Cloudbyz

JUNE 5, 2023

In the fast-paced world of clinical research, managing essential Trial Master Files (TMFs) efficiently, while ensuring quality and compliance, is paramount. This automation also minimizes human errors and ensures consistent document organization across trials.

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Compliance Clinical Trials Clinical Trials Trials 73

Cloudbyz

AUGUST 9, 2023

The clinical research landscape is rapidly evolving. As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. This is where the platform approach comes into play.

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Clinical Research Research Clinical Trials Clinical Trials 52

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. ICH-GCP) Adherence to reporting requirements (e.g.,

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Compliance Clinical Trials Clinical Trials Trials 52

XTalks

MAY 9, 2023

Clinical trial manager jobs are vital for the development and execution of clinical trials, which are essential for developing new treatments for diseases. In this article, we discuss the job duties, education and experience requirements, outlook and salary expectations for clinical trial managers.

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Clinical Trials Clinical Trials Trials Clinical Research 98

Clinical Trial Podcast

FEBRUARY 23, 2021

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”.

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Clinical Research Research Clinical Trials Clinical Trials 105

VirTrial

AUGUST 21, 2021

In clinical trials, the application of telemedicine technology is still evolving. Clinical trials have far more considerations and challenges beyond the basic patient-clinician interaction. Training and support by clinical science and medicine experts familiar with clinical trial operations.

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Clinical Research Research Clinical Trials Clinical Trials 97

Cloudbyz

MAY 17, 2022

Until recently, clinical trials have been performed in a mostly paper-based processes. Advancements in technology, surge in remote work and digitization of the processes is driving the clinical research industry and consequently, there is increased use of electronic records and electronic signatures to support these processes.

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Compliance Regulation Clinical Research Clinical Trials 52

Cloudbyz

MAY 17, 2022

Until recently, clinical trials have been performed in a mostly paper-based processes. Advancements in technology, surge in remote work and digitization of the processes is driving the clinical research industry and consequently, there is increased use of electronic records and electronic signatures to support these processes.

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Compliance Clinical Research Regulation Clinical Trials 52

pharmaphorum

NOVEMBER 15, 2022

A renaissance in vaccines research is just one example of something good to come out of the pandemic. For the clinical trials industry, the pandemic forced new ways of working and fresh ways of thinking about clinical research and how to conduct it remotely.

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Clinical Research Research Clinical Trials Clinical Trials 103

WCG Clinical

AUGUST 22, 2023

PRINCETON, NJ, August 22, 2023: WCG, the global leader in providing solutions that measurably improve the quality, efficiency, and safety of clinical research, today announces the WCG MAGI Clinical Research Conference, an educational mainstay for clinical trial professionals for more than 15 years, is going virtual for its fall 2023 event.

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Clinical Research Research Compliance Clinical Trials 52

Cloudbyz

MAY 17, 2022

Until recently, clinical trials have been performed in a mostly paper-based processes. Advancements in technology, surge in remote work and digitization of the processes is driving the clinical research industry and consequently, there is increased use of electronic records and electronic signatures to support these processes.

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Compliance Regulation Clinical Research Clinical Trials 52

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.

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Trials Clinical Trials Clinical Trials Clinical Research 59

ACRP blog

OCTOBER 19, 2022

In the turbulent waters of the clinical research workforce, with high turnover and burnout circling like relentless sharks, several leading organizations have found ways to navigate their way through and around the worst of the storm. It required us to look at student frustrations in finding jobs in clinical research,” Traynor says. “We

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Clinical Research Research Clinical Trials Clinical Trials 98

Cloudbyz

MAY 15, 2024

Selecting the right eSource system for clinical trials is a critical decision that can significantly impact the efficiency and success of your research projects. Data Integrity and Compliance ERES Compliance: Confirm the system complies with Electronic Records/Electronic Signatures (ERES) regulations such as FDA 21 CFR Part 11.

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Clinical Trials Clinical Trials Compliance Regulation 52

Cloudbyz

MARCH 15, 2023

March 15, 2023 /PRNewswire/ — Cloudbyz, a leading provider of unified clinical trial management solutions, today announced the launch of its innovative Electronic Data Capture (EDC) product, Cloudbyz EDC 2.0. Designed to revolutionize the clinical research landscape, Cloudbyz EDC 2.0 NAPERVILLE, Ill.

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Clinical Research Research Clinical Trials Clinical Trials 52

Pharmaceutical Technology

APRIL 20, 2023

The face of clinical research is evolving. Rather than bringing patients to sites, study teams are now exploring ways they can bring the trial to patients using a varying combination of direct-to-patient drug shipments, home nursing, video conferencing, and electronic data collection. Everybody got used to doing things remotely.

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Clinical Trials Clinical Trials Trials Nurses 130

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 70

Drug Discovery World

DECEMBER 18, 2023

Digital biomarkers promise to transform preventive medicine and clinical trials, but also raise issues of security, regulation and potential disparities in access. Deepika Khedekar, Clinical Trial Lead at IQVIA, provides an overview of the pros and cons, and suggests a possible solution.

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Clinical Research Research Clinical Trials Clinical Trials 59

Cloudbyz

MARCH 13, 2023

Clinical trial data management involves collecting, processing, analyzing, and reporting data from clinical trials in a systematic and efficient manner. Effective data management is critical for ensuring the safety and efficacy of the tested intervention and maintaining the integrity of the trial results.

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Clinical Trials Clinical Trials Trials Compliance 52

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. A delay in trials or approval can significantly impact the product’s success and the company’s bottom line.

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Clinical Trials Clinical Trials Production Trials 52

Drug Discovery World

MAY 17, 2024

Deepika Khedekar , Associate Centralized Clinical Trial Lead at IQVIA Inc, looks at the challenges of utilising artificial intelligence (AI) in oncology clinical research. MIT research 4 tells us a hard truth: about 95% of these trials fall short, leaving behind a trail of broken hopes for cancer patients each year.

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Trials Clinical Trials Clinical Trials Protein 52

VirTrial

FEBRUARY 12, 2024

Clinical trials continue to become more complex and whilst there is extensive evidence demonstrating the improvement of data quality through electronic collection of Clinical Outcomes Assessment (eCOA) data, trial complexity can place additional burden on clinical research sites.

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Trials Clinical Trials Clinical Trials Clinical Research 52

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 80

pharmaphorum

SEPTEMBER 9, 2022

The pandemic forced clinical trial sponsors to change their processes, with a more technology-driven approach and, according to a new study by Medidata, the sector is now “stronger than ever” as a result. ” The post COVID-19 has changed clinical trials for the better, says Medidata appeared first on.

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Clinical Trials Clinical Trials Trials Compliance 96

Cloudbyz

MAY 15, 2023

Clinical trials play a critical role in medicine and healthcare, offering valuable insights that inform treatment options, drug development, and patient care. 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.

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Clinical Trials Clinical Trials Trials Compliance 69

Clinical Trial Podcast

JUNE 6, 2021

Clinical trials are conducted in compliance with regulations. Simply stated, you need a clinical and regulatory strategy when it comes to conduct of clinical trials for medical devices. She does a great job of tailoring our conversation to make it applicable for clinical trial professionals.

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Clinical Trials Clinical Trials Trials Regulation 59

pharmaphorum

DECEMBER 2, 2022

Enrolling for clinical trials has become more challenging in recent years, with trial competition, increasingly complex protocols, and precision medicine targeting more niche patient populations. These potential study risks can lead to costly deviations and amendments, enrolment difficulties, and reduced patient compliance.

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Trials Clinical Trials Clinical Trials Clinical Research 98

Imperical Blog

SEPTEMBER 7, 2023

Avoiding “Customs Chaos” in Clinical Trials Means Working Closely with Your Importer of Record Many global clinical trial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Imperical Blog

SEPTEMBER 7, 2023

Avoiding “Customs Chaos” in Clinical Trials Means Working Closely with Your Importer of Record Many global clinical trial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

JANUARY 4, 2024

The development of medical devices is a meticulous process, spanning from initial pilot trials to post-market surveillance. In this blog post, we will delve into the nuances of adverse event reporting across the various phases of medical device trials and highlight essential considerations for stakeholders involved in this intricate process.

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Trials Marketing Compliance Regulation 59

Cloudbyz

FEBRUARY 20, 2024

The healthcare and pharmaceutical industries are increasingly adopting advanced technologies to streamline clinical trial management processes. Lack of flexibility: Rigid systems struggle to adapt to changing regulations, trial protocols, and industry best practices.

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Clinical Trials Clinical Trials Compliance Trials 52

ACRP blog

FEBRUARY 26, 2024

My office manages all of the cancer clinical trials for all types of cancer. We owe all of it to clinical trials—to the people who volunteer to use their own bodies to further the science, and to the researchers who tirelessly work to find new ways to stop what once seemed unstoppable. They’re saving my life.

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Clinical Trials Clinical Trials Trials Nurses 59

XTalks

JANUARY 19, 2022

The way in which clinical trials are conducted is entering a new dimension as clinical trial operations are becoming more adaptable. In DCTs/HCTs, one or more components of the trial can be managed remotely from the patient’s home using wearable and remote monitoring technology. MRI scan, endoscopy, etc.)

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Clinical Trials Clinical Trials Trials Clinical Research 98

Worldwide Clinical Trials

NOVEMBER 10, 2023

At this year’s annual Pain Therapeutics Summit , which took place in San Diego, CA, October 19 to 20th, I heard brilliant presentations on novel pain medication development, targeted discoveries, pain classifications, the NIH HEAL Initiative , trial designs, biomarkers, and others. As mentioned, these are but a few topics for contemplation.

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Clinical Trials Clinical Trials Trials Compliance 184

Cloudbyz

SEPTEMBER 19, 2023

Introduction Clinical research is a complex and highly regulated field where meticulous attention to detail is paramount. It can read and comprehend complex documents, such as clinical trial protocols, and extract pertinent information intelligently. This is crucial for regulatory compliance and audit purposes.

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Compliance Clinical Trials Clinical Trials Clinical Research 84

Clinical Trial Podcast

JULY 18, 2020

Have you been tasked to develop a clinical trial budget? Well, you’re in luck because I’m going to share everything you need to know about clinical trial costs. Clinical trial budgets are often put together in haste. Developing a clinical trial budget can be a confusing exercise for sponsors and CROs.

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Clinical Trials Clinical Trials Trials Clinical Research 98

VirTrial

OCTOBER 14, 2020

The training and certification initiative aims to provide sustainable study and patient opportunities for investigator sites, while demonstrating telemedicine technology competencies in the eyes of international regulators. That’s why we provide our Virtual Trial Capable training for sites.” ” About BlueCloud®.

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Compliance Clinical Research Clinical Trials Clinical Trials 98