. 7. Publication and Sharing:Results are typically published in scientific journals to contribute to the broader medical knowledge base. Sharing findings ensures transparency and helps shape future research. Clinical research is a collaborative effort that requires the dedication of skilled professionals to advance medical science and ultimately improve patient outcomes. If you're considering a career in this field, it offers a unique opportunity to contribute to transformative breakthroughs in healthcare. #ClinicalResearch #HealthcareInnovation 🌐🔬

Check out this call for papers for the special issue of International Journal of Clinical Pharmacy

Imagine a patient in a clinical trial receiving a placebo instead of the actual treatment. But why? What exactly is a placebo? It essentially functions as a dummy treatment - a harmless substance devoid of active ingredients, designed to resemble the medicine being tested. Placebos serve as a crucial benchmark, preventing bias and ensuring the integrity of research results. Reasons why placebos are important in clinical trials: 𝗛𝗲𝗹𝗽 𝗲𝘀𝘁𝗮𝗯𝗹𝗶𝘀𝗵 𝘁𝗵𝗲 𝗲𝗳𝗳𝗶𝗰𝗮𝗰𝘆 𝗼𝗳 𝗮 𝗻𝗲𝘄 𝘁𝗿𝗲𝗮𝘁𝗺𝗲𝗻𝘁: Placebos provide a comparison standard to evaluate the true effects of the investigational treatment. By comparing outcomes between the treated group and the placebo group, researchers can determine its effectiveness beyond the placebo effect. 𝗠𝗶𝗻𝗶𝗺𝗶𝘇𝗲 𝗯𝗶𝗮𝘀 𝗮𝗻𝗱 𝗲𝗻𝘀𝘂𝗿𝗲 𝗿𝗲𝗹𝗶𝗮𝗯𝗶𝗹𝗶𝘁𝘆 𝗼𝗳 𝘀𝘁𝘂𝗱𝘆 𝗿𝗲𝘀𝘂𝗹𝘁𝘀: The use of placebos helps control for the influence of the placebo effect and other confounding factors that could skew the study results, allowing for blinding of participants and researchers to prevent bias in treatment evaluation. 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗯𝗼𝗱𝗶𝗲𝘀 𝗼𝗳𝘁𝗲𝗻 𝗿𝗲𝗾𝘂𝗶𝗿𝗲 𝘁𝗵𝗲 𝘂𝘀𝗲 𝗼𝗳 𝗽𝗹𝗮𝗰𝗲𝗯𝗼𝘀 𝗳𝗼𝗿 𝗮𝗽𝗽𝗿𝗼𝘃𝗮𝗹 𝗼𝗳 𝗻𝗲𝘄 𝗱𝗿𝘂𝗴𝘀 𝗮𝗻𝗱 𝘁𝗿𝗲𝗮𝘁𝗺𝗲𝗻𝘁𝘀: Placebo-controlled trials are frequently mandated by regulatory agencies like the FDA to rigorously evaluate the safety and efficacy of investigational drugs before approval, generating high-quality data needed to meet regulatory standards for new medical products. Placebos are not just inert substances; they are essential tools that enable researchers to evaluate the true efficacy and safety of new treatments. By including placebos, research integrity is upheld, bias is minimized, and the way is paved for groundbreaking medical discoveries that enhance patient care. #Clinicaltrials #Clinicalresearch

CDER Conversation: Streamlining Drug Development and Improving Patient Care: CDER Quantitative Medicine Center of Excellence In this CDER Conversation, Rajanikanth Madabushi, lead for CDER’s Quantitative Medicine (QM) Center of Excellence (CoE) and associate director for Guidance and Scientific Policy in the Office of Clinical Pharmacology in the Office of Translational Science Super Office explains the purpose of the new CoE, provides an overview of current activities and resources, and shares ways the CoE can advance drug development and improve patient care. The goal of the QM CoE is to facilitate and coordinate the continuous evolution and consistent application of QM across CDER. The QM CoE encourages all stakeholders to explore how they can help the QM CoE advance and integrate QM to maximize societal benefit and patient care.  #fda #CDER #patientcare #centerofexcellence #patient https://lnkd.in/giG9nuVH