Clinical Data Articles
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Speeding Up Healthcare Innovation Leveraging Cloud Technology
Over the past decade, cloud computing has undergone remarkable expansion. The collective revenue generated by AWS, Google Cloud, and Microsoft surged from $49 billion in 2018 to an astonishing $206 billion in 2022.[i] Projections from Future Market Insights indicate that the revenue from cloud services is poised to maintain an impressive average annual growth rate of 21%, reaching a staggering ...
By Caresyntax
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Top Advances in Echocardiography Transforming Cardiac Imaging on World Heart Day
In honor of World Heart Day on September 29, we're diving into the world of cardiovascular diagnostics. Echocardiography, one of the most widely used screening and diagnostic modalities in healthcare, has seen a resurgence thanks to advances and groundbreaking innovations within the last few years. Join us as we explore the top trends shaping these diagnostic methods. 1. ...
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Autoimmune Diseases Targets
Thymic Stromal Lymphopoietin (TSLP) is a multifunctional cytokine that acts on various cell types, including dendritic cells, T cells, B cells, neutrophils, mast cells, eosinophils, and innate lymphoid cells, affecting their maturation, survival, and recruitment. It is well-known for its role in promoting type 2 immune responses, such as allergic diseases. In 2021, a monoclonal antibody targeting ...
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Development Trends And Potential Challenges of PROTACs
PROTAC technology has been in development for more than 20 years. PROTAC proof-of-concept studies date back to 2001, when Crews' team tested the possibility of artificially induced intracellular protein degradation with a peptide that was too large in molecular weight and required cells to penetrate the peptide to improve cell permeability. The discovery of the first small molecule PROTAC and the ...
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Navigating the Bioinformatics Workflow for Whole Exome Sequencing: A Step-by-Step Guide
Next-generation sequencing (NGS), which makes millions to billions of sequence reads at a fast rate, has greatly sped up genomics research. At the moment, Illumina, Ion Torrent/Life Technologies, 454/Roche, Pacific Bioscience, Nanopore, and GenapSys are all NGS platforms that can be used. They can produce reads of 100–10,000 bp in length, enabling sufficient coverage of the genome at a ...
By CD Genomics
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Significance of Diagnostic Enzyme Detection
Serum enzyme tests have been used in clinical practice for a long time, such as increased amylase activity in serum and urine of patients with acute pancreatitis. In the 1930s, some scholars reported that the determination of serum lipase and alkaline phosphatase activities is helpful for the diagnosis of pancreatitis and bone diseases, respectively. After the 1950s, the application of serum ...
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How can Nuvonis help to fight the SARS-CoV-2 pandemics?
At the end of the year 2019, a cluster of severe pneumonia of unknown cause was described in Wuhan (Eastern China) and a SARS-like acute respiratory distress syndrome (ARDS) was noted in these patients. Early in January 2020, sequencing revealed a novel coronavirus (now termed SARS-CoV-2) as the causal factor for the disease designated as COVID-19. The pandemic caused by the virus has unforeseen ...
By Nuvonis
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Indication selection for anti-PDx combination therapy In collaboration with big pharma - Case Study
The Challenge: One of the most common challenges in immuno-oncology is identifying the indications and patient populations that would benefit from a specific therapy, especially on top of Standard of Care (SOC) treatments. Our platform tackled this challenge of indication prioritization and patient stratification for a combination of a specific target (A) with an anti-PDX drug that one of our ...
By CytoReason
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The Future of Quantitative Susceptibility Mapping (QSM) in Clinical Applications
The use of Quantitative Susceptibility Mapping (QSM) is often viewed as incompatible with current standard radiology workflows. Some radiologists or departments may be unaware of its existence or purpose. Despite the skepticism surrounding its viability in a clinical setting, QSM shows great potential in a wide range of clinical applications, particularly for biomarker detection and ...
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SpinTech MRI Earns FDA 510(k) Clearance for Rapid, Quantitative Brain-Imaging Technology
The US Food and Drug Administration (FDA) has given 510(k) clearance to SpinTech MRI’s latest magnetic resonance imaging software device, STAGE (STrategically Acquired Gradient Echo), a post-processing software platform that enables comprehensive, quantitative brain imaging with enhanced visualization in significantly less time than conventional approaches. STAGE allows MRI ...
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The Clinical Data Interchange Standards Consortium welcomes Lifebit as a partner
What is the Clinical Data Interchange Standards Consortium? The Clinical Data Interchange Standards Consortium (CDISC) is a global, not-for-profit organisation that develops data standards across all the healthcare sector. Founded in 1997, over the last 20+ years CDISC has provided guidance on the transformation of clinical data from incompatible into interoperable formats so that it is usable, ...
By Lifebit
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Clinical data standards vs legacy data
Data standards are a feature of many regulated industries, and the pharmaceutical industry is no exception. But we didn’t always have standards to help us collect, analyze and submit data. Even today, some organizations are not utilizing industry or company standards to ensure their study data is collected the same way every time - despite the many benefits of standardization. Why are some ...
By Formedix
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Achieving CDISC compliance in academia
CDISC compliance is mandatory for clinical trial submissions to the US Food and Drug Administration (FDA) and Pharmaceuticals and Medical Devices Agency (PMDA). The academic world is no exception. In fact, many academic institutions must achieve CDISC compliance in order to be granted funding for clinical research. CDISC standards can seem overwhelming, like a whole new language to be understood ...
By Formedix
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What makes decentralisation the future of clinical trials?
With the emergence of COVID-19, Decentralisation of Clinical Trials became necessary to comply with social distancing requirements while carrying out clinical research. Over the past few years, the clinical trial landscape has shifted its focus to patient-centric practices to promote patient engagement. But now as the pandemic is long gone, it is time to reflect on how DCT studies are genuinely ...
By Clinion
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Recursion Pharmaceuticals Puts Strength on Full Display
The drug developer's latest capital raise, a $150 million private placement, comes during a difficult market environment. The strongest companies can raise money in any environment. Recursion Pharmaceuticals (RXRX) - Get Free Report recently raised $150 million in gross proceeds from a private placement of common stock, including half from a single fund that has never before invested in the ...
By Recursion
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How eCOA Improves Patient Experience and Data Quality
With the rising demand for improving patient safety in clinical trials, the adoption of patient-centric solutions is considered the best route to enhance data accuracy and experience automated workflows. This is where eCOA comes into play. In this blog post, we will find out how electronic clinical outcome assessments are helping the clinical trials industry handle the ever-growing list of ...
By Clinion
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Summary of new EU Clinical Trial Regulation
The changes the regulation brings companies need to already be reviewing their current processes, systems and supporting infrastructure for clinical trial applications and operations. They need to do so in every changing regulatory environment where Clinical Trial and related data is being ever more scrutinized. This paper provides a synopsis of the new regulation Insights on timing The ...
By DDi LLC
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Regulatory requirements for annotated CRFs made easy
Creating good quality annotated case report forms (CRFs) takes time and attention to detail. While it can feel overwhelming, it shouldn’t stop you. Annotated CRFs (aCRFs) are a mandatory requirement of the Food and Drug Administration (FDA), and therefore a key submission deliverable for any clinical trial. So, it’s important to understand what regulatory and industry guidelines ...
By Formedix
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A Review of Therapies For Alzheimer's Disease
Alzheimer's disease (AD) is a progressive, irreversible neurodegenerative disease clinically manifested by cognitive impairment, behavioral abnormalities, and social deficits. It is predicted that by 2050, the number of people 65 and older with dementia in the United States could reach 13.8 million. In China, more than 15.07 million elderly people aged 60 or over suffer from dementia, of which ...
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Driving Data-driven Medicine to Advance Personalized Care
Clinical trials are often designed with the participant’s everyday life in mind – trying to gather as much clinically-relevant data in a controlled manner as possible while allowing individuals to live their regular lives. However, it is true that trials are artificial environments, and participants are actively monitored to ensure their safety and to determine the efficacy of a drug ...
By AiCure
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