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

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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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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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

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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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 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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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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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

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 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

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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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

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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Worldwide Clinical Trials

APRIL 8, 2024

Expertly managed clinical assessments by a team with fastidious attention to detail optimizes precision and reliability and helps you successfully navigate the complex terrain of clinical research. Our cohesive approach, characterized by its agility, precision, and collaborative spirit, transforms our partnerships.

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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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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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