Human subject research

New Study Shows GlycoMark® Test Identifies Prediabetic Individuals with the Highest Risk of Developing Diabetes Before Symptoms Develop

Retrieved on: 
Tuesday, February 21, 2023
Metabolomics, Physician, Journal, 1,5-Anhydroglucitol, Endocrine Society, Type 2 diabetes, Insulin, Human subject research, Functional, Patient, Shen, Cell, University, Prediabetes, Risk, University of Geneva, Pancreas, Phenotype, Public, Fasting, Metabolism, Pharmaceutical industry, Arginine, Diabetes

A functional beta-cell mass biomarker is essential to identify which prediabetic individuals have the highest risk of progression to diabetes.

Key Points: 
  • A functional beta-cell mass biomarker is essential to identify which prediabetic individuals have the highest risk of progression to diabetes.
  • Type 2 diabetes can take years to develop, and if caught early, it is an entirely preventable disease.
  • Unfortunately, it is not possible with current diabetes tests such as hemoglobin A1C and fasting glucose to identify with an acceptable degree of certainty which prediabetic individuals have the highest risk of progression.
  • As the GlycoMark test reflects a progressive decline of functional beta-cell mass, it can identify prediabetic patients with the highest risk of developing diabetes before the first symptoms develop.

New Study Shows GlycoMark® Test Identifies Prediabetic Individuals with the Highest Risk of Developing Diabetes Before Symptoms Develop

Retrieved on: 
Tuesday, February 21, 2023
Metabolomics, Physician, Journal, 1,5-Anhydroglucitol, Endocrine Society, Type 2 diabetes, Insulin, Human subject research, Functional, Patient, Shen, Cell, University, Prediabetes, Risk, University of Geneva, Pancreas, Phenotype, Public, Fasting, Metabolism, Pharmaceutical industry, Arginine, Diabetes

A functional beta-cell mass biomarker is essential to identify which prediabetic individuals have the highest risk of progression to diabetes.

Key Points: 
  • A functional beta-cell mass biomarker is essential to identify which prediabetic individuals have the highest risk of progression to diabetes.
  • Type 2 diabetes can take years to develop, and if caught early, it is an entirely preventable disease.
  • Unfortunately, it is not possible with current diabetes tests such as hemoglobin A1C and fasting glucose to identify with an acceptable degree of certainty which prediabetic individuals have the highest risk of progression.
  • As the GlycoMark test reflects a progressive decline of functional beta-cell mass, it can identify prediabetic patients with the highest risk of developing diabetes before the first symptoms develop.

Medable Unifies and Simplifies Consent Management for Global Decentralized and Hybrid Trials

Retrieved on: 
Thursday, November 3, 2022
Software, Biotechnology, Pharmaceutical, Internet, Health, Data Management, Technology, Clinical Trials, Institutional review board, Compliance, Time, General manager, Multimedia, Industry, COVID, Geography, FDA, Software as a service, Clinical, Knowledge, Cros, Human subject research, Clinical trial, IDC, Patient, BLS digital signature, Efficiency, Pharmaceutical industry

View the full release here: https://www.businesswire.com/news/home/20221103005495/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20221103005495/en/
    Clinical trials face enormous hurdles around patient recruitment and retention, including lengthy, convoluted consent processes that often leave patients confused or discouraged.
  • Many trials run in multiple countries simultaneously and regulations around eConsent vary dramatically across the globe, adding to the complexity.
  • This SaaS offering allows patients to consent onsite or remotely, with eSignature or wet ink signature.
  • And, as with all its SaaS offerings, Medable provides Total Consent customers with in-depth training to enable faster deployment of eConsent across their trials including a new rapid onboarding option.

National Association for Healthcare Quality (NAHQ) Launches Groundbreaking Research on Why Competency Standardization Matters for Healthcare Improvement

Retrieved on: 
Wednesday, September 1, 2021
Nursing, General Health, Health, Continuing, Hospitals, Education, Training, Other Health, Certification, Population, Journal, University, Health care, Associate, Population health, Patient safety, Research, Editing, Lead, Health, Accreditation, Journal for Healthcare Quality, Certified Professional in Supply Management, Human subject research, Goal, CEO, National Association, Organization, Birmingham School, Institutional review board, Workforce, DeLisi, Medicine, Medical device, Management, Healthcare

Today, the National Association for Healthcare Quality ( NAHQ ), the only organization dedicated to healthcare quality professionals, announces its groundbreaking research describing the critical work of healthcare quality professionals: Why Competency Standardization Matters for Improvement: An Assessment of the Healthcare Quality Workforce .

Key Points: 
  • Today, the National Association for Healthcare Quality ( NAHQ ), the only organization dedicated to healthcare quality professionals, announces its groundbreaking research describing the critical work of healthcare quality professionals: Why Competency Standardization Matters for Improvement: An Assessment of the Healthcare Quality Workforce .
  • This peer-reviewed research published today, September 1, 2021, in the Journal for Healthcare Quality is based on nearly 1,700 responses to NAHQs Professional Assessment survey, a standardized tool for healthcare quality professionals to self-assess the work they do across the twice-validated Healthcare Quality Competency Framework, and it is the first-ever database that describes healthcare quality workforce readiness to advance quality and safety goals.
  • Todays healthcare leaders need to understand the broad scope of work encompassed by the healthcare quality professionals role and recognize the need to reduce variability within the healthcare quality workforce, said Stephanie Mercado, CEO and Executive Director of NAHQ, who led the development of the Healthcare Quality Competency Framework.
  • We offer the only accredited certification in healthcare quality, the Certified Professional in Healthcare Quality (CPHQ), extensive educational programming, networking opportunities and career resources to help healthcare quality professionals enhance their competencies and their value.

Censinet Delivers First Healthcare Industry Cybersecurity Risk Assessment Workflows for Research & Institutional Review Boards

Retrieved on: 
Tuesday, June 29, 2021
Technology, Medical devices, Insurance, Hospitals, Security, Professional services, Software, General Health, Health, Data management, Articles, Ethics, Academic disciplines, Design of experiments, Human subject research, Institutional review board, Regulatory compliance, Social research, UST

Censinet , the leading provider of healthcare IT risk solutions, today announced a significant expansion of its Censinet RiskOps platform with the formalized introduction of intelligence and workflows that address the cybersecurity requirements of healthcare research, including research overseen by an Institutional Review Board (IRB).

Key Points: 
  • Censinet , the leading provider of healthcare IT risk solutions, today announced a significant expansion of its Censinet RiskOps platform with the formalized introduction of intelligence and workflows that address the cybersecurity requirements of healthcare research, including research overseen by an Institutional Review Board (IRB).
  • Our laser focus on healthcare enables us to continually deliver industry-driven solutions that general-purpose risk solutions just cant.
  • In the too infrequent event that a cybersecurity risk assessment is done for research, its likely using the same antiquated spreadsheet methods now superseded by Censinet RiskOps.
  • For research and IRBs, Censinet RiskOps for Research & IRB help assess and manage the cybersecurity risk to a hospital system's sharing PHI with researchers.

Update On IGC’s Phase 1 Clinical Trial on Alzheimer’s Patients

Retrieved on: 
Monday, February 22, 2021
Alternative medicine, FDA, Health, Clinical trials, General Health, Pharmaceutical, Health sciences, Clinical research, Medical research, Articles, Clinical trials, Inclusion and exclusion criteria, Human subject research, Informed consent, Pharmaceutical industry

Enrolling patients and commencing the trial involves obtaining Informed Consent, conducting neurological exams, and conducting initial blood tests, among others, to identify inclusion and exclusion criteria to ensure that patients meet the enrollment requirements.

Key Points: 
  • Enrolling patients and commencing the trial involves obtaining Informed Consent, conducting neurological exams, and conducting initial blood tests, among others, to identify inclusion and exclusion criteria to ensure that patients meet the enrollment requirements.
  • A Phase 1 trial is the first human trial in a multi-step process designed to obtain regulatory approval for the marketing of a new pharmaceutical drug.
  • The Phase 1 trial is conducted and managed by IGCs subsidiary, IGC Pharma LLC.
  • These forward-looking statements are based largely on IGCs expectations and are subject to several risks and uncertainties, certain of which are beyond IGCs control.

Ethics Approval Granted for Open Orphan’s COVID-19 Human Challenge Study Model

Retrieved on: 
Wednesday, February 17, 2021
Biotechnology, Infectious diseases, Health, Pharmaceutical, Clinical trials, Health sciences, Health, Medicine, Medical research, Occupational safety and health, Human challenge study, Human subject research, COVID-19 vaccine, Vaccine, Coronavirus disease, Open Orphan, Health Research Authority

This news follows the announcement on October 20, 2020 of Open Orphan subsidiary hVIVOs contract with the UK Government to develop a COVID-19 human challenge study model.

Key Points: 
  • This news follows the announcement on October 20, 2020 of Open Orphan subsidiary hVIVOs contract with the UK Government to develop a COVID-19 human challenge study model.
  • This study is a key enabling study to establish the COVID-19 challenge model and determine the lowest possible dose of virus required.
  • Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD.
  • In addition, Open Orphan is also developing the worlds first COVID-19 human challenge study model as part of the Human Challenge Programme and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge studies.

AXEL Hosts Free Continuing Legal Education (CLE) Ethics Course for the Legal Industry

Retrieved on: 
Thursday, February 11, 2021
Articles, Ethics, Applied ethics, Clinical research ethics, Human subject research, Medical ethics, Legal professions, Ethics committee, Lawyer, Reciprocity

In particular, the legal industry has seen this the most, as law practices and legal service providers have had to make significant changes with the ongoing trend of working remotely.

Key Points: 
  • In particular, the legal industry has seen this the most, as law practices and legal service providers have had to make significant changes with the ongoing trend of working remotely.
  • Participants will include in-house counsel, independent attorneys and related professionals to discuss how to effectively meet the legal community's ethics needs, and address the legal and ethical concerns of working remotely.
  • As state bars and ethics committees continue to weigh in, attorneys need to be aware of the latest concerns and solutions."
  • This one-hour webinar is approved for 01.00 ethics credit in four states, with reciprocity eligibility in eight others.

I Peace, Inc. Obtains IRB Approval for Production of Clinical and Research-Grade iPSCs for Commercial Use

Retrieved on: 
Thursday, December 3, 2020
Clinical research, Health, United States Public Health Service, Medical research, IPSCS, Human subject research, Food and Drug Administration

In accordance with FDA regulations, an IRB is a group that has the authority to approve, require modifications (to secure approval), or disapprove study protocols, informed consent forms, and other related documents.

Key Points: 
  • In accordance with FDA regulations, an IRB is a group that has the authority to approve, require modifications (to secure approval), or disapprove study protocols, informed consent forms, and other related documents.
  • This group review serves an important role in the protection of the rights and welfare of human research subjects, according to the FDA.
  • This allows research institutions and companies to use our iPSCs for clinical research with confidence.
  • I Peace's state-of-the-art GMP facility and proprietary manufacturing platform enables the fully-automated mass production of discrete iPSCs from multiple donors in a single room.

New Light Technologies and Econometrica Team Win New Contracts with the U.S. Census Bureau to Develop Next-Generation Statistical Data Products and Disclosure Avoidance Solutions

Retrieved on: 
Monday, October 12, 2020
Privacy, Disclosure, Human subject research, Statistical disclosure control, United States Census, Data visualization, Information, Visualization, Articles, Academic disciplines

NLT, who brings many years of experience building large-scale public statistical data products and who has developed award-winning web-based data visualization and dissemination applications for the bureau, will lead the delivery of contracted services.

Key Points: 
  • NLT, who brings many years of experience building large-scale public statistical data products and who has developed award-winning web-based data visualization and dissemination applications for the bureau, will lead the delivery of contracted services.
  • The team will focus ondeveloping new economic data products and analytical tools for examining labor market activity and business productivity measures over time andimplementing state-of-the-art disclosure avoidance solutions including the 2020 Decennial Census Disclosure Avoidance System (DAS) that protects personally identifiable information (PII) in statistical data across the bureau.
  • The team will also provide comprehensive research, programmatic, and IT support for large data computing infrastructures that serve the nation's statistical community including the Federal Research Data Centers (FRDCs).
  • Since its founding in 1998, Econometrica has been involved in complex, high-profile contracts for organizations including the U.S. Census Bureau; U.S.