Cloudbyz CTMS’ Post

Learn how the Cloudbyz Vet eClinical Platform aligns with the latest FDA guidelines https://hubs.li/Q02ynDdD0

Learn how the Cloudbyz Vet eClinical Platform aligns with the latest FDA guidelines https://hubs.li/Q02ynCgL0

Did you know that clinical trials don’t stop after a drug is approved? The 'consult your doctor' note on medication packaging is a part of ongoing post-marketing surveillance that ensures safety and effectiveness in real-world use. This is a reminder of the continuous efforts in healthcare to prioritize patient safety and improve outcomes. Stay informed, stay safe! #xceneresearch #clinicaltrials #patientsafety #pharmacovigilance #healthcareinnovation #continuousimprovement

Today, the CIOMS has published a report on "Introduction to MedDRA Labeling Grouping (MLG): A standardized approach to grouping adverse reactions in product safety labels (2024)". MedDRA Labeling Groupings (MLGs) are groups of preferred terms (PTs) representing similar or near-synonymous medical concepts. The aim of such MLGs is to ensure consistent and accurate presentation of adverse drug reactions (ADRs) in various products safety labels. MLGs, through harmonization, can significantly improve upon the current diverse and non-harmonized approaches used by different institutions or pharmaceutical companies for clustering similar ADR terms in product safety labels. Consequently, this approach will further enhance safety communication to healthcare professionals. For more details, please refer to complete report here (freely available for download): https://lnkd.in/ez9mNP3v

Is an accelerated pathway the right choice for your product? At NDA, we know how crucial a well-planned and executed regulatory strategy is for a collaborative and rapid review, approval and introduction of a new treatment to the patients that need it. Contact us to discuss how our team can help you make the right choice. #ndagroup #medicine #approval #accelerationstrategies #regulatoryaffairs

Our Step by Step Guide to EUDAMED Registration

🌟 Exciting News Alert! 🌟 Thrilled to share that our latest blog post, "Empowering Patients: The Vital Role of Patient Engagement in Pharmacovigilance," has just been published on the Excellence Gurus website! 💊💡 In today's dynamic healthcare landscape, patient safety remains paramount. As medical interventions evolve and pharmaceutical innovations emerge, vigilance in monitoring medication safety and efficacy becomes increasingly crucial. And guess what? Patients play a pivotal role in this process! In our latest blog, we delve into the indispensable contribution of patients to pharmacovigilance. From sharing their lived experiences to reporting adverse reactions and advocating for improved practices, patients are not just passive recipients of medical care; they are integral contributors to ensuring medication safety for all. Curious to learn more about the vital role patients play in pharmacovigilance? Dive into our blog post now: [https://lnkd.in/eb8hrM9n] Let's continue to empower patients, enhance medication safety, and improve healthcare outcomes together! 💪🏥 #PatientEmpowerment #Pharmacovigilance #HealthcareInnovation #ExcellenceGurus #PatientSafety #Regulatory #complaince

Read our Goodwin regulatory blog on the now-issued, long-awaited Diversity Action Plans draft guidance from the FDA - the good news for industry is that the guidance remains draft in form and these requirements will only kick-in following issuance of final guidance from FDA on this topic. #goodwinlaw #lifesciences

30% Faster AE Reporting with Cloudbyz! In a recent surgical valve trial, the sponsor reduced the time spent on submitting expedited AE reports by 30% using the Cloudbyz Safety Database. Simplifying safety reporting every step of the way. We’re at the World Drug Safety Congress Europe this week! Meet our team to learn how Cloudbyz can help streamline your safety processes. Meet the team in Amsterdam: https://hubs.li/Q02S9d4y0 Not attending? You can still book a demo here: https://hubs.li/Q02S9fZm0 #Cloudbyz #Pharmacovigilance #AEReporting #Compliance #SafetyDatabase #LifeSciences #MeetUs #WorldDrugSafety

The CIOMS has recently introduced the MedDRA Labeling Grouping (MLG), which is a standardized and international approach to grouping adverse reactions in product safety labels. The aim of this working group is to provide better safety communication to patients and healthcare providers. There is an urgent need for a harmonized approach to creating and using groups of MedDRA terms, or "MedDRA Labeling Groupings (MLGs)", in medical product prescribing information. If you want to read the full document, click here - https://lnkd.in/dRpjHJEg #Pharmacovigilance #DrugSafety #PatientFirst #PatientCentricity