Cloudbyz

AUGUST 30, 2024

In the rapidly evolving landscape of clinical research, data has become one of the most valuable assets. Clinical Trial Management Systems (CTMS) play a pivotal role in managing this data, encompassing everything from patient information and trial protocols to sensitive medical records and regulatory documents.

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Compliance Clinical Trials Clinical Trials Trials 97

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 111

Advarra

AUGUST 8, 2024

This landmark legislation aims to create a comprehensive framework for AI development and deployment, ensuring ethical use, safety, and transparency for European Union (EU) residents. This article explores the likely impact of the AI Act on software and systems used in clinical research and how it affects entities outside the EU.

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Clinical Research Research Compliance Clinical Trials 98

ACRP blog

MAY 6, 2024

Also sharing advice on breaking free of unproductive habits on Saturday was Suzanne Kincaid, CCRA, ACRP-PM, FACRP, Consultant and Owner of Responsibility Research, in her session on “The Intersection of Technology and People: Harnessing Technology to Increase Efficiency and Build Relationships.” On Day Two of ACRP 2024 in Anaheim, Calif.,

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Clinical Research Research Clinical Trials Clinical Trials 105

ACRP blog

SEPTEMBER 12, 2024

ACRP reached out to experts from graduate programs in clinical research for a snapshot of how education in this field, especially at the master’s degree level, is holding up amidst rapidly evolving changes in the research enterprise itself. This diversity suggests varying levels of prior research experience and knowledge.

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Clinical Research Research Clinical Trials Clinical Trials 110

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 105

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

Drug Patent Watch

DECEMBER 11, 2024

The biopharmaceutical industry has witnessed a significant surge in the number of therapeutic molecules in development, leading to a corresponding increase in the number of contract development and manufacturing organizations (CDMOs).

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Compliance Development Manufacturing Production 98

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 We want to show them the options” that exist in the clinical trial industry, he adds.

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Clinical Research Research Clinical Trials Clinical Trials 98

XTalks

DECEMBER 9, 2024

Notably, the FDA can now mandate that confirmatory trials begin before approval, ensuring proactive validation of clinical benefits. The draft also formalizes withdrawal procedures for non-compliance, including delayed studies or failure to confirm benefits.

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Clinical Trials Clinical Trials Compliance Trials 105

Advarra

NOVEMBER 14, 2024

Strengthened regulatory compliance: Different countries have varying regulatory requirements and expectations. This compliance is crucial for the successful regulatory approval and dissemination of trial results. A globally diverse DMC ensures the trial adheres to local regulations while maintaining high ethical standards.

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Clinical Trials Clinical Trials Trials Clinical Research 97

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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Clinical Trials Clinical Trials Compliance Trials 98

Clinical Trial Podcast

JULY 31, 2022

He is currently the Principal Attorney of Kulkarni Law Firm where he focuses his practice on providing healthcare companies with legal, compliance, and regulatory advice. He has led rare disease pharmaceutical companies in developing global programs to foster clinical trial transparency and enhance public health.

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Clinical Research Clinical Trials Clinical Trials Research 80

ACRP blog

OCTOBER 22, 2024

The clinical research industry plays a vital role in advancing medical knowledge and improving healthcare; however, the increasing complexity of clinical trials has created a perfect storm of challenges for clinical research sites, posing significant risks to the efficiency, effectiveness, and sustainability of clinical trials at large.

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Trials Clinical Research Clinical Trials Clinical Trials 59

ACRP blog

AUGUST 7, 2024

Within the clinical research enterprise, as can be seen elsewhere in business and regulatory landscapes, the terms “quality” and “compliance” often intersect, creating what some feel is a symbiotic relationship crucial for organizational success.

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Compliance Clinical Research Production Regulation 59

XTalks

APRIL 8, 2025

Sponsors must navigate varying approval processes, compliance standards and reporting requirements to ensure that trials meet both local and international guidelines. As Thomas says, The accessibility of clinical trials and clinical research is what drives a significant amount of that cross-country movement.

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Clinical Trials Clinical Trials Trials Gene Therapy 88

XTalks

DECEMBER 4, 2023

But today, with a rise in molecularly targeted therapies, oncology development has shifted to identifying an optimal biologic dose that balances toxicity with efficacy. Project Optimus is intended to reform the dose optimization and dose selection paradigm in oncology drug development,” says Dr. Confeld.

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Development Drugs Clinical Trials Clinical Trials 111

XTalks

NOVEMBER 15, 2024

MDS are a group of blood disorders caused by abnormal development of blood cells in the bone marrow. This progression occurs when the abnormal cells in the bone marrow increase uncontrollably, leading to the development of a more aggressive form of blood cancer. “We

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Trials HR Immune Response FDA Approval 105

XTalks

JULY 9, 2024

In the dynamic landscape of clinical trials, ensuring compliance and maintaining high-quality standards are paramount. The field of quality and compliance in clinical trials is undergoing significant transformations driven by technological advancements, regulatory changes and evolving industry practices.

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Compliance Clinical Trials Clinical Trials Trials 59

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 Research Compliance Clinical Trials 52

Worldwide Clinical Trials

APRIL 3, 2024

As with other targeted therapies, radiopharmaceutical development requires unique and specialized strategies to ensure successful execution. Targeted Outreac h: Developing relationships with KOLs specializing in your indication can create a referral pipeline for suitable trial participants.

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Trials Clinical Trials Clinical Trials Compliance 204

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 102

Cloudbyz

DECEMBER 22, 2024

This achievement solidifies Cloudbyzs position as a trusted partner in advancing clinical research through cutting-edge, cloud-based technologies. Cloudbyzs dual recognition underscores its commitment to innovation , regulatory compliance, and enhanced trial efficiency.

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Compliance Clinical Trials Clinical Trials Life Science 52

Cloudbyz

NOVEMBER 22, 2024

This prestigious acknowledgment places Cloudbyz among the top-performing companies globally, known for delivering scalable and intuitive CTMS solutions that empower clinical research teams. Global Regulatory Compliance: Ensures compliance with 21 CFR Part 11 and other global regulations, reducing compliance risks.

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Life Science Clinical Trials Clinical Trials Compliance 52

Cloudbyz

AUGUST 13, 2024

In the realm of clinical trials, regulatory compliance is a cornerstone that ensures the integrity, reliability, and safety of collected data. Electronic Data Capture (EDC) systems have become integral to modern clinical research, offering streamlined data management and enhanced accuracy.

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Compliance Clinical Trials Clinical Trials Regulation 52

VirTrial

OCTOBER 14, 2020

VirTrial developed the program, using BlueCloud standards, while BlueCloud will provide its global networking infrastructure to Deliver, Distribute, Implement and Track (DDIT ) training competencies and certifications for business and compliance purposes. About VirTrial.

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Compliance Clinical Research Clinical Trials Clinical Trials 98

Worldwide Clinical Trials

APRIL 25, 2024

Understanding and managing post-surgical pain is pivotal in clinical research for improving patient outcomes and care strategies. Compliance Issues: Ensuring consistent patient participation in reporting pain levels post-surgery can be challenging.

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Clinical Trials Clinical Trials Compliance Trials 130

pharmaphorum

NOVEMBER 17, 2020

The regulatory issues of how to engage with patient organisations and involve patients in clinical trial design are covered by publications such as the ABPI’s Code of Practice. Improving the design of commercial research by listening to the patient voice. Improving the design of commercial research by listening to the patient voice.

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Clinical Trials Clinical Trials Trials Life Science 116

XTalks

JULY 25, 2024

As clinical trials become more complex, the need for user-centric design has never been more critical. His commitment to enhancing user experience is transforming how clinical trials are conducted, ensuring that both patients and site staff are supported throughout the process.

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Clinical Research Clinical Trials Clinical Trials Research 65

ACRP blog

SEPTEMBER 26, 2024

The clinical research industry is increasingly recognizing the need for diversity, especially as it relates to the Latino population and other minorities. One major development is the expansion of clinical trials into Latin America. The latest U.S. This rapid expansion is vital when considering healthcare equity.

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Clinical Research Research Clinical Trials Clinical Trials 59

XTalks

DECEMBER 19, 2024

Especially as we exited the blockbuster drug period of psychiatric development and trials were failing with huge placebo effects, I think we started realizing that the patients going into trials were not the real-world patients that were getting treated with drugs in the clinic.

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Clinical Trials Clinical Trials Trials Research 97

Cloudbyz

MARCH 5, 2024

In the intricate dance of drug discovery and development, two protagonists emerge as the cornerstones of modern medicine: biologics and small molecules. Development and Approval : Small Molecules: The pathway for development and regulatory approval is well-established, with clear guidelines for demonstrating safety and efficacy.

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Development Drugs Immune Response Manufacturing 97

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

XTalks

DECEMBER 16, 2024

Maria Hopfgarten Head of Global Medical Writing PPD Clinical Research Business of Thermo Fisher Scientific Artificial intelligence (AI) is revolutionizing industries worldwide, and medical writing is no exception. Writers act as the ultimate quality controllers to verify the clinical relevance and regulatory compliance of AI outputs.

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Compliance Clinical Research Clinical Trials Clinical Trials 52

Advarra

SEPTEMBER 19, 2024

Achieving diversity, equity, and inclusion (DEI) in clinical trials is crucial for producing comprehensive and effective medical research benefitting all communities. DEI ensures clinical research encompasses diverse populations, considering variations in gender, race, ethnicity, socioeconomic status, and more.

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Clinical Research Research Clinical Trials Clinical Trials 52

Cloudbyz

AUGUST 2, 2024

The field of oncology has seen significant progress in recent years, with the development of novel therapies and advancements in clinical research. Targeted Therapies and Immunotherapies One of the most notable trends in cancer drug research is the development of targeted therapies and immunotherapies.

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Clinical Research Research Clinical Trials Clinical Trials 52