clinical quality Articles
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Why Healthcare Needs to Think Provider Quality Management and Not Just Peer Review
When an adverse event occurs, the immediate priority is to deal with the situation at hand. Move beyond those immediate and reactive issues and the improvement-minded naturally begin to think about causal and contributory factors and their related corrective actions. These typically fall into two key areas: human and system factors. Human Factors Driven by regulatory and accreditation ...
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Learn how to build quality clinical studies faster at PHUSE EU Connect
13th – 16th November 2022 | Booth #8 Are you going to be in Belfast for PHUSE EU Connect on 13th – 16th November? Do you want to learn how to build quality clinical studies faster and easier? Then let’s connect! Chat with our friendly team Just drop by booth #8 at any time during the conference to talk to us about: starting studies from scratch seeing how eCRFs look and ...
By Formedix
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A generic approach to computer-based Clinical Practice Guideline management using the ECA Rule paradigm and active databases
The increasing demand for reduced cost and improved quality of service in healthcare has prompted the call for better management of medical knowledge. The main emphasis has been on knowledge that is acquired through experience and medical research and then formalised into Clinical Practice Guidelines (CPGs). This paper presents a generic approach to CPG information and knowledge management that ...
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Immunostimulants in the prevention of respiratory infections
Immunomodulation promises to be an effective prophylactic and therapeutic modality for chronic and recurrent respiratory infections. As opposed to vaccines, the term Immunostimulant (IS) refers to a compound that produces a state of non-specific immunity. Most IS are oral formulations of bacterial lysates that have been used in clinical practice for decades. One of the main obstacles in the ...
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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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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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Deliver Clinical Trials On Time and Within Budget By Addressing this One Problem
Annual planning is an opportunity to fix this long-standing clinical operations issue At the beginning of many pharma companies’ financial year, an annual planning process occurs. This presents an opportunity for stakeholders to align on short-, mid-, and long-term goals. Clinical stage pharma companies focus on clinical-trial related goals. These include completing ongoing clinical ...
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Ancora Heart Announces Positive Safety and Efficacy Data from Study of First-of-Its-Kind Investigational Heart Failure Therapy
Interim study results from systolic heart failure patients treated with percutaneous therapy designed to improve left ventricular function presented at TCT 2019 Santa Clara, Calif.–September 25, 2019–Ancora Heart, Inc., a company developing a novel therapy to address heart failure, today announced results from an interim analysis of heart failure patients treated in the CorCinch FMR ...
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Targeted Region Sequencing in Human Disease Studies and Clinical Care
Introduction to target region sequencing Since the introduction of Sanger sequencing in 1977, genetic sequencing has been greatly improved with costs simultaneously falling. With the ability to rapidly produce large volumes of sequencing data, next-generation sequencing (NGS) enables researchers to obtain whole genome or targeted regions of samples. Targeted region sequencing is preferred by ...
By CD Genomics
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The Benefits of Decentralized Clinical Trials for Neurology
The COVID-19 pandemic has catalyzed the implementation of decentralized clinical trials in neurology, bringing the immense benefits of clinical trials to light. This industry-wide push towards trial decentralization has emerged as a key element for improving clinical trial efficiency and improving the experience for patients and physicians. By utilizing digital technologies, such as wearables, ...
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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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Importance of Investing in Healthcare and MedTech R&D
Jian Zhang: Technology has always been a vital ally for healthcare. From diagnostic capabilities finding disease earlier to therapies that increase the quality of care, improve clinical efficiency, and lower cost. But healthcare has been slow to adopt technology because innovation can be long, incremental, and path-dependent. This is especially true when examining investment in research and ...
By Noah Medical
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Clinical CRISPR Success Demonstrates Need for Quality Control
The Clinical CRISPR Successes Are Stacking Up. But Where’s the Emphasis on Quality Control? In mid-September, Intellia released some promising data on two of their CRISPR-based therapeutics. These results are a significant milestone for genome editing and validation of its effectiveness in the clinic. However, the safety of CRISPR-based therapeutics has been a major concern and part of a ...
By CRISPR QC
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The Importance of Independent, Third-Party Quality Controls
You probably have not put as much thought into the clinical importance of independent, 3rd party quality control as Dr. Sonntag which is why we would like to share this article with you. As pointed out by Dr. Sonntag, ISO15189 states that, “The use of an independent third-party quality control should be considered either in place of or in addition to the quality control materials ...
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Medical Devices: Structured Content Authoring Saves Time & Reduces Cost
Medical device companies creating technical documentation, clinical / post-marketing reports, labeling and quality documentation with increasing regulations and recent MDR/IVDR compliance in mind may find that their traditional approaches to these types of content may no longer work. The old document-based approach of creating plans/reports continuously and technical documentation does not lend ...
By DDi LLC
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A Paradigm Shift in the Treatment of Venous Thromboembolic Disease
PE is the most common preventable cause of death among hospital patients in the United States. VTE is a leading cause of death and disability worldwide and has the third-highest mortality rate out of any cardiovascular disease, behind myocardial infarctions and stroke. Unlike myocardial infractions and stroke, where mortality has improved considerably, VTE has seen an increase in cases, with no ...
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Increasing the Efficiency of Drug Development with Preclinical Testing Using Human Intestinal Stem Cells
Due to a lack of robust in vivo gut models, animal studies are generally required to evaluate gut toxicity. However, these studies can be lengthy and expensive and may not accurately recapitulate the behavior of the human gastrointestinal tract. Drugs are thus often developed with undesired gut side effects that are not apparent until clinical trials. Organ-on-a-chip models are the closest ...
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Conceptual Considerations for Device-Based Therapy in Acute Decompensated Heart Failure
Abstract Acute decompensated heart failure remains the most common cause of hospitalization in older adults, and studies of pharmacological therapies have yielded limited progress in improving outcomes for these patients. This has prompted the development of novel device–based interventions, classified mechanistically based on the way in which they intend to improve central hemodynamics, ...
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