AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 15, 2023

The National Accreditation Board for Testing and Calibration Laboratories (NABL) has issued clarification on NABL accredited Conformity Assessment Body (CAB) combined International Laboratory Accreditation Co-operation (ILAC) Mutual Recognition Arrangement (MRA) mark for effective compliance.

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ProRelix Research

DECEMBER 28, 2023

Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […] The post Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management appeared first on ProRelix Research.

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FDA Compliance Compliance Clinical Trials Clinical Trials 52

Worldwide Clinical Trials

APRIL 3, 2024

Are you aware of the challenges you must address for a successful radiopharmaceutical trial? Enhancing Patient Participation in Radiopharmaceutical Trials Patient recruitment is a critical yet challenging part of radiopharmaceutical trials.

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Trials Clinical Trials Clinical Trials Compliance 204

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 97

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 87

Cloudbyz

APRIL 17, 2024

Decentralized clinical trial (DCT) platforms represent a paradigm shift in the way clinical research is conducted. By leveraging technology, DCTs aim to make clinical trials more accessible and convenient for patients, reduce costs and increase efficiency.

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Clinical Trials Clinical Trials Trials Compliance 102

ACRP blog

JUNE 30, 2023

Clinical trial billing compliance—ensuring that charges for therapies and other study-related elements are sent to the appropriate party—is a key concern for academic medical centers and other research organizations. Do you lose revenue in research? Are you calculating fair market value correctly?

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Compliance Clinical Trials Clinical Trials Trials 52

Cloudbyz

MAY 17, 2024

This Act is poised to significantly change the clinical trials landscape within the life sciences sector. As AI increasingly becomes a cornerstone in clinical research and drug development, it is crucial for industry stakeholders to grasp the extensive implications of this regulation.

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Life Science Clinical Trials Clinical Trials Trials 91

ACRP blog

FEBRUARY 28, 2024

Department of Justice (DOJ) officials have made it clear in the last few years that investigation and enforcement of clinical research misconduct is an increasing priority. Mingqing Xiao ) Clearly, there are a multitude of regulations that impact clinical research, and it’s vital to stay up to date on the latest industry developments.

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Compliance Research Clinical Research Clinical Trials 59

Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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Clinical Research Compliance Research Regulation 52

Worldwide Clinical Trials

MARCH 20, 2024

One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinical trials.

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Clinical Trials Clinical Trials Trials Genetics 130

Roots Analysis

OCTOBER 29, 2023

One particular area that has seen significant innovation is the realm of clinical trials. Traditionally conducted at centralized sites like hospitals or clinics, the latest trend is moving towards decentralized clinical trials (DCTs). What are Decentralized Clinical Trials (DCTs)?

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Clinical Trials Clinical Trials Clinical Research Trials 40

ACRP blog

OCTOBER 19, 2023

Research sites play a pivotal role in clinical trials in that they are responsible for participant recruitment, data collection, safety monitoring, regulatory management, overall trial conduct, and more. This fear of non-compliance can significantly affect a site’s bottom line. This is a sponsored message.

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Clinical Research Research Compliance Clinical Trials 106

Cloudbyz

MARCH 22, 2024

In the realm of clinical research, the efficient management of data is paramount. However, traditional methods of data entry, particularly from diverse and unstructured documents, have long posed challenges for researchers, leading to inefficiencies, errors, and compliance risks. Scalability: Cloudbyz’s ClinExtract.AI

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Clinical Trials Clinical Trials Trials Compliance 79

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

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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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

JUNE 9, 2024

In the realm of clinical trials, particularly in oncology and rare disease research, SDOH play a pivotal role in shaping patient participation, adherence, and overall outcomes. Integrating eClinical systems can help mitigate these disparities, enhancing the inclusivity and efficacy of clinical research.

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Clinical Trials Clinical Trials Trials Clinical Research 102

Worldwide Clinical Trials

APRIL 8, 2024

By Rolana Avrumson, MS, Vice President of Clinical Projects, Clinical Assessment Technologies In the intricate world of clinical trials, the precision and reliability of clinical assessments stand as pivotal factors in determining a trial’s success.

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Clinical Trial Podcast

JULY 31, 2022

Who owns the clinical trial data generated in industry sponsored or investigator initiated clinical trials? What responsibilities do Sponsors, CROs, or Sites have when it comes to sharing clinical trial results with patients? To answer these questions and more, I invited Darshan Kulkarni to the show.

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ACRP blog

FEBRUARY 2, 2023

Many clinical research professionals “fell into” this career pathway rather than choosing it deliberately from the outset. Multiple career trajectories can bring individuals into clinical research,” said Kristen Gurnea, MPH, CCRC, ACRP-PM, Manager of Clinical Research at Renown Health.

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Clinical Research Research Clinical Research Coordinator Compliance 106

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

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

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 97

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.

Clinical Trials 101

Clinical Trials Clinical Trials Trials Compliance 101

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

FDA Law Blog

MARCH 29, 2024

According to GAO, FDA is facing challenges with clinical research inspections to ensure that the sites that oversee the research that lead to drug approvals meet the necessary standards. In other words, the inspectional output was inversely proportional to the importance of clinical research.

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Clinical Research Research Clinical Trials Clinical Trials 59

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

Worldwide Clinical Trials

APRIL 25, 2024

Understanding and managing post-surgical pain is pivotal in clinical research for improving patient outcomes and care strategies. Here, we delve into how these challenges can be navigated with the aid of clinical assessment services, leveraging the expertise of Worldwide Clinical Trials’ Clinical Assessments Technologies (CAT) team.

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Clinical Trials Clinical Trials Compliance Trials 130

Clinical Trial Podcast

AUGUST 24, 2023

Unlike an electrical engineer or a plumber, clinical research roles are not explicitly defined or categorized as such, in government employment databases. There are no certification or degree requirements to work as a clinical research professional either. Erika holds her B.A. from the University of Vermont, her M.A.

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Cloudbyz

FEBRUARY 29, 2024

AI-enabled data extraction holds immense promise in expediting case processing within clinical trials, offering a transformative approach to streamline workflows and enhance efficiency. In this blog, we delve into the potential of AI in pharmacovigilance and its implications for clinical trial safety monitoring.

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Clinical Trials Clinical Trials Trials Compliance 59

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

Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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Clinical Trials Clinical Trials Trials Compliance 40

Advarra

JUNE 27, 2023

Clinical trials are studies involving human volunteers to research ways to prevent, detect, and treat various medical conditions. A clinical trial investigating a drug or therapy is typically divided into four phases: Phase I, Phase II, Phase III, and Phase IV.

Clinical Research 52

Clinical Research Research Clinical Trials 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.

Compliance 52

Compliance Regulation Clinical Research Clinical Trials 52

Cloudbyz

FEBRUARY 29, 2024

AI-enabled data extraction holds immense promise in expediting case processing within clinical trials, offering a transformative approach to streamline workflows and enhance efficiency. In this blog, we delve into the potential of AI in pharmacovigilance and its implications for clinical trial safety monitoring.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52