clinical regulations Articles
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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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What’s new in Balance Software ´21 version?
A completely redesigned version, PhysioSensing Balance Software´21 was already released, after a long journey of new developments and software improvements. PhysioSensing Balance Software´21, after 10 years of development and experience, is now a powerful balance software analysis tool. We are updating it to all our clients. In this version, you can find: A newdesign, that allows ...
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Commissioning of an ultra-high dose rate pulsed electron beam medical LINAC for FLASH RT preclinical animal experiments and future clinical human protocols - Case Study
Purpose To present the acceptance and the commissioning, to define the reference dose, and to prepare the reference data for a quality assessment (QA) program of an ultra-high dose rate (UHDR) electron device in order to validate it for preclinical animal FLASH radiotherapy (FLASH RT) experiments and for FLASH RT clinical human protocols. ...
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Focus On These 4 Things to Accelerate Clin Ops Productivity
Whether your clinical operations team sits in a large sponsor company, or in one that’s still growing, it must be supported by efficient systems to maintain high productivity. Clinical trial protocols must be conducted with quality, within budget, and within timelines. To achieve this, Clinical Program Managers and their teams must be able to rely on 4 things: A strong ...
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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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MRE associated with increased risk of cardiovascular disease in patients with NAFLD - Case study
A new study was published in March of 2021 demonstrating that elevated liver stiffness, as measured by magnetic resonance elastography (MRE), is associated with higher rates of cardiovascular disease in patients with non-alcoholic fatty liver disease (NAFLD). As clinical researchers, regulators and pharmaceutical partners pursue noninvasive biomarkers to replace liver biopsy, links to adverse ...
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Matrix Gemini Lims at work in Cancer research trials case study
Executive Summary The Roy Castle Lung Cancer Foundation (RCLCF) is a UK wide charity, dedicated to the defeat of lung cancer. It funds basic science research, tobacco control initiatives and work in lung cancer patient information, support and advocacy. RCLCF works towards defeating lung cancer through research, campaigning and education and gives practical and emotional support for patients and ...
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Top 9 Questions about Using NovoSorb BTM in a Clinical Setting
Whether you are a first-time user or an expert in NovoSorb BTM (Biodegradable Temporizing Matrix) for dermal repair and reconstruction, we’re here to answer questions you may have regarding its use in a clinical setting. Below is a list of questions we get asked the most regarding the use of NovoSorb BTM. 1. Can NovoSorb BTM Be Applied with a Graft in a One-Stage Procedure? NovoSorb BTM ...
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Latest data on the safety and effectiveness of COVID-19 vaccines in children
Childhood vaccinations provide immunity to children against serious infectious diseases before they are exposed to them to prevent illness. Many childhood diseases, such as smallpox and polio, have been almost completely eradicated as a result of widespread, standardized childhood vaccination programs. Some vaccinations, such as those for highly contagious diseases including measles, mumps, ...
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Biorep Innovation Partner to COVID-19 Stem Cell Therapy Trial
After a lightning round of proposals and reviews, an international team of scientists led by Dr. Camillo Ricordi was granted immediate FDA authorization for a 24-patient clinical trial to test the safety and exploratory efficacy of umbilical cord-derived mesenchymal stem cells (UC-MSCs) to block the life-threatening lung inflammation that accompanies severe cases of COVID-19. The therapy uses ...
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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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Mortuary Management using Matrix tracker case study
The Ashford and St Peter's NHS Trust in the UK has chosen Matrix Tracker to manage and track the transition of bodies through the hospital mortuary. Organisation Ashford and St. Peter's Hospitals NHS Trust was formed in April 1998 and manages two sites; Ashford Hospital in Middlesex and St. Peter's Hospital in Chertsey, Surrey. The mortuary at Ashford and St Peters Hospital (ASPH) is an ...
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The Netflix of Digital Biology? Recursion Is Reimagining Drug Discovery
By applying a proprietary operating system to drug discovery, the Utah clinical-stage biotechnology company expects to turn drug discovery from sequential testing into a search problem. Unmet clinical needs often serve as the fundamental driving force behind drug discovery programs. During lead discovery, an intensive search ensues to find a drug-like small molecule or biological therapeutic, ...
By Recursion
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