ACRP blog

JANUARY 28, 2025

However, if the personal data relates to European Union (EU) or United Kingdom (UK) residents, this raises particular legal and compliance issues due to the General Data Protection Regulation (GDPR). Other laws to keep in mind are the Clinical Trials Regulation and Medical Devices Regulation. View complete schedule.

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Compliance Research Clinical Trials Clinical Trials 59

ACRP blog

FEBRUARY 11, 2025

The Health Care Compliance Association (HCCA), a nonprofit membership organization supporting healthcare compliance professionals, was founded, in part, to be your eyes and ears for compliance updates and regulatory changes. Group discounts are available; bring your team for shared learning!

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Compliance Clinical Research Research Regulation 59

Bio Pharma Dive

JULY 3, 2023

iliomad Health Data can help you maintain GDPR compliance. What is the GDPR and why does it matter to your life sciences company.

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Life Science Compliance Trials 246

Cloudbyz

AUGUST 30, 2024

Clinical trials are the backbone of medical advancements, but their complexity and the regulatory environment pose significant challenges to researchers, sponsors, and clinical trial managers. Managing these trials efficiently while ensuring compliance with stringent regulatory standards is paramount to their success.

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Compliance Clinical Trials Clinical Trials Trials 93

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. Incorrect billing can result in federal and state violations as well as financial penalties. “To

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Compliance Clinical Trials Clinical Trials Trials 111

Rethinking Clinical Trials

DECEMBER 18, 2024

This was a multisite, practice-based, comparative effectiveness randomized clinical trial conducted at six public hospitals and three academic medical centers in New York City. Sustainment can be an Achilles Heel for embedded trials, as programs that have been shown to be successful arent always covered by insurance.

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Nurses Clinical Trials Clinical Trials Trials 100

Cloudbyz

AUGUST 30, 2024

Clinical Trial Management Systems (CTMS) play a pivotal role in managing this data, encompassing everything from patient information and trial protocols to sensitive medical records and regulatory documents. Given the critical nature of this data, ensuring its security and compliance with regulatory standards is paramount.

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Compliance Clinical Trials Clinical Trials Trials 97

Worldwide Clinical Trials

APRIL 3, 2024

Are you aware of the challenges you must address for a successful radiopharmaceutical trial? Enhancing Patient Participation in Radiopharmaceutical Trials Patient recruitment is a critical yet challenging part of radiopharmaceutical trials.

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Trials Clinical Trials Clinical Trials Compliance 204

XTalks

DECEMBER 9, 2024

The new framework allows the FDA to require confirmatory trials to be underway before or shortly after approval, potentially reducing the time to confirm a therapys clinical impact from several years to as little as two or three years. Special cases highlighted include rare diseases and conditions with long courses or infrequent outcomes.

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Clinical Trials Clinical Trials Compliance Trials 105

Cloudbyz

JUNE 16, 2023

Clinical trials are crucial for advancing medical research and developing innovative treatments. Effective clinical trial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access. Data Complexity: Clinical trial data often comes in diverse formats, such as text, images, audio, and video.

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Clinical Trials Clinical Trials Compliance Trials 94

Worldwide Clinical Trials

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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Trials Clinical Trials Clinical Trials Regulation 200

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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Clinical Trials Clinical Trials Compliance Trials 98

Cloudbyz

SEPTEMBER 12, 2024

In clinical trials, ensuring data quality is crucial for both the success of the trial and regulatory compliance. This unified guide explores both foundational and advanced types of edit checks, highlighting their importance in maintaining high-quality data in clinical trials. Core Types of Edit Checks 1.

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Compliance Clinical Trials Clinical Trials Trials 96

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. In this blog, we will explore how generative AI can revolutionize electronic Trial Master File (eTMF) management, unlocking new levels of efficiency, quality, and compliance.

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Compliance Clinical Trials Clinical Trials Trials 96

Worldwide Clinical Trials

JANUARY 6, 2025

From instrument integration to data processing, automation ensures regulatory compliance and enhanced scalability, which is necessary for the increasing demand for novel treatments across therapeutic areas. Biomarkers support adaptive trial designs, allowing modifications based on interim results to optimize study outcomes.

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Clinical Trials Clinical Trials Trials Genetics 130

Bio Pharma Dive

MAY 3, 2021

Learn why clinical trial sponsors are moving to BYOD for a better patient experience, greater compliance, and higher-quality data – all at a lower cost.

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Clinical Trials Clinical Trials Trials Compliance 130

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2024

Biopharmaceutical involves substantial investments in research, clinical trials, regulatory compliance, and manufacturing. Hence the affordability of these medicines are a complex issue, said Dr Amaresh Tumbagi, Karnataka additional drugs controller.

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Production Clinical Trials Clinical Trials Compliance 188

pharmaphorum

MARCH 2, 2021

Clinical trial software facilitates clinical trials from conception to finish. Traditionally spreadsheets have been used to record and manage all the various aspects of clinical trials. Traditionally spreadsheets have been used to record and manage all the various aspects of clinical trials. What is an EDC system?

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Clinical Trials Clinical Trials Trials Compliance 116

Worldwide Clinical Trials

JUNE 13, 2024

Pharmacogenomics (PGx), the study of how genes affect a person’s response to drugs, has brought significant changes to the clinical trial industry. Patient Compliance One of the most important findings of the study was the difference in patient compliance between the two sample collection methods.

Medicine 182

Medicine DNA Compliance Clinical Trials 182

Cloudbyz

OCTOBER 30, 2023

Clinical trials are vital for advancing medical research, but they involve complex processes and a multitude of documents that need careful management and oversight. The Electronic Trial Master File (eTMF) system is a cornerstone of clinical trial document management, providing a digital repository for essential trial documents.

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Clinical Trials Clinical Trials Trials Compliance 105

Worldwide Clinical Trials

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials. Additionally, consider the locations of your trial; if it is multiregional, you can start planning for your overall product approval strategy.

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Clinical Research Trials Research Clinical Trials 173

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

Advarra

NOVEMBER 14, 2024

In an era where clinical trials are increasingly global, it’s more imperative than ever to leverage international expertise. Data and safety monitoring boards (DSMBs), also known as data monitoring committees (DMCs), play a critical role in overseeing a clinical trial’s safety and efficacy.

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Clinical Trials Clinical Trials Trials Clinical Research 97

Camargo

JUNE 23, 2021

While the COVID-19 pandemic has accelerated innovation in many areas, including clinical trial design, many recent advancements were already in motion before 2020 as sponsors and CROs sought to improve the patient journey and encourage trial participation. Planning of Decentralized Clinical Trials. Technology.

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Clinical Trials Clinical Trials Trials Nurses 143

Cloudbyz

MAY 17, 2024

This Act is poised to significantly change the clinical trials landscape within the life sciences sector. These systems must undergo thorough conformity assessments to verify their compliance with safety, transparency, and accountability standards, thereby boosting the reliability and integrity of clinical trial data.

Life Science 102

Life Science Clinical Trials Clinical Trials Trials 102

Worldwide Clinical Trials

MARCH 20, 2024

One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinical trials.

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Clinical Trials Clinical Trials Trials Genetics 130

ACRP blog

OCTOBER 22, 2024

The clinical research industry plays a vital role in advancing medical knowledge and improving healthcare; however, the increasing complexity of clinical trials has created a perfect storm of challenges for clinical research sites, posing significant risks to the efficiency, effectiveness, and sustainability of clinical trials at large.

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Trials Clinical Research Clinical Trials Clinical Trials 59

Cloudbyz

MARCH 11, 2024

Electronic Trial Master Files (eTMFs) play a pivotal role in the clinical trial process, serving as repositories for essential documents and data that demonstrate compliance with regulatory requirements and ensure the integrity of trial conduct.

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Trials Compliance Clinical Trials Clinical Trials 105

Cloudbyz

APRIL 25, 2023

This comprehensive guide delves into the essentials of pharmacovigilance regulatory reporting, highlighting its significance in maintaining drug and device safety, and ensuring compliance with regulatory requirements. Different types of reports have specific timelines for submission, and delays may result in regulatory actions or penalties.

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Compliance Clinical Trials Clinical Trials Manufacturing 97

Cloudbyz

SEPTEMBER 12, 2024

Clinical trials are complex endeavors, requiring the meticulous coordination of numerous stages, regulatory frameworks, and ongoing management. From planning to post-trial activities, ensuring compliance, maintaining data integrity, and safeguarding patient safety are critical throughout the trial’s lifecycle.

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Clinical Trials Clinical Trials Trials Compliance 91

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 18, 2024

In a move aimed at enhancing compliance and facilitating smoother trade operations, the Directorate General of Foreign Trade (DGFT) has introduced stringent policy conditions for the export of chitin and chitosan derivatives.

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Regulation Compliance Marketing Clinical Trials 184

Pharmaceutical Technology

DECEMBER 12, 2022

Clinical trial results in obese patients showed that by Day 85 of the study, participants in the multiple ascending doses (MAD) cohort showed a mean percentage change in body weight of -14.5% AMG-133, which has completed Phase I of development for obesity (NCT04478708), is of paramount interest as it is a first-in-class therapy for obesity.

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Compliance Insulin Marketing Trials 264

Cloudbyz

NOVEMBER 13, 2023

In the ever-evolving landscape of healthcare and medical technology, the importance of conducting efficient and well-managed clinical trials cannot be overstated. In this blog, we will explore why medical technology companies need unified clinical trial management solutions and how these solutions can significantly impact their success.

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Clinical Trials Clinical Trials Trials Compliance 104

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 105

Clinical Trials Clinical Trials Trials Compliance 105

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 12, 2024

In a significant move to enhance trade facilitation and streamline compliance with foreign trade regulations, the Directorate General of Foreign Trade (DGFT), under the Ministry of Commerce & Industry, has announced amendments to the export obligation period for several import items.

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Compliance Regulation Drugs Clinical Trials 188

Advarra

FEBRUARY 4, 2025

At a busy research site, a clinical trial is ready to launch but its stuck in limbo over a single paragraph in the informed consent form (ICF). While the trial waits for approval, patients who are eager for a new treatment face delay. Language relating to the potential cost of participation. Age isnt the only factor to consider.

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Clinical Trials Clinical Trials Trials Compliance 52

Cloudbyz

MARCH 19, 2023

Decentralized Clinical Trial Management is a new approach to conducting clinical trials that leverages decentralized technologies such as blockchain, smart contracts, and distributed computing to streamline the clinical trial process. Additionally, all data is encrypted, making it secure from cyber threats.

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Clinical Trials Clinical Trials Trials Compliance 98