AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 25, 2023

Regular, short snoozes keep our brains young by preserving volume, a quality linked with healthy cognitive functions and a lower risk of dementia and other diseases.

Genetics 201

Genetics Scientist Clinical Trials Clinical Trials 201

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 13, 2023

If you needed another reminder of just how important quality sleep is to our health and well-being, a new study has linked three specific sleep problems with a change in risk of developing dementia.

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Development Clinical Trials Clinical Trials Clinical Research 177

Outsourcing Pharma

JUNE 14, 2023

CluePoints is continuing to invest in artificial intelligence (AI) and machine learning (ML) they say they want to help clients 'extract every drop of potential from the RBQM-driven interrogation of their own datasets'. It says it recognizes the importance of educating the industry on the value of this approach.

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Regulation Marketing 73

Outsourcing Pharma

SEPTEMBER 27, 2021

The technology is designed to enable connection to any source data system, enabling connectivity in identifying, monitoring, and managing trial risks.

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Trials Clinical Development Development 52

Bio Pharma Dive

JUNE 20, 2023

When developing a new drug product, quality, safety and timing are critical. A CDMO can be a valuable partner to help mitigate risks.

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Production Development Drugs 130

Outsourcing Pharma

JANUARY 26, 2022

A leader from the RBQM solutions specialists offers a preview of his SCOPE 2022 presentation on tools suited to decentralized trial design and management.

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Trials Clinical Development Development 52

Cloudbyz

MAY 15, 2024

The FDA Center for Veterinary Medicine (CVM)’s draft guidance on pharmaceutical development for veterinary medicines outlines a systematic approach to ensure the quality, safety, and efficacy of veterinary drugs. Consistent product quality and compliance with regulatory standards are achieved through meticulous CQA monitoring.

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Compliance Laboratory Information Management System Clinical Trials Clinical Trials 52

XTalks

MAY 2, 2024

With seamless access to integrated data from different sources, you can provide your teams with a complete data management and quality experience. Understand how using AI to streamline workflows for multiple users to review real-time data can reduce timelines and risk and ensure safety.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Life Science 52

Pharmaceutical Technology

JUNE 21, 2023

LODOCO is indicated for reducing the risk of stroke, myocardial infarction and cardiovascular death in adults with established atherosclerotic cardiovascular disease (ASCVD) or with multiple risk factors for the disease. AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5

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FDA Approval Cardiology Clinical Trials Clinical Trials 246

Outsourcing Pharma

SEPTEMBER 27, 2021

The technology is designed to enable connection to any source data system, enabling connectivity in identifying, monitoring, and managing trial risks.

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Trials Clinical Development Development 52

BioPharma Reporter

MAY 10, 2022

The US FDA released new draft guidance yesterday discussing, among other challenges, how unresolved product quality issues might be addressed in the context of regulatory decision-making.

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Production Drugs Regulation Marketing 52

Forte Research Systems®

JULY 28, 2020

This article breaks down risk-based monitoring, as well as other data protection terms falling underneath it. Protecting participant data is of the utmost importance in clinical research.

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Clinical Research Research 52

Scienmag

JANUARY 21, 2021

Scientists conducted a sweeping review of nature’s contributions to humans in order to present a clear breakdown of global trends since 1970. Not surprisingly, the results are grim Credit: Brauman et al. 2020) It is no secret that over the last few decades, humans have changed nature at an ever-increasing rate.

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Scientist Production Development Medicine 52

Outsourcing Pharma

NOVEMBER 21, 2023

CluePoints, a company providing risk-based study execution (RBx) and risk-based quality management (RBQM) software for clinical trials has won the best Contract Research Organization (CRO) in the specialist providers category at Citelineâs 2023 SCRIP Awards.

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Clinical Trials Clinical Trials Trials Research 81

Outsourcing Pharma

AUGUST 4, 2023

Risk-based quality management (RBQM) is used to identify and assess risks then finding ways to manage them and is an important part of clincal trials.

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Trials Research 82

Cloudbyz

APRIL 8, 2024

One of the most significant challenges in conducting clinical trials is ensuring data quality and patient safety while managing costs effectively. Enter Risk-Based Monitoring (RBM), a paradigm shift in the world of clinical trials. Traditional, one-size-fits-all monitoring approaches have limitations in addressing these concerns.

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Clinical Trials Clinical Trials Trials Development 74

Worldwide Clinical Trials

APRIL 25, 2024

The intricacies of post-surgical pain studies necessitate innovative approaches to data collection, where the subjective and fluctuating nature of pain can significantly impact the quality of data gathered. The CAT team takes it further by providing accessible scale management support to assure quality data.

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Clinical Trials Clinical Trials Compliance Trials 130

Medical Xpress

DECEMBER 2, 2022

In the older European population, men, as well as those with lower socioeconomic status, weak social ties, and poor health, might experience more difficulties getting informal support and are considered to have a higher risk of worsening frailty state and lower quality of life.

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Doctors Doctor Research 142

Pharmaceutical Technology

MAY 15, 2023

This common menopausal symptom is disruptive to women’s quality of life and activities, states an Astellas release. This includes an increased risk of heart attack, stroke, and breast cancer, amongst others, per the US National Institutes of Health’s National Institute on Aging.

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Hormones FDA Approval Licensing Licensing 244

Medical Xpress

MAY 2, 2023

Exercise decreases the risk of cancer and reduces side effects of cancer treatments. In addition, it improves patients' quality of life and the prognosis of cancer patients. This is according to two new Finnish studies.

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Medical Xpress

APRIL 3, 2023

Poor quality sleep may bolster a person's genetic susceptibility to asthma, potentially doubling their risk of being diagnosed with the condition, suggests a large UK Biobank study, published in BMJ Open Respiratory Research.

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Genetics Biobanking Research 98

Medical Xpress

APRIL 21, 2023

A high-quality diet that minimizes red meat and processed foods is linked with lower risks of heart attack and stroke in patients with cardiovascular disease, according to a study published today in the European Journal of Preventive Cardiology.

Cardiology 97

Cardiology 97

Medical Xpress

JANUARY 23, 2023

For teens at elevated risk of developing alcohol use disorder (AUD), close relationships with parents can mitigate their genetic and environmental vulnerability, a new study suggests. Increasing evidence suggests that this heritable risk may be either amplified or mitigated by the quality of parenting.

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Development Genetics 86

Medical Xpress

MARCH 28, 2023

Losing weight with lifestyle changes in an intensive behavioral weight loss program was associated with a decrease in risk factors for cardiovascular disease and Type 2 diabetes for at least five years—even if some weight was regained, according to a systematic review of research, published today in Circulation: Cardiovascular Quality and Outcomes. (..)

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Research Cardiology 96

Medical Xpress

FEBRUARY 23, 2023

Preoperative surgeon intuition is an independent predictor of 30-day postoperative complications; however, when compared to the standard risk calculator derived from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP), its predictive power isn't as strong, according to a study published in the Journal of the American (..)

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Cloudbyz

MAY 5, 2023

Executive Summary Risk-Based Monitoring (RBM) is an approach to clinical trial monitoring that optimizes the use of resources by focusing on trial risks, with the goal of ensuring patient safety, data quality, and regulatory compliance. Methodology of Risk-Based Monitoring 4.1. Benefits of Risk-Based Monitoring 5.1.

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Clinical Trials Clinical Trials Trials Compliance 76

Pharmaceutical Technology

MARCH 17, 2023

According to Pharmanovia, AGHD affects two to three people in 10,000 with significant morbidity risk and reduced quality of life. The company stated that the new licensing agreement expands its existing endocrinology portfolio.

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Hormones Licensing Licensing Medicine 263

Scienmag

APRIL 26, 2022

Genetic risk factors and diet quality are independently associated with type 2 diabetes; a healthy diet is linked to lower diabetes risk across all levels of genetic risk.

Genetics 82

Genetics Medicine 82

Cloudbyz

MAY 17, 2024

Key Impacts on Clinical Trials Increased Regulatory Scrutiny The AI Act mandates strict requirements for “high-risk” AI systems, such as those used in clinical trials, including clinical decision support software and patient monitoring systems.

Life Science 52

Life Science Clinical Trials Clinical Trials Trials 52

Medical Xpress

MAY 14, 2023

Hot flashes, night sweats and sleep disturbances are common symptoms of menopause that can affect health, quality of life and work productivity.

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Hormones Production 88

Medical Xpress

APRIL 20, 2023

Good-quality running gear, such as the right pair of shoes, is vital to improve running performance and reduce injury risk. Running is one of the most accessible forms of exercise with an array of proven cardiovascular and musculoskeletal benefits, and an added bonus of increased mental health.

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Medicine 98

FDA Law Blog

NOVEMBER 29, 2023

Guiding Principle 10 focused on monitoring the performance of the models and managing re-training risks. Five guiding principles were identified for PCCPs and relate to being focused, risk-based, evidence-based, transparent, and taking into consideration total product lifecycle management.

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Development Manufacturing Production Regulation 115

Pharmaceutical Technology

JULY 25, 2022

Digital technologies will be utilized throughout drug development, production, packaging and delivery for increased process efficiency and improved product quality. Along the way, the company hopes to find new possibilities to transform its manufacturing processes and improve product quality. Disruptive technologies.

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Engineer Packaging Packaging Production 286

Pharma Mirror

FEBRUARY 14, 2022

Human activities pose numerous risks to the environment, so many industries and sectors are looking to become more sustainable. Can medical labs switch to greener practices without affecting the quality and accuracy of their output? The concept of sustainability is gaining more traction in society with each passing day.

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CTTI (Clinical Trials Transformation Initiative)

DECEMBER 12, 2023

Presentation: Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) Approaches Date: Wed., 31, 9:00 a.m. – 4:20 p.m.

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Medical Xpress

DECEMBER 27, 2022

Regular, high-quality sleep habits help children consolidate memory and learn better. A lack of sleep contributes to childhood depression, anxiety and even risk of suicide, along with physical health problems, including risk of injury. The challenge is making sure kids log those valuable zzz's.

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Medical Xpress

DECEMBER 10, 2022

For example, children with a so-called Ikaros change in the DNA of their leukemia cells have a greater risk of their disease coming back after treatment. But some children have a more aggressive form of the disease.

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DNA 119