MedDRA MSSO’s Post

Science is strongly supporting the central role of the patient in all therapies as patient empowerment is pivotal eversince medical practice has moved its first steps in human history. We, at Regenera, strongly embrace the relevance of securing patients' committment and engagement with their therapies and this is indeed a key pillar on our approach for acute spinal cord injury repair: let's make TOGETHER spinal cord injury a thing of the past!

If you're not already doing number 1, chances are you've got some disgruntled sites on your hands. 😬 Learn 3 simple ways sponsor companies can improve sponsor-site relationships from Endo's Rosalie Filling. #clinicaltrials #clinicalresearch

🔔 Standardizing Safety Analysis: MedDRA SMQs vs. FDA Medical Queries in Pharmacovigilance 🔔 Pharmacovigilance professionals, are you streamlining your safety analysis workflows? Both Standardized MedDRA Queries (SMQs) and FDA Medical Queries (FMQs) offer valuable tools for identifying and analyzing adverse events (AEs) in clinical trials and post-marketing surveillance. ❓ But what are the key differences? ❗ SMQs: Developed by the International Council for Harmonisation (ICH), SMQs are pre-defined sets of MedDRA terms for specific safety topics. They're a versatile option for general pharmacovigilance activities and specifically signal detection. ❗ FMQs: Created by the FDA, FMQs focus on specific AEs of high regulatory interest for new drugs and biologics. They ensure a standardized approach for NDA/BLA safety analyses and drug labeling. 💡 The takeaway? Leverage SMQs for broad safety assessments, while FMQs provide a targeted approach for FDA submissions. MedDRA SMQ Training Materials: https://lnkd.in/g7MQVvR9 FDA Medical Queries: https://lnkd.in/ds6UrF5U #pharmacovigilance #drugsafety #MedDRA #FDA #drugdevelopment #druglabel

Thanks to Pharmaceutical Executive for covering our exciting news!   “WebMD Ignite is teaming up with First Databank (FDB) to support patient engagement and health literacy. The partnership will work to improve patient-focused issues such as discharge education and prescription drug safety and adherence. The collaboration will utilize the WebMD Ignite’s Krames on FHIR platform, which provides patients with direct educational content.”   “Effective patient medication education is critical to improving patient outcomes. We need to do more to prevent dosing errors and help patients understand why they are taking their medications. This integration of Meducation with WebMD Ignite's Krames On FHIR platform offers patients of all backgrounds simplified, easy-to-follow, actionable medication instructions, along with other valuable educational content from WebMD Ignite, to help protect their and their family's safety, increase care plan adherence and improve their outcomes," FDB’s Charles Lee, MD, said.   Read more about our partnership which has the goal of improving patient education and treatment directions: https://bit.ly/49LiFre | #PtSafety #MedAdherence #PrescriptionInstructions #Meducation #HealthLiteracy

Jennifer Duff shares 4 key areas that clinical trial technology should deliver to sponsors and CROs when launching a clinical trial. Great information for those organizations looking to be more efficient in the conduct of a clinical trial. The Zelta team takes great pride in delivering a platform that simplifies the complex world of clinical trials. #clinicaldatamanagement #clinicaltrials #zelta #merative

GETTING BIOTECHS GLOBALREADY 🌏 GlobalReady is designed to support biotechs from their early pre-clinical through to later phases. All with the one CRO, across the globe, and leveraging the right site relationships and delivering access to patient populations. 🌐 Watch the video 👇 https://lnkd.in/gTtrcAjS Request a Proposal now! https://lnkd.in/gDgtaSqB #AvanceClinical #CRO #GlobalReadybyAvanceClinical #Biotech #ClinicalTrials #DrugDevelopment #PreClinical #EarlyPhase #LatePhase

So proud of the Validcare development and operations teams for listening to the needs of our investigators and patients who play an invaluable role in #clinicaltrials. We heard that late payment to clinical investigators and patient participants is the norm. That is simply unacceptable. So we engineered automated payment base upon documented completion of work or visit, respectively. Creating an exceptional experience for patients and investigators is key to attracting and retaining participants and professionals to help us evaluate life changing advancements through #clinicalresearch. #pharma #biotech #biopharma #clinicaloperations #CROs #clinicaltrialsday

Meet myself and Seth Nelson (CEO, 83bar) at DPHARM 2024 to discuss how we can QuickStart your clinical trials. Our QuickStart solution can help you expedite enrollment, learn if digital outreach is effective for your trial, which sites take action and patient leads and what it will cost per patient. QuickStart is designed to help: 1. Clinical trial planning and successful launches 🚀 2. Challenges with meeting clinical trial enrollment goals 🎯 3. Provide insights into diversity and inclusion opportunities 💡 Message me if you would like to know more or to organize a catch up at DPHARM. #DPHARM2024 #patientrecruitment