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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Cloudbyz

SEPTEMBER 11, 2024

This prestigious recognition positions Cloudbyz among the top performers in delivering intuitive and scalable EDC solutions to life sciences organizations worldwide. This prestigious recognition positions Cloudbyz among the top performers in delivering intuitive and scalable EDC solutions to life sciences organizations worldwide.

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Life Science Clinical Trials Clinical Trials Compliance 52

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. Embedding the patient voice not only in research, but everything they do. Gareth has been with the Clinical Research Network since 2009.

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Clinical Trials Clinical Trials Trials Life Science 116

Cloudbyz

OCTOBER 25, 2023

Naperville, Illinois – October 24, 2023 : Cloudbyz, an innovative digital clinical research solutions provider, today announced a new partnership with SPAR Solutions who provide a complete range of customer engagement solutions covering sales, marketing, service, and communities.

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Life Science Clinical Trials Clinical Trials Compliance 104

pharmaphorum

DECEMBER 22, 2022

The life sciences industry is flexing towards innovation in new areas, faster than ever before, and increasing patient care in astonishing ways. Prediction 2: More clinical trial services will become remote, beyond just patient monitoring. Decentralised oncology trials, for example, have shown actual predictive outcome value.

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Cloudbyz

SEPTEMBER 28, 2023

In the ever-evolving world of clinical research and life-sciences, the efficient and accurate collection of data is paramount. Researchers and clinical trial professionals are constantly seeking innovative solutions to streamline the data collection process, improve data quality, and enhance overall efficiency.

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Life Science Clinical Research Clinical Trials Clinical Trials 111

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

XTalks

DECEMBER 20, 2023

In 2023, there were significant advancements and notable trends in the life sciences. Xtalks compiled a list of its top life science news and trends of 2023, which provided readers with the latest developments, information and expert insights across life science industries, including pharma, biotech and medical device.

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XTalks

OCTOBER 22, 2024

Additionally, pharmacological interventions can introduce side effects that must be carefully managed to ensure patient health, compliance and data integrity. Data Integrity and Clinical Outcomes Genetic, lifestyle and metabolic differences mean that obesity treatments may not work uniformly across participants.

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Clinical Trials Clinical Trials Trials Clinical Research 105

XTalks

NOVEMBER 15, 2024

MDS are a group of blood disorders caused by abnormal development of blood cells in the bone marrow. These disorders result in a shortage of healthy blood cells, leading to symptoms such as fatigue, weakness, infections and easy bruising or bleeding.

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Trials HR Immune Response FDA Approval 105

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

Cloudbyz

MARCH 28, 2023

This solution is designed to meet the unique needs of clinical research organizations (CROs) and pharmaceutical companies, offering a range of features to help them streamline their operations, manage clinical trials, and ensure compliance with regulatory requirements.

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Life Science Clinical Trials Clinical Trials Compliance 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

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

XTalks

JULY 25, 2024

By reducing the burden on patients and improving their experience, YPrime enhances patient engagement and compliance, which is crucial for trial success. Advice for Industry Leaders Hughes’ advice to other leaders in the life sciences industry is rooted in humility and continuous improvement.

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Clinical Research Clinical Trials Clinical Trials Research 64

XTalks

DECEMBER 19, 2024

Developing those relationships within the community so that you are not dropping in just for your clinical research study, but you have ongoing patient community engagement, is important. Once patients join, we must make it easy for them to participate, support their compliance and listen to their experiences to improve future trials.

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Clinical Trials Clinical Trials Trials Research 97

Cloudbyz

JANUARY 20, 2021

☰ The need for a centralized platform for clinical research study. Clinical research teams are constantly challenged to do more with fewer resources. This has led to an extreme delay in the research outcome. This has led to an extreme delay in the research outcome. Compliance. Contact us.

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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

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.

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Clinical Research Research Gerontology Clinical Trials 40

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

VirTrial

JANUARY 10, 2020

The program is a new breed of telemedicine platform customized specifically for hybrid decentralized clinical trials (DCT) in the clinical research industry. Our entire management team has spent years in the clinical research industry and we stay closely connected to the community to understand their evolving needs.

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Clinical Trials Clinical Trials Clinical Research Pharma Companies 97

Cloudbyz

JANUARY 13, 2021

. ☰ Decentralized Trials will dominate Clinical Research space in 2021. Decentralized clinical trials or DCT have become the new norm for the life sciences industry. So, DCT will have a formidable impact on shaping up the clinical landscape in 2021in various aspects. Compliance. Jan 13, 2021.

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Clinical Research Trials Research Clinical Trials 52

Cloudbyz

APRIL 2, 2021

Together, they provide an integrated platform for Clinical Research with CTMS, eTMF, EDC, Pharmacovigilance & Safety and EQMS to enable seamless collaboration, to improve efficiency and drive digital transformation in Life Sciences R&D. For more information contact visit www.cloudbyz.com.

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Life Science Clinical Research Clinical Trials Clinical 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.

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Life Science Clinical Research Compliance Clinical Trials 52

Cloudbyz

OCTOBER 25, 2023

Naperville, Illinois – October 25, 2023 : Cloudbyz, an innovative digital clinical research solutions provider, today announced a new partnership with SPAR Solutions who provide a complete range of customer engagement solutions covering sales, marketing, service, and communities.

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Life Science Clinical Trials Clinical Trials Compliance 52

The Pharma Data

NOVEMBER 10, 2020

Weiner, chairman of the scientific advisory board of Tiziana Life Sciences, commented: “We understand that this will be the first-ever study with ‘take-home’ capsules of any mAb for immunotherapies for human diseases. However, severe toxicities and poor patient compliance limit the long-term use for intravenous immunotherapies.

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Life Science Clinical Trials Clinical Trials Trials 40

ACRP blog

JULY 24, 2024

Study sites and sponsors could both benefit from learning to convert data from investigator meetings and other sources into meaningful metrics and actionable insights that can impact business strategy, a seasoned observer of the clinical research enterprise says.

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Clinical Trials Clinical Trials Clinical Research Life Science 64

Cloudbyz

NOVEMBER 9, 2021

an innovative digital solutions provider for organizations that specialize in Clinical Research, Life Sciences, and Biopharmacy, announces receiving the ISO 9001:2015 certification. CHICAGO , Nov. 9, 2021 /PRNewswire/ — Cloudbyz Inc., ” Mr. .”

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Life Science Clinical Trials Clinical Trials Clinical Research 52

Cloudbyz

AUGUST 26, 2024

Implementing a Clinical Trial Management System (CTMS) is a critical step for any life sciences organization aiming to enhance the efficiency, compliance, and oversight of their clinical trials. This includes understanding the current challenges in trial management, regulatory compliance, and data integrity.

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Clinical Trials Clinical Trials Trials Compliance 52

pharmaphorum

OCTOBER 27, 2022

To help ensure compliance, it is advisable for companies to establish procedures to assess and verify IT security of social media and digital channels, and to review and monitor company activities, content, and materials. About the authors.

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Life Science Medicine Regulation Compliance 98

XTalks

MAY 6, 2022

In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinical trials. Clinical Data Pipeline for Data Review and Analyses.

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Clinical Trials Clinical Trials Trials Life Science 98

XTalks

DECEMBER 4, 2023

Matthew Confeld, PharmD, PhD Assistant Director, Clinical Research Methodology, Worldwide Clinical Trials In this Xtalks Spotlight edition, Xtalks spoke with Matthew Confeld, PharmD, PhD, Assistant Director of Clinical Research Methodology at Worldwide Clinical Trials , about Project Optimus and what it means for oncology programs.

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Development Drugs Clinical Trials Clinical Trials 111

XTalks

OCTOBER 18, 2024

Why Target PIK3CA Mutations? PIK3CA mutations are a key driver of treatment resistance in HR-positive, HER2-negative breast cancer.

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HR FDA Approval Hormones Compliance 105

pharmaphorum

FEBRUARY 4, 2021

Adams believes this positive start to the year is a sign that life science and medical device companies are looking for expert partners who understand the operational and regulatory challenges facing them and can deliver scalable solutions that meet their unique requirements. “It

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Life Science Clinical Trials Clinical Trials Regulation 52

pharmaphorum

MAY 27, 2022

The possibilities are endless, and in the context of trial participation and access to medicine technologies could assist: Reduced assessment times and hence increased patient compliance. There is a huge opportunity for pharma companies to capitalise on by focusing on increased DEI in clinical trials. What comes next?

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pharmaphorum

MARCH 21, 2022

Over two years ago Formedix joined forces with eClinical Solutions , a leading provider of solutions for collecting, standardizing and reporting clinical research data. This functionality offered the perfect synergy with our ryze Clinical Metadata Repository (CMDR) and automation platform.

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Clinical Trials Clinical Trials Trials Compliance 98

ACRP blog

APRIL 5, 2023

AI is increasingly important in drug discovery and development as well as clinical trials, operations, pharmacovigilance, and many other areas.” This has led to the emergence of a new ‘pharmaceutical intelligence’ that has allowed the industry to move away from traditional, slow-moving, and costly processes,” Lyons writes. “AI

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