Rethinking Clinical Trials

JULY 10, 2023

In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee Meeting in May, Keith Marsolo, PhD, Co-Chair of the Electronic Health Records Core , reflected on data sharing experiences from the program and factors affecting the meaningful re-use of data. Most studies have only had one or two requests for data.

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Worldwide Clinical Trials

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. We act as an extension of your team, cultivating an open and transparent environment.

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Clinical Development Clinical Trials Clinical Trials Trials 333

Rethinking Clinical Trials

JANUARY 31, 2023

The authors suggest that for data to be useful for new generative science or for reproducibility, the NIH should provide guidance regarding 5 important questions: What data should be shared and for what purpose? What are the immediate and ongoing resources needed to support data sharing? What do we mean by reproducibility?

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Rethinking Clinical Trials

NOVEMBER 16, 2022

Ethics, Data Sharing, Pragmatic Clinical Trials. As one of the federal departments and agencies with the largest research and development budget, the NIH came out with one of the first federal data sharing policies in 2003 called the NIH Data Sharing Policy and Implementation Guidance. Key Points. Two takeaways: 1.

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Clinical Trials Clinical Trials Trials Research 246

Pharmaceutical Technology

JULY 21, 2022

With predictive analytics, AI provides increased visibility of supply chains, improving transparency around costs, logistics, warehousing, and inventory. Data are collected from each stage and then analysed by AI algorithms to increase efficiency and productivity.

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FDA Approval Pharma Companies Drugs Clinical Trials 245

Rethinking Clinical Trials

JULY 12, 2023

Stephanie Morain At the NIH Pragmatic Trials Collaboratory Steering Committee’s annual meeting in May, Dr. Stephanie Morain discussed the results of a recent bioethics initiative to explore ethical considerations for data sharing in the context of pragmatic clinical trials.

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Trials Clinical Trials Clinical Trials Research 130

World of DTC Marketing

AUGUST 3, 2020

QUICK READ: As COVID-19 vaccines enter Phase III trials one has to wonder just how transparent pharma companies will be with the data. In fact, some companies are playing games with the data endpoints. Will we have transparent data around test versus control groups?

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Vaccination Vaccine Immune Response Pharma Companies 155

ACRP blog

OCTOBER 24, 2023

While feedback from clinical trial participants that they would like their personal study data and overall trial results to be shared with them has been loud and clear for many years now , effective follow-through from sponsors and sites on such sentiments has historically been more muddled. Among the nonprofit TransCelerate BioPharma Inc.’s

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Trials Clinical Trials Clinical Trials Clinical Research 59

Drug Discovery World

JANUARY 29, 2024

The event highlighted critical areas such as secure and diverse data access, genomic sequencing in newborns, building public trust, and global collaboration, setting the stage for transformative developments in precision medicine. Involving the public to earn and strengthen trust: Building trust in secure data use is paramount.

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Genome Genomics Medicine Biobanking 59

Rethinking Clinical Trials

MAY 10, 2023

Denny, MD, MS CEO, All of Us Research Program Slides Keywords Precision Medicine, All of Us Research Program Key Points The mission of the All of Us Research Program is to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us. .;

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Medicine Research Clinical Trials Clinical Trials 130

ACRP blog

OCTOBER 24, 2023

While feedback from clinical trial participants that they would like their personal study data and overall trial results to be shared with them has been loud and clear for many years now , effective follow-through from sponsors and sites on such sentiments has historically been more muddled. Among the nonprofit TransCelerate BioPharma Inc.’s

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Trials Clinical Trials Clinical Trials Clinical Research 52

Roots Analysis

AUGUST 17, 2023

In recent years, blockchain has garnered significant interest of researchers, as well as industry players, as it has proven to be a versatile tool for decentralized monetary transactions and data exchange in various industries, such as banking, cyber security, supply chain management, government and healthcare.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Marketing 52

Cloudbyz

SEPTEMBER 16, 2023

Addressing data privacy and data protection concerns when implementing ChatGPT in clinical trial operations management is crucial to maintain compliance with regulations, safeguard sensitive patient information, and build trust among stakeholders. This may involve conducting regular audits and assessments to maintain compliance.

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Clinical Trials Clinical Trials Trials Compliance 59

Drug Discovery World

AUGUST 29, 2023

The pharmaceutical industry continues to maintain strong levels of public trust and favourability in the UK, according to data from the Association of the British Pharmaceutical Industry (ABPI). Four in five believed companies invested in high quality research using cutting edge technology.

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Doctors Doctor Medicine Research 98

Cloudbyz

OCTOBER 4, 2023

Electronic Data Capture (EDC) systems are widely used in clinical trials to collect, manage, and analyze data from clinical studies. While EDC systems primarily focus on data capture and management, integrating trial budget management software within the EDC system can offer several advantages: 1.

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Clinical Trials Clinical Trials Trials Compliance 88

Rethinking Clinical Trials

APRIL 10, 2023

The research team will contribute weighted average effect estimands to quantify treatment effect evidence by recognizing that unequal cluster sizes may contribute to variations of treatment effects in each cluster-period. Li is an assistant professor of biostatistics at the Yale School of Public Health.

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ACRP blog

JANUARY 30, 2024

“We’re seeing significant innovations in the medical product development industry, and true innovation can cause some consternation in such a highly regulated sector,” says David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, at the U.S. View complete schedule.

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Trials Clinical Trials Clinical Trials Clinical Research 59

BioTech 365

JULY 21, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: AbbVie, Roche top data transparency list, but more could be done to build trust in medical system: report.AbbVie, Roche top data transparency list, but more could be … Continue reading →

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Research 40

pharmaphorum

JANUARY 25, 2021

The clinical research community has been disrupted in a number of ways due to COVID-19 and sparked a spirit of collaboration and innovation. Worldwide Clinical Trial’s Aman Khera gives five predictions of how clinical research could change in 2021. Prediction 1: Increased transparency and accountability. public education.

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Clinical Research Research Clinical Trials Clinical Trials 123

Cloudbyz

MAY 15, 2023

As such, the integrity of data collected during these trials is paramount. Below, we explore some practical strategies to improve data integrity in clinical trials. Implementing Standard Operating Procedures (SOPs) SOPs are foundational to ensuring data integrity.

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Clinical Trials Clinical Trials Trials Compliance 68

Rethinking Clinical Trials

JANUARY 31, 2024

DIHI built a modular infrastructure to support many projects via a flexible data pipeline technology infrastructure that started with one model and now includes dozens of models. – How do you get reliable information and data for care that is received outside of Duke? How do you mitigate bias because of incomplete data?

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Production Development Clinical Trials Clinical Trials 161

Cloudbyz

SEPTEMBER 19, 2023

Introduction Clinical research is a complex and highly regulated field where meticulous attention to detail is paramount. Traditional methods of manual data entry and study build are not only resource-intensive but also prone to human errors. Accuracy and Consistency : Human errors are a significant concern in manual data extraction.

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Compliance Clinical Trials Clinical Trials Clinical Research 82

Pharmaceutical Technology

JUNE 15, 2023

Two of the biggest challenges facing healthcare R&D are the sheer volume of data and the unique characteristics of every person’s health. Learn more about the role of AI in drug development and how healthcare researchers are using it to shake up the field. Artificial intelligence (AI) and other technologies offer a way forward.

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Development Drugs Clinical Trials Clinical Trials 130

Cloudbyz

MARCH 22, 2023

Risk-based monitoring (RBM) is a clinical trial monitoring approach that focuses resources on areas that pose the greatest risk to data quality and patient safety. Improved data quality: By focusing on critical data points, RBM can improve the quality of data collected, ensuring that it is accurate, complete, and consistent.

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Clinical Trials Clinical Trials Trials Compliance 52

Rethinking Clinical Trials

AUGUST 28, 2023

 Speakers Prof Sir Martin Landray, FMedSci Professor of Medicine & Epidemiology University of Oxford Chief Executive, Protas Khair ElZarrad, PhD, MPH Director, Office of Medical Policy Center for Drug Evaluation and Research (CDER) U.S. The new structure aims to provide clarity and better readability.

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Clinical Trials Clinical Trials Trials Development 130

Rethinking Clinical Trials

AUGUST 28, 2023

 Speakers Prof Sir Martin Landray, FMedSci Professor of Medicine & Epidemiology University of Oxford Chief Executive, Protas Khair ElZarrad, PhD, MPH Director, Office of Medical Policy Center for Drug Evaluation and Research (CDER) U.S. The new structure aims to provide clarity and better readability.

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Clinical Trials Clinical Trials Trials Development 130

XTalks

DECEMBER 13, 2023

Related: 3 Food and Beverage Industry Trends for 2023 The Critical Role of Data In his 2024 food industry trends, Are Traasdahl , founder and CEO of Crisp , presents a forward-looking view of the food and beverage industry. Smarter utilization of data will also be key to reducing food waste and improving product availability.

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Branding Production Protein Packaging 105

Cloudbyz

OCTOBER 19, 2023

Enhanced Collaboration: A unified platform fosters better communication and collaboration among research teams, sponsors, investigators, and other stakeholders. Data Integration: It allows for seamless integration of data from various sources, including electronic health records and wearable devices, ensuring data accuracy and consistency.

Clinical Trials 83

Clinical Trials Clinical Trials Trials Compliance 83

XTalks

NOVEMBER 27, 2023

Pharmaceutical companies are navigating the challenges and opportunities presented by AI-driven analytics, wearable devices and patient-generated data, redefining how adverse events are detected, reported and managed. Huh warns that AI can make it challenging to handle sensitive data like healthcare information responsibly and securely.

Pharmacy 111

Pharmacy Compliance Drugs Life Science 111

XTalks

JULY 7, 2023

Data on commercial negotiated prices and cash prices for eight specific services were analyzed from 156 POHs and 1,116 non-POHs in 78 hospital referral regions (HRRs). Furthermore, the research indicated that POHs served fewer Medicaid patients and provided less charity care compared to non-POHs.

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Regulation Marketing Licensing Licensing 98

Drug Discovery World

DECEMBER 6, 2022

1 Vaccine development was conducted at great pace and within a year of the first infection being reported, the first Covid-19 vaccine to report phase III clinical trial data demonstrated unexpectedly high efficacy and cleared regulatory efficacy criteria with ease. Pre-specification of effect size .

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Development Drugs Vaccination Vaccine 98

Cloudbyz

MAY 24, 2023

The pursuit for the most effective and safe products requires rigorous clinical research, which involves meticulous trial design, recruitment, data collection, and subsequent analysis. Let’s delve into how these solutions can accelerate research and bring products to market faster.

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Clinical Trials Clinical Trials Production Trials 52

Drug Discovery World

MAY 8, 2024

This new era of digitalisation is exciting and promises great opportunity, but it does introduce questions as to how regulators can keep up to combat concerns around how AI should be monitored, data ethics, data privacy, and safety with appropriate supporting legislation.

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Clinical Trials Clinical Trials Trials Regulation 64

pharmaphorum

JANUARY 14, 2022

The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research.

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Clinical Trials Clinical Trials Trials Regulation 125

WCG Clinical

JULY 7, 2023

Fair market value (FMV) can impact clinical trial budgets at research sites in many ways. In short, fair market value (FMV) is the selling price agreed upon by a buyer and seller, but in the context of clinical trials, FMV is used to determine the appropriate compensation for various goods and services provided by research sites.

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Clinical Trials Clinical Trials Trials Marketing 52

Cloudbyz

FEBRUARY 21, 2023

Quality Management Systems (QMS) are an essential component of clinical operations as they manage the quality of clinical research. In clinical operations, QMS manages the quality of clinical research by defining, documenting, and implementing standard operating procedures and guidelines.

Clinical Trials 52

Clinical Trials Clinical Trials Compliance Trials 52

pharmaphorum

JUNE 8, 2021

The UK’s decision to set back the start date of a new patient data-sharing scheme by two months has been welcomed by privacy campaigners, who have claimed it was being rushed through without sufficient public scrutiny. And with any use of data, trust is crucial.”

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