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

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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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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ACRP blog

JANUARY 8, 2024

Few industries have a need to understand the complexities of compliance more than clinical research. The importance of compliance in clinical research cannot be stressed enough. This year’s Compliance Institute features more than 100 educational sessions across 14 unique learning tracks.

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Compliance Clinical Research Research Licensing 59

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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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

VirTrial

AUGUST 21, 2021

A telemedicine platform intended for clinical trials must provide broader functionalities to accommodate the various needs of sponsors, CROs, patients, clinicians, investigators, research site staff, and regulators, as well as meet international regulatory requirements. Multi-party encrypted calendaring.

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Clinical Research Research Clinical Trials Clinical Trials 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

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

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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Clinical Research Research Clinical Trials Clinical Trials 97

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

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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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

APRIL 3, 2023

AI/ML-based PHI and PII redaction solutions can help in clinical research by automating the process of identifying and redacting sensitive information from documents, images, and other digital content. This can help protect patient privacy, ensure compliance with data protection regulations, and reduce the risk of data breaches.

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Clinical Research Research Compliance Regulation 52

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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Clinical Research Research Gerontology Clinical Trials 40

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. By analyzing document content and metadata, generative AI can accurately determine the appropriate classification, saving significant time and effort for research teams.

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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. the effect on illnesses and side effects each dose may produce).

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Clinical Research Research Clinical Trials Clinical Trials 52

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. Visibility into and control of the financial aspects of a site’s research portfolio are key to building a successful financial site workflow.

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Clinical Research Research Compliance Clinical Trials 52

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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Compliance Clinical Trials Clinical Trials Trials 52

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 52

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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Roots Analysis

OCTOBER 29, 2023

Clinical trials are prospective biomedical research studies designed to evaluate medical, surgical or behavioral interventions in people and investigate novel approaches for the diagnosis and prevention / treatment of diseases. The following figure presents the challenges associated with decentralized clinical trials.

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WCG Clinical

SEPTEMBER 19, 2023

He will educate on the use of machine learning to mitigate trial risks, reduce costs, and detect anomalies systematically, and how AI tools may be able to assist with legal and regulatory compliance. Our mission of accelerating clinical research, together, transcends our WCG clients,” added Chief Executive Officer Sam Srivastava.

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Drug Discovery World

DECEMBER 18, 2023

With a staggering 450,000 clinical trials 3 registered globally to address these pressing health issues, and an average failure rate of 90% 4 , the call to accelerate and revolutionise clinical research is paramount. They mark a significant shift in clinical research, utilising technology to capture real-time patient data.

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Clinical Research Research Clinical Trials Clinical Trials 59

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

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

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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Clinical Research Research Clinical Trials Clinical Trials 52

Advarra

MARCH 31, 2023

Among the various regulatory bodies providing oversight on clinical research, only the institutional biosafety committee (IBC) has a purview specific to research involving engineered genetic materials. Either way, occupational exposure to these gene delivery systems bears potential risks to the research staff.

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Engineer Genetics Clinical Research Research 52

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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ACRP blog

JUNE 7, 2023

If you hadn’t already noticed, the clinical research enterprise has well and truly entered the era of “big data,” artificial intelligence (AI), and machine learning. It also includes search and support services that help patients understand, find, and enroll in clinical trials.”

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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

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

pharmaphorum

DECEMBER 22, 2022

For instance, at a recent presentation to the Society of Quality Assurance 2022 Annual Meeting , the FDA Office of Regulatory Affairs Bioresearch Monitoring Division Director Anne Johnson emphasised that DCTs are largely reliant on electronic data integrity and therefore subject to firmly established 21 CFR Part 11 compliance.

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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

JUNE 13, 2024

In the ever-changing landscape of clinical research, patient-centricity has become a pivotal focus. Compliance: Requested features that support compliance with the regulatory bodies for the secure storage of consent forms and audit trails that store evidence of how consent was gained.

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Cloudbyz

MAY 24, 2023

Clinical trials play a crucial role in advancing medical research and developing new treatments and therapies. Clinical trial data management audits serve as a critical tool to evaluate and validate the accuracy, completeness, and integrity of the data, as well as compliance with regulatory requirements.

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