Clinical ink的动态

Hello LinkedIn Family, ?? Here's a brief about MedDRA. MedDRA: A medical dictionary for Regulatory Activities. It is an International clinically validated terminology developed under ICH. It has an important impact in the safety of drugs as it used in the classification and coding of adverse events to record and analyze the safety of drugs and medical products, by the Regulatory Authorities. MedDRA is sued for specified ICH E2B fields, used in Pre-clinical and the 4 phases of Clinical trials. MedDRA is maintained by MSSO (MedDRA Maintenance and Support Services Organization), which is responsible for all updates, change and addition in it. MedDRA is used for recording: 1.) Medical history, signs and symptoms. 2.) Disease and diagnosis. 3.) Therapeutic indications. 4.) Lab test results. 5.) Surgical and medical procedures. 6.) Health affect and device malfunctions. MedDRA is updated twice a year on 1 March and 1 September every year. As of September 2024, most recent version of MedDRA is 27.1 which was released on 1 March 2024 and it included 1582 change requests with 1206 approved and implemented.

?? Unlock the Potential of EDC for Various Study Designs!??? At #OnlineCRF, our EDC platform is designed to support a wide range of clinical and non-interventional studies, making research more efficient and scalable. Whether you're running clinical trials, postmarketing studies, or medical device investigations, our?platform has you covered! With features tailored to different phases and complexities of research, #OnlineCRF ensures accurate data capture, regulatory compliance, and streamlined study management: ? Clinical Trials (Phases I-IV). ? Postmarketing Studies. ? Medical Device Investigations. Are you ready to enhance your research with a robust EDC system? Let's make your study faster and more efficient!??? ?? Learn more about how we can help here:?https://onlinecrf.com/ #ClinicalTrials #PostMarketing #MedicalDevices #EDC #DataCapture #ClinicalResearch?#ClinicalData #CRO

#FDA recently issued the final #DCT guidance: #Conducting #Clinical #Trials with #Decentralized #Elements (https://lnkd.in/d79Ma9xv). It’s interesting to see FDA's "#multifaceted" focus on #standardizing the definition of #decentralization (both #DCT and #hybrid-DCTs) and also clarifying the #overlap and #convergence with #traditional Clinical Trials (e.g. use of CFR Part 11 #compliant #software, core #Sponsor responsibilities, etc.). The FDA also has an important note for #fully #decentralized #Trials: “Trials where all activities are decentralized may be appropriate for investigational products (IPs) that have well-characterized safety profiles (see section III.G) and do not require complex preparation, administration, or medical assessments.” Will be interesting to see how the #industry adopts these #recommendations. https://lnkd.in/daeWPMPU

Electronic Trial Master File (eTMF) Market size is expected to grow at a CAGR of 9.5% between 2024 and 2032. To know more, visit :- https://lnkd.in/dnEZQrQt Key players are :- Anju Software ArisGlobal Egnyte Clinevo Technologies Cloudbyz . . . . #eTMF #ElectronicTrialMasterFile #ClinicalTrials #ClinicalResearch #PharmaTech #TrialManagement #ClinicalDataManagement #RegulatoryCompliance #HealthcareTechnology #PharmaceuticalResearch #ClinicalOperations #DocumentManagement #LifeSciences #DrugDevelopment #eTMFMarket

Let's start by defining EDC and understanding its importance in clinical trials. EDC stands for Electronic Data Capture, and it has played a vital role in the evolution of patient care technology. With the growing interest in digital health and software as a service sector, continuous data integration has become increasingly important. As a result, EDC Nubilaria has emerged as a cornerstone for clinical trial innovation, offering groundbreaking solutions in electronic data capture and enhancing patient care technology. https://lnkd.in/gJdbedpV #clinicalresearch #healthcaredata #healthcareit #healthcaresoftware #data #healthcare #pharmaceuticals #digitalhealthcare #pharmaceuticaltechnology #clinicalresearch #clinicaltrials #digitalhealth #healthtechnology #healthtech #clinicalresearch #clinical #cro #clinicaldata #clinicaltrialmanagement #clinicalstudies #clinicaldataplatforms #remotehealthcare #remotehealth #clinicaloperations #clinicaldevelopment #clinicaloperations #clinicaldata #remotemonitoring #datamanagementplatform #datamanagement #pharma #lifescience #rwe #rwd #epro #sops #etmf #edc #sdv #edc #cra #rtsm #sae #uat #gcp #qa #ecoa #iwrs #esource #econsent

Let's start by defining EDC and understanding its importance in clinical trials. EDC stands for Electronic Data Capture, and it has played a vital role in the evolution of patient care technology. With the growing interest in digital health and software as a service sector, continuous data integration has become increasingly important. As a result, EDC Nubilaria has emerged as a cornerstone for clinical trial innovation, offering groundbreaking solutions in electronic data capture and enhancing patient care technology.

Clinical trials generate large numbers of samples, and clinical sites may simply lack the resources and expertise to store or process them all. What can help tackle this issue? Our centralized interim sample storage and pre-analytical sample processing. By using these services, you can process your critical samples quickly and accurately. Learn more about the benefits here ?? https://bit.ly/3SnnaSB #PrecisionMedicine #ClinicalTrials #Biomarkers

April 2024 - The impending adoption of ICH E6(R3) promises to elevate the role of the TMF and increase trial efficiency. The GCP guideline will require sponsors to practice quality by design (QbD), an approach that starts with designing quality into every product and service. Ken Keefer explores in this article how ICH E6(R3) may affect the scope of TMF services, the importance of understanding TMF customer needs, and how applying QbD could improve TMF and trial quality. https://lnkd.in/gPyRutEb #tmf #gcp #ich #clinicaltrials

// The impact of patient partnerships in clinical trials // ? By integrating patient feedback early in the process, studies are becoming more patient-friendly, leading to higher compliance rates and the collection of more comprehensive and accurate data. ?? Regulatory agencies like the FDA and EMA have been at the forefront, producing guidelines that emphasize the incorporation of patient perspectives. ?? Discover the transformative impact of patient feedback in clinical research, and the necessity for global recognition and systematic implementation of patient-centric principles: https://bit.ly/3YlfCkU #kayentis #eCOA #clinicaltrials #EmpoweringPatientsVoices #patientcentricity

Let's start by defining EDC and understanding its importance in clinical trials. EDC stands for Electronic Data Capture, and it has played a vital role in the evolution of patient care technology. With the growing interest in digital health and software as a service sector, continuous data integration has become increasingly important. As a result, EDC Nubilaria has emerged as a cornerstone for clinical trial innovation, offering groundbreaking solutions in electronic data capture and enhancing patient care technology.