Cloudbyz

MARCH 1, 2023

Clinical trials are a critical component of drug development in the life sciences industry. Conducting clinical trials requires significant investments of time and resources, including the management of budgets and payments. Following are the benefits of digitizing clinical trials budgets and payments.

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Clinical Trials Clinical Trials Trials Compliance 88

pharmaphorum

JANUARY 17, 2023

Late last year, pharmaphorum spoke with AstraZeneca’s Ben Challis, VP and head of translational science and experimental medicine, cardiovascular, renal, and metabolism (CVRM), together with Magnus Jörnten-Karlsson, executive director of Unify. Unify, launched in December 2020, is AstraZeneca’s patient app and clinical trial support tool.

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Clinical Trials Clinical Trials Medicine Trials 98

pharmaphorum

JULY 8, 2022

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use. Source: Izmailova et al, 2017.

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Clinical Trials Clinical Trials Trials Regulation 88

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. What Differentiates Mid-Size CROs?

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Clinical Development Clinical Trials Clinical Trials Trials 333

Cloudbyz

JUNE 11, 2023

This transformation has permeated the domain of clinical trials, which is now embracing the concept of decentralized clinical trials (DCTs). This paper delves deep into the universe of DCTs, their distinctiveness from conventional trials, their inherent benefits, existing hurdles, and measures to bolster their adoption.

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Clinical Trials Clinical Trials Trials Compliance 72

pharmaphorum

OCTOBER 1, 2020

Many companies in the life sciences industry are slow to adopt new technologies. Running clinical trials costs a lot of money! Many clinical trials fail. For example, it can be difficult to recruit patients or they may drop out during the trial. There’s a huge amount of complex data to deal with.

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Clinical Trials Clinical Trials Trials Production 109

ACRP blog

SEPTEMBER 11, 2023

Overview Decentralized clinical trials (DCTs) represent the shift towards implementing virtual research studies using digital health tools to gather data and monitor patient activity. During the COVID-19 pandemic, the clinical industry experienced significant disruption to traditional practices.

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Clinical Trials Clinical Trials Trials Drugs 69

XTalks

DECEMBER 22, 2022

Neilan has contributed to the rare disease community through his comprehensive work in the rare disease space that has included research, academia, medical practice and clinical trial design and execution. Can you tell us a bit about the work you are doing at NORD and how it impacts clinical trials for rare diseases?

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Clinical Trials Clinical Trials Trials Clinical Research 98

ACRP blog

MAY 16, 2023

Clinical trials have been the foundation of medical research for almost 250 years. James Lind, a Scottish naval surgeon and physician, is widely credited with performing the first comparative clinical trial. For that reason, every May 20 we proudly join the scientific community in celebrating Clinical Trials Day.

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Clinical Trials Clinical Trials Trials Clinical Research 98

pharmaphorum

FEBRUARY 1, 2022

Across the industry, pharma companies are turning to AI and real-world data to address many of the challenges of running clinical trials. Can the combined potential of new AI technologies and real-world patient data hold the key to overcoming the challenges in clinical trial design that have historically led to trial failure?

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Clinical Trials Clinical Trials Trials Engineer 100

Cloudbyz

MARCH 17, 2023

Good Clinical Practice (GCP) is an international standard that outlines ethical and scientific quality requirements for designing, conducting, recording, and reporting clinical trials involving human subjects. Deviations from the protocol can impact the study’s integrity and raise ethical concerns.

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Clinical Trials Clinical Trials Trials Life Science 52

pharmaphorum

JULY 21, 2021

Think of the R&D dollars that could be saved if artificial intelligence (AI) modelling could tell you at an early stage whether a drug was likely to succeed in clinical trials, and ultimately reach the market. The results were interesting, but the team wanted to do better.

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Clinical Trials Clinical Trials Trials Development 104

pharmaphorum

MAY 27, 2022

This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. The same principles are increasingly being applied to clinical trials to improve diversity, mitigate bias, and reinforce inclusion in clinical trials.

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Clinical Trials Clinical Trials Trials Packaging 78

Cloudbyz

JUNE 10, 2023

21 CFR Part 11 is a crucial component of regulatory compliance in clinical trials and, more broadly, any industry subject to the regulations of the U.S. This blog post will serve as a comprehensive guide to understanding and implementing 21 CFR Part 11 compliance in your clinical trials. Let’s explore.

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Compliance Clinical Trials Clinical Trials Trials 89

XTalks

MAY 6, 2022

In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinical trials. Listen below to hear the interview.

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Clinical Trials Clinical Trials Trials Life Science 98

Cloudbyz

APRIL 17, 2023

Clinical trials are an important part of the healthcare system, as they provide patients with access to innovative treatments that may not be available through traditional treatment options. Large healthcare systems are uniquely positioned to play a critical role in the development and implementation of clinical trials.

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Clinical Trials Clinical Trials Trials Development 52

Rethinking Clinical Trials

MARCH 28, 2023

It is an independent, nonprofit, research institute and leading funder of patient-centered comparative clinical effectiveness research (CER). It is an independent, nonprofit, research institute and leading funder of patient-centered comparative clinical effectiveness research (CER). has 8 clinical research networks across the country.

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Clinical Trials Clinical Trials Trials Research 130

Drug Discovery World

OCTOBER 2, 2023

Sophie Winandy , Executive Director of Medical Imaging at ICON explores the benefits of AI and how it can be integrated throughout medical imaging within clinical trials. However, integrating AI can streamline workflows to save time and mitigate the potential for human error.

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Clinical Trials Clinical Trials Trials Radiology 59

XTalks

JANUARY 17, 2024

Understanding this condition and its various manifestations, as well as developing effective treatments, has been the focus of ongoing investigation in lupus clinical research for many years. In this pursuit, the importance of real-world data (RWD) in advancing lupus solutions cannot be overstated.

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Clinical Trials Clinical Trials Trials Life Science 52

Rethinking Clinical Trials

JULY 12, 2023

Stephanie Morain discussed the results of a recent bioethics initiative to explore ethical considerations for data sharing in the context of pragmatic clinical trials. Morain said that 2main reasons contributed to why data sharing may be different in the context of pragmatic clinical trials.

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Trials Clinical Trials Clinical Trials Research 130

XTalks

JULY 7, 2022

The Ireland-based company Neuromod Devices Limited has announced positive results from a second large-scale clinical trial of their bimodal neuromodulation device Lenire® for the treatment of tinnitus. XTALKS WEBINAR: Why Medical Device QMS and UDI Data Quality Matters. Lenire’s Second Large-Scale Clinical Trial.

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Clinical Trials Clinical Trials Trials Development 105

Drug Discovery World

JULY 24, 2023

Paul O’Donohoe , Senior Director, eCOA Product and Science at Medidata, looks at the potential of decentralised clinical trials following the Covid-19 pandemic and how the industry will be affected going forward. The role that Covid-19 played in advancing decentralised clinical trials (DCTs) cannot be underestimated.

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Clinical Trials Clinical Trials Trials Contamination 52

Drug Discovery World

FEBRUARY 9, 2023

Stitch Health is a London-based start-up, on a mission to improve clinical trials by measuring and surfacing each patient’s experience. million seed funding to create the definitive patient retention platform for clinical trials. MT: What other aspects of clinical trials do you feel could be improved upon?

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Clinical Trials Clinical Trials Trials Research 52

WCG Clinical

SEPTEMBER 11, 2023

To ensure the survival of the clinical trial industry, the voice of the patient must be listened to. It calls for a comprehensive, stakeholder-inclusive approach to clinical trial design, placing particular emphasis on patient-centricity. Patient centricity is a necessity and a regulatory expectation.

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Clinical Trials Clinical Trials Trials Doctors 52

pharmaphorum

JUNE 11, 2021

Abel Archundia discusses how COVID-19 has highlighted the importance of securing clinical trials against cyber threats. They highlight the importance of mastering two positive and related trends in healthcare right now: close collaboration across increasingly complex supply chains and sophisticated use of data.

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Clinical Trials Clinical Trials Trials Compliance 109

ACRP blog

JUNE 14, 2022

Looking for ways to increase participation in your clinical trials? First, stop calling participants “subjects,” says Scott Gray, CEO of Clincierge, whose organization just released a research report, “Voice of the Patient,” examining the patient experience in clinical trials of rare diseases. Author: Michael Causey.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Pfizer

FEBRUARY 16, 2023

who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) Phase 3 clinical study. GCP is the international ethical and scientific quality standard for clinical trials that all clinical researchers need to follow.

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Clinical Trials Clinical Trials Vaccination Vaccine 76

ACRP blog

JUNE 15, 2023

Results of clinical trials are only as good as the data upon which they rest. This is especially true in terms of diversity—if most people in a trial are from a certain race or socioeconomic group, then the results may not be broadly applicable.

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Clinical Trials Clinical Trials Trials Nurses 59

Crucial Data Soutions

APRIL 27, 2020

The COVID-19 pandemic that struck the globe this year has drastically disrupted the state of affairs in the life sciences industry. Traditional methods of clinical data collection and trial management encountered change in mid-March as the FDA released guidance on conducting trials during the pandemic.

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Clinical Trials Clinical Trials Trials Life Science 85

XTalks

MAY 20, 2021

Today is Clinical Trials Day 2021 — a day for recognizing the importance of clinical research in protecting and improving global health. Amid the alarmist headlines posted by other media outlets, Xtalks has remained balanced in its reporting of COVID-19 clinical trial results and safety data.

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Clinical Trials Clinical Trials Trials Vaccination 105

ACRP blog

JUNE 15, 2023

Results of clinical trials are only as good as the data upon which they rest. This is especially true in terms of diversity—if most people in a trial are from a certain race or socioeconomic group, then the results may not be broadly applicable.

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Clinical Trials Clinical Trials Trials Nurses 52

Cloudbyz

MAY 13, 2023

Overview: Clinical site monitoring metrics and Key Performance Indicators (KPIs) are fundamental tools in the realm of clinical trial management. They provide a way to quantify and evaluate critical aspects of a clinical trial’s performance at individual investigative sites.

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Clinical Trials Clinical Trials Trials Compliance 52

XTalks

APRIL 29, 2021

Multiple studies have confirmed that conducting clinical trials with a diverse range of ethnicities, genders, ages, and lifestyles is essential, since these factors can impact a treatment’s effectiveness among different groups. Despite this, ethnic minorities are underrepresented in clinical trials.

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Clinical Trials Clinical Trials Trials Drugs 95

Cloudbyz

JANUARY 27, 2021

Clinical Trial Management (CTMS). Clinical Trial Budget Management. Electronic Trial Master File (eTMF). ☰ Setting up a virtual clinical trial: Things to consider. The pharmaceutical industry has been forced to find new and innovative approaches to try clinical trials. eCOA / ePRO.

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Clinical Trials Clinical Trials Trials Packaging 98

Rethinking Clinical Trials

NOVEMBER 22, 2022

A concordance analysis from ADAPTABLE, a large pragmatic, comparative effectiveness trial, found low to moderate agreement between patient-reported health data and data derived from the electronic health record (EHR). Results of the study were published in JAMA Cardiology.

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XTalks

NOVEMBER 7, 2022

These tumor-derived entities are used to derive genomic and proteomic data. Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials.

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Clinical Trials Clinical Trials Trials FDA Approval 98

Cloudbyz

MAY 24, 2023

Clinical trials play a crucial role in advancing medical research and developing new treatments and therapies. In order to ensure the reliability and validity of the data collected during these trials, rigorous data management practices and audits are necessary. Here are some crucial elements to include: a.

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Compliance Clinical Trials Clinical Trials Trials 52