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?”.

Clinical Research 105

Clinical Research Research Clinical Trials Clinical Trials 105

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

Clinical Research 98

Clinical Research Research Clinical Trials Clinical Trials 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. Covid-19: adversity leading to improvements.

Clinical Research 103

Clinical Research Research Clinical Trials Clinical Trials 103

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.

Clinical Research 52

Clinical Research Research Compliance Clinical 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.

Life Science 52

Life Science Clinical Trials Clinical Trials 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.

FDA Compliance 52

FDA Compliance Compliance Clinical Trials Clinical Trials 52

Cloudbyz

MAY 17, 2022

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 Clinical Research Regulation Clinical Trials 52

Cloudbyz

MAY 17, 2022

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

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.

Compliance 88

Compliance Clinical Trials Clinical Trials Trials 88

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.

Compliance 73

Compliance Clinical Trials Clinical Trials Trials 73

Cloudbyz

MAY 17, 2022

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

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.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

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.

Clinical Research 59

Clinical Research Research Clinical Trials Clinical Trials 59

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.

Clinical Trials 91

Clinical Trials Clinical Trials Trials Compliance 91

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.

Compliance 52

Compliance Clinical Trials Clinical Trials Trials 52

Cloudbyz

MAY 15, 2024

Selecting the right eSource system for clinical trials is a critical decision that can significantly impact the efficiency and success of your research projects. Data Integrity and Compliance ERES Compliance: Confirm the system complies with Electronic Records/Electronic Signatures (ERES) regulations such as FDA 21 CFR Part 11.

Clinical Trials 52

Clinical Trials Clinical Trials Compliance Regulation 52

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. Let’s delve into how these solutions can accelerate research and bring products to market faster.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

XTalks

MAY 9, 2023

As the demand for clinical trials continues to grow, so does the need for skilled professionals who can manage complex trial operations and ensure that studies are conducted in compliance with regulatory requirements. If you’re considering a career in clinical research, read on to learn more about this rewarding career.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

ACRP blog

JANUARY 30, 2024

“We’re seeing significant innovations in the medical product development industry, and true innovation can cause some consternation in such a highly regulated sector,” says David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, at the U.S.

Trials 59

Trials Clinical Trials Clinical Trials Clinical Research 59

Cloudbyz

SEPTEMBER 19, 2023

Introduction Clinical research is a complex and highly regulated field where meticulous attention to detail is paramount. This cost-saving can be redirected towards other critical aspects of clinical research. This is crucial for regulatory compliance and audit purposes. GDPR, HIPAA) is paramount.

Compliance 84

Compliance Clinical Trials Clinical Trials Clinical Research 84

VirTrial

OCTOBER 14, 2020

The training and certification initiative aims to provide sustainable study and patient opportunities for investigator sites, while demonstrating telemedicine technology competencies in the eyes of international regulators. “VirTrial was created with sites in mind from the start,” says Kim Kundert, Executive Vice President.

Compliance 98

Compliance Clinical Research Clinical Trials Clinical Trials 98

Worldwide Clinical Trials

APRIL 3, 2024

Complying with Unique Radiopharmaceutical Regulations The regulatory landscape for radiopharmaceuticals is intricate, reflecting the drugs’ complexity. Keeping abreast of changes in regulatory frameworks guarantees compliance and minimizes regulatory-related delays.

Trials 201

Trials Clinical Trials Clinical Trials Compliance 201

Advarra

MARCH 5, 2024

While the regulations governing clinical research refer to “noncompliance” several times, the term is not actually defined in the regulations. Understandably, this can cause confusion for researchers working with multiple IRBs. The post Reporting to the IRB: Investigator Noncompliance appeared first on Advarra.

Regulation 52

Regulation Research Clinical Research Compliance 52

WCG Clinical

NOVEMBER 20, 2023

Why Was My Research Submission/Protocol Deferred? Research submission/protocols are deferred when the Board is unable to determine that the regulatory criteria for approval are met ( 21 CFR§56.111 and 45 CFR§46.111 ). If FDA determines that the research does not need an IND, FDA will issue a statement to that effect.

Research 52

Research Clinical Trials Clinical Trials Production 52

Advarra

JUNE 14, 2022

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) regularly examines us as part of our accreditation maintenance. Annual reports to confirm ongoing compliance and maintain accreditation. Compliance with Applicable Regulations. Additionally, many of our clients audit the IRB. Site visits.

Compliance 52

Compliance Regulation Research Clinical Research 52

Cloudbyz

FEBRUARY 20, 2024

Lack of flexibility: Rigid systems struggle to adapt to changing regulations, trial protocols, and industry best practices. This can lead to compliance issues, wasted resources, and delays. This is particularly beneficial for CTMS, which requires reliable, on-demand access to manage complex clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials Compliance Trials 52

Cloudbyz

APRIL 6, 2023

Naperville, Illinois – April 6, 2023 : Cloudbyz, an innovative digital clinical research solutions provider, today announced a new partnership with Odaseva, the leading Enterprise Data Protection Platform built specifically to address the needs of the largest Salesforce customers.

Life Science 52

Life Science Compliance Clinical Research Clinical Trials 52

Cloudbyz

MARCH 3, 2023

Mid-size Clinical Research Organizations (CROs) play a significant role in the pharmaceutical and biotech industry by providing various services such as study design, clinical trial management, data management, and biostatistics. Regulatory Compliance Compliance with regulatory requirements is critical for CROs.

Compliance 79

Compliance Branding Packaging Packaging 79

Clinical Trial Podcast

JUNE 6, 2021

Clinical trials are conducted in compliance with regulations. Simply stated, you need a clinical and regulatory strategy when it comes to conduct of clinical trials for medical devices. As a clinical researcher, there have been times I’ve felt lost because I did not understand the regulatory framework.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Regulation 59

Cloudbyz

MARCH 13, 2023

Ensure Compliance with Regulations and Guidelines: Clinical trial data management should be in compliance with regulatory requirements and industry standards. The International Council for Harmonisation (ICH) guidelines provide a framework for data management in clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

VirTrial

FEBRUARY 12, 2024

Clinical trials continue to become more complex and whilst there is extensive evidence demonstrating the improvement of data quality through electronic collection of Clinical Outcomes Assessment (eCOA) data, trial complexity can place additional burden on clinical research sites.

Trials 52

Trials Clinical Trials Clinical Trials Clinical Research 52

ACRP blog

AUGUST 23, 2023

The ICH represents a collaboration of FDA, the European Medicines Agency (EMA), and Japan’s health regulatory authority designed, in part, to streamline medical research across their regional and multinational activities. and by ICH, do you think is it possible that DCTs will be regulated significantly differently in these settings?

Regulation 98

Regulation Clinical Trials Clinical Trials Trials 98

Cloudbyz

FEBRUARY 21, 2023

Quality Management Systems (QMS) are an essential component of clinical operations as they manage the quality of clinical research. QMS define, document, and implement standard operating procedures and guidelines that ensure clinical trials comply with regulatory requirements and industry standards.

Clinical Trials 52

Clinical Trials Clinical Trials Compliance Trials 52

ACRP blog

NOVEMBER 16, 2023

You may be happily using ChatGPT to produce meeting minutes or literature reviews, and your children may be secretly using it to complete essays and term papers, but is the world of medical research ready to have such artificial intelligence (AI) tools producing informed consent forms (ICFs) for clinical trial participants?

Compliance 64

Compliance Clinical Trials Clinical Trials Trials 64

ACRP blog

MARCH 21, 2023

Food and Drug Administration’s (FDA’s) requirements for clinical research during the COVID-19 pandemic, including adoption of decentralized clinical trial (DCT) elements such as novel monitoring models, shipping investigational products to patients’ homes, and changes to document-sharing procedures.

Compliance 59

Compliance Clinical Research Clinical Trials Clinical Trials 59

Worldwide Clinical Trials

NOVEMBER 10, 2023

 Instead, the medical community and regulating agencies need to balance all aspects when making decisions, working in partnership with their patients. Collaborating From going to clinic visits and arranging a friend or caregiver to take you to the drive itself and self-care preparation, it’s truly a horrible position to be in. 

Clinical Trials 184

Clinical Trials Clinical Trials Trials Compliance 184

Advarra

JANUARY 11, 2024

The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines.

Vaccination 52

Vaccination Vaccine Protein Antibody 52