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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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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Imperical Blog

APRIL 11, 2023

This final installment explores clinical trial retention and compliance. Are you waiting too long to begin planning patient retention and… The post Hidden Causes of Clinical Trial Retention and Compliance Issues appeared first on Imperial Clinical Research Services Blog.

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Imperical Blog

APRIL 11, 2023

This final installment explores clinical trial retention and compliance. Are you waiting too long to begin planning patient retention and… The post Hidden Causes of Clinical Trial Retention and Compliance Issues appeared first on Imperial Clinical Research Services Blog.

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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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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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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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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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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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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. Covid-19: adversity leading to improvements.

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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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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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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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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 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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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? Payer issues should also be addressed, Willenberg noted.

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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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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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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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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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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.

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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 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

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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Advarra

OCTOBER 17, 2023

Research sites play a pivotal role in clinical trials, responsible for participant recruitment, data collection, safety monitoring, regulatory management, overall trial conduct, and more. Oftentimes, sites hold off billing for specific visits or procedures related to a trial if they are not 100% sure the item is billable.

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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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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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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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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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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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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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WCG Clinical

SEPTEMBER 19, 2023

Mancinelli’s presentation, titled “Deploying AI Across the Clinical Trial Life Cycle to Deliver Efficient, Safe and Impactful Clinical Research,” will cover case examples that highlight the impact of machine learning and large language models while exploring an interoperable platform that drives efficiency and safety in clinical trial operations.

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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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Worldwide Clinical Trials

APRIL 25, 2024

Authors: Rolana Avrumson, MS, VP Clinical Projects, Clinical Assessment Technologies; Barry Dussault Executive Director, Project Management, Franchise Area Lead, Pain Upwards of 58% of patients experience moderate to severe post-surgical pain, while some research places that figure even higher at a staggering 80%.

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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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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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WCG Clinical

JULY 12, 2023

Princeton, NJ, July 12, 2023 – WCG, one of the world’s leading providers of solutions that measurably improve the quality and efficiency of clinical research, released its 2023 Avoca State of the Industry Report. Avoca joined the WCG family of companies in April 2021. For more information, visit www.theavocagroup.com.

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