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Clinical Quality Articles & Analysis
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Food and Drug Administration (FDA), further reinforcing the platform’s safety, reliability, and clinical value in modern radiation oncology. According to the official SFDA authorization document, RTsafe is authorized to market its patient-specific pre-radiotherapeutic end-to-end verification devices in the Kingdom enabling comprehensive end-to-end verification of ...
ByRTsafe
This achievement highlights Huateng Pharma’s dedication to meeting the highest regulatory standards and further strengthens its commitment to supporting the pharmaceutical industry’s research and clinical needs. The successful DMF filing demonstrates that Huateng Pharma’s production processes and quality control systems fully comply with FDA ...
Caresyntax, the leading vendor of enterprise-scale data-driven surgical intelligence solutions to make surgery safer and smarter, today announced its highlights and achievements of 2023, as the company has continued its strong growth journey. Dennis Kogan, co-founder, and CEO: “Caresyntax celebrated its 10-year anniversary in 2023 and accelerated our journey of innovation and expansion ...
Caresyntax, the leading vendor-neutral surgical data and intelligence platform converging AI-powered software, devices, and clinical services, today announced the launch of Caresyntax Clinical Data as a Service (CDaaS) for Medtech industry partners. ...
Their unique technology as well as high quality bioink, provide revolutionary capabilities to the wider life science and drug discovery market. ...
ByCELLINK
With more than 60 years’ expertise in respiratory diagnostics, Vitalograph is the only company in the world specialized in delivering clinical trial services exclusively for pulmonary function-focused studies. Speaking about the recent additions to their portfolio of services, Richard James, Executive Vice President and Chief Operating Officer of Vitalograph Clinical Trials says: ...
Would you like to achieve good governance in your service through demonstrating continuous quality improvement? Join our next webinar 'QCS Audit Masterclass: How to use audit effectively' Date: 7th September Time: 1:00pm - 2:00pm To achieve good governance in your service you must demonstrate continuous quality improvement. ...
The Covid-19 epidemic has changed the world in many ways, and many clinical trials have been done to research more about it. According to the World Health Organization (WHO), 12,969 clinical trials were done in America in 2021. Even in pre-pandemic times, clinical trials have always been an ongoing process. ...
In addition, NCQA manages the evolution of HEDIS, the healthcare quality measurement tool used by more than 90 percent of health plans in the United States, covering 200 million people. This certification allows ApolloMed to provide services that align with the industry's most rigorous clinical quality measurement processes, resulting in more ...
iRhythm Technologies will have the results of four studies presented by leading clinical investigators at the American Heart Association’s 2022 Scientific Sessions on Nov. 5-7 in Chicago, Illinois. ...
Remote assessments can relate to symptoms, functional outcomes, or side effects of medications, and enable more timely and accurate self-reporting while also preventing potential recall bias.1 The use of ePROMs has been shown to improve medication adherence, clinical effectiveness, quality of life, and long-term survival rates.2 For example, in a study by ...
ITM-11 is being evaluated as a Targeted Radionuclide Therapy in two phase III clinical trials, COMPETE and COMPOSE. The FDA Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address an unmet medical need. ...
Betty Polikar, Gianluca De Danieli, Pietro Bubba Bello and Gaia Bisaccioni strengthen the Clinical Research, Manufacturing and Quality areas BetaGlue Technologies has appointed four new managers, strengthening the team across strategic fields for its business development: Betty Polikar, Gianluca De Danieli, Pietro Bubba Bello and Gaia Bisaccioni joined ...
Betty Polikar, Gianluca De Danieli, Pietro Bubba Bello and Caia Bisaccioni strengthen the Clinical Research, Manufacturing and Quality areas Clinical developments continue on the advanced cancer radiotherapy platform, BAT-90, as the first breast cancer patient was treated Milan, October 19, 2022 - BetaGlue Technologies, a highly innovative ...
Endpoint Clinical, the leader in global interactive response technology (IRT®) for clinical trials, and Egnyte, the secure platform for content collaboration and governance, today announced that Endpoint Clinical has partnered with Egnyte, providing a Google Cloud-compliant platform to establish a secure file server that can share IRT audit ...
This clearance further validates the quality and clinical efficacy of the company’s artificial intelligence (AI)-powered precision imaging and analytics solutions. ...
In 2020, she founded Fabrica Consulting LLC, a medical device consulting firm providing global regulatory and clinical trial strategies, where she currently serves as president. Prior to this, she was at Elixir Medical Corporation for nearly 12 years, where she held several executive positions including President of New Therapies and Chief Regulatory Officer and Executive Vice ...
ByTISSIUM
Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, and Provation, the premier software and SaaS provider of clinical productivity and workflow automation solutions, announced today that SKOUT™ has received 510(k) clearance from the U.S. ...
Patients with mild OSA are more likely to report poor quality of life compared to controls, after adjusting for confounders including age, gender, ethnicity, marital status, smoking, education, and co-morbidities.5 In addition, epidemiological analyses have found compared with controls, patients with mild OSA have a 224% increased risk of developing hypertension6, are 83% more ...
DEFIANCE is a randomized controlled trial (“RCT”) comparing the clinical outcomes of patients with iliofemoral deep vein thrombosis (“DVT”) treated with the ClotTriever System versus anticoagulation only. ...