clinical data Articles
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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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New trends in the management of late radiation morbidity
Currently, no reliable methods and no suitable marker profile exist that could predict radiosensitivity in patients. This paper describes the irradiation response of lymphocytes, fibroblasts and tumour biopsies cultured in vitro, clonogenic survival at 2 Gy (SF2), chromosomal aberrations, and CD4 and CD8 lymphocyte apoptosis. The results, and other accumulating evidence, strongly suggest that ...
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University Students’ Hand Hygiene Practice During a Gastrointestinal Outbreak in Residence: What They Say They Do and What They Actually Do
Published research on outbreaks of gastrointestinal illness has focused primarily on the results of epidemiological and clinical data collected postoutbreak; little research has been done on actual preventative practices during an outbreak. In this study, the authors observed student compliance with hand hygiene recommendations at the height of a suspected norovirus outbreak in a university ...
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UK Imaging Diabetes Study Seeing Diabetes Clearly - Case Study
Prospective observational cohort study with clinical outcomes data collection. Recruiting adult patients with type 2 diabetes (T2DM) and diabetic retinopathy (DR), who lack history of cardiovascular ...
By Perspectum
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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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Robotics startup Vicarious files pre-submission with FDA, fresh from $220M SPAC raise
Vicarious Surgical has filed a pre-submission with the FDA, marking the start of a regulatory process it hopes will lead to a 510(k) application by late 2023. Dive Brief: Vicarious Surgical has filed a pre-submission with the FDA, marking the start of a regulatory process it hopes will lead to a 510(k) application by late 2023. The filing, which Vicarious disclosed in its first quarterly ...
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Vectorious reports positive results from VECTOR-HF I study of V-LAP system
The first clinical data of an implantable heart sensor with remote measurement capacity was presented at the prestigious ESC Heart Failure 2022 Late-Breaking Science event Israel-based Vectorious Medical Technologies announced the positive results from the VECTOR-HF I study of its V-LAP novel wireless system. The first-in-man clinical study was intended to check the safety, ease of use, and ...
By Vectorious
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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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Long-Term Outcomes Following Lumbar Nucleus Replacement
Abstract Background Nucleus replacement devices are designed to replace the native pain-generating lumbar nucleus while preserving the annulus fibrosus, endplates, and natural motion. The DASCOR Disc Arthroplasty Device seemed to perform well clinically but was discontinued in 2009. While there are no commercially available NRDs today, the potential advantages of using such devices have ...
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A Phase 1 Study Investigating the Combination of AFM13 and the Monoclonal Anti-PD-1 Antibody Pembrolizumab in Patients with Relapsed/Refractory Hodgkin Lymphoma after Brentuximab Vedotin Failure: Updated Safety and Efficacy Data
AFM13 is a first-in-class tetravalent, bispecific NK cell engager that binds to CD30 on tumor cells and CD16A on NK cells. By engaging CD16-positive NK cells, AFM13 leads to NK cell-mediated killing of tumor cells.1 Pembrolizumab (Keytruda®) is approved in patients with R/R classical Hodgkin lymphoma as monotherapy. AFM13 showed single agent clinical activity with solid safety profile in a ...
By Affimed GmbH
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Persistent gene editing therapy using LNP-delivered mRNAs
Gene editing technology, represented by CRISPR/Cas9, has greatly accelerated the development of gene therapy, bringing hope to many genetic diseases that otherwise had no cure. In June 2021, Intellia Therapeutics' NTLA-2001, a CRISPR gene editing therapy for the treatment of transthyretin amyloidosis (ATTR) invented by Nobel Laureate Jennifer Doudna, was proven to be safe and effective in a ...
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Keep Your Heart Healthy During the Holidays!
As we prepare for this holiday season, with an extra dose of joy and elation, please keep in mind what overindulgence can do to your heart health, even in a relatively short period of time. You shouldn’t be surprised to learn that during the holiday season, when we not only tend to overindulge the most but also stress levels are typically the highest, there is a 33% increase in heart ...
By BIOLIFE4D
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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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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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Representative structures of FDA-approved ADCs
Since they were originally explored in animal models in the 1960s, antibody-drug conjugates (ADCs) have seen many booms. The initial ADC clinical studies took place in the 1980s, and Mylotarg, the first ADC drug, was approved in 2000. The removal of Mylotarg, however, came as a huge shock to the industry, and it was relaunched in 2017. The launch of a number of clinically and commercially ...
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2019 Year in Review by President & CEO Matt Likens
As we embark on 2020, I find myself reflecting on the incredible growth GT Medical Technologies has experienced during the past year. We are filled with optimism knowing that each milestone along our journey represents new hope for patients with brain tumors. 2019 SCIENTIFIC AND BUSINESS ACHIEVEMENTS Completing our $10 Million Series A financing for commercialization Publishing the ...
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Regeneron’s High Profile Success? Demand for COVID-19 prophylactics – what role for Pichia expression technology to assist access
With Regeneron’s high profile, single-person, single-site, clinical trial proving successful (along with much supporting other clinical data!), will neutralising antibodies surf the second wave? Our COVID-related blogs focus on capacity and cost of making the treatments and understanding opportunities or bottlenecks in large scale provision and new innovations. In this context, we review ...
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OneThree`s Workflow for Predicting Drug Toxicity - Case study
Background OneThree Biotech was born out of the largest precision medicine institute in America with the purpose of decreasing the failure rate of bringing therapeutics to market using biology driven artificial intelligence. Our technology was builtin a lab setting; allowing us to engineer our methodologies around real-world results. While working with major biotech and pharma partners; ...
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Transforming Genomics Through 2022 and Beyond: Spotlight on Brian Longo
A growing number of governments, pharmaceutical companies and research organisations are choosing Lifebit for its secure, cutting-edge platform and visionary team. Lifebit is pleased to spotlight Brian Longo, who has joined as Lifebit’s Executive Strategic Advisor. Responsible for guiding the design and execution of Lifebit’s rapidly scaling operating models and processes, ...
By Lifebit
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