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. Real-time Quality Assurance: Quality control and assurance are crucial aspects of clinical trial management.

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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.

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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 The post How to Weather the Clinical Research Talent Recruitment Storm appeared first on ACRP.

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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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ACRP blog

OCTOBER 24, 2024

She will co-lead an ACRP 2025 Workshop on “Project Management Basics for Clinical Research” next April in New Orleans along with Beth Bieze, CCRC, ACRP-PM, FACRP. Nikki Skirvin, CCRC, ACRP-PM, who works remotely based in Tennessee as a Senior Project Manager for a contract research organization (CRO).

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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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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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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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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.

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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.

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Compliance Clinical Research Regulation Clinical Trials 52

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 Trials Clinical Trials Trials Compliance 105

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.

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Compliance Regulation Clinical Research 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 Regulation Compliance 52

Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. The EU AI Act’s implications extend into clinical research, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms.

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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.

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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.

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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. Some are recent undergraduates and others mid-career professionals or clinicians.

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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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Advarra

FEBRUARY 13, 2024

Every day, clinical research organizations work to deliver a seamless user experience for their staff, while also providing robust security measurements to protect their data and stay compliant. SSO also has the ability to enhance user accountability and compliance within an organization.

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Worldwide Clinical Trials

AUGUST 9, 2024

Advantages and Operational Challenges in Adaptive MRCTs Adaptive trial designs are gaining popularity in clinical research due to their ability to improve trial efficiency and uphold ethical standards, resulting in faster and more reliable outcomes.

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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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Cloudbyz

APRIL 19, 2023

Introduction: The new European Union (EU) Clinical Trial Regulation (CTR), Regulation (EU) No 536/2014, came into force in January 2022, replacing the previous EU Clinical Trials Directive (2001/20/EC). This aims to increase transparency, reduce publication bias, and promote data sharing among researchers.

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Clinical Trials Clinical Trials Regulation Trials 52

Pharmaceutical Technology

JULY 29, 2022

Recording patient consent is a fundamental pillar of clinical research. These countries either have a guidance document that was put out by the regulatory authority, or the ethics committee itself will have eConsent guidance based on what the national signature laws, data privacy laws, and clinical trial regulations will allow.".

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ProRelix Research

JUNE 27, 2024

In the United States, The Food and Drug Administration (FDA) regulates and oversees clinical trials of food and dietary supplements and develops various regulations and guidelines for their use. The […] The post Food and Dietary Supplements Clinical Trials Regulations in USA appeared first on ProRelix Research.

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Clinical Trials Clinical Trials Regulation Trials 52

Cloudbyz

APRIL 20, 2023

The European Union (EU) Clinical Trial Regulation (CTR) No 536/2014, which came into effect in January 2022, has significantly changed the clinical trial landscape in the EU. It streamlines and harmonizes the clinical trial application process while maintaining high standards of patient safety and data quality.

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Clinical Trials Clinical Trials Regulation 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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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.

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Clinical Trials Clinical Trials Trials Clinical Research 98

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.

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Clinical Trials Clinical Trials Compliance Clinical Research 104

Cloudbyz

AUGUST 12, 2024

Evaluate different EDC vendors based on factors such as system functionality, ease of use, scalability, integration capabilities, and compliance with regulatory standards. Ensure Regulatory Compliance Compliance with regulatory requirements, such as FDA 21 CFR Part 11, is non-negotiable when implementing an EDC system.

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Cloudbyz

MAY 24, 2023

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. Regulatory Compliance: Verification of compliance with applicable regulatory guidelines (e.g.,

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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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Cloudbyz

AUGUST 30, 2024

Let’s be real for a second—clinical research systems aren’t exactly everyone’s favorite topic but if you’re in the trenches of clinical research, you know they can make or break your day. Seamless Integration: This tool is fully integrated into your CTMS system and embedded across your entire clinical research process.

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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

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.

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XTalks

NOVEMBER 29, 2024

The lack of existing treatments amplifies the unmet need for a viable therapy. Govorestat is the first therapy evaluated specifically for this ultra-rare condition.

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WCG Clinical

JULY 31, 2024

The NPRM was issued in response to the legislative mandate under the 21 st Century Cures Act for the FDA to harmonize its regulations as much as possible with the 2018 revisions to the Common Rule and changes to Cooperative Research under 45 CFR 46.114. The post Demystifying FDA Processes: Why Do Changes in Regulations Take so Long?

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Regulation Research Clinical Research Compliance 52

pharmaphorum

MAY 5, 2022

The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization that aims to maximise the impact of clinical research data by establishing and promoting the use of data standards. Basically, these standards make clinical data easier to understand and interpret. “We

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