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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Compliance Clinical Trials Clinical Trials Clinical Research 189

Cloudbyz

AUGUST 30, 2024

In the rapidly evolving landscape of clinical research, data has become one of the most valuable assets. 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.

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Compliance Clinical Trials Clinical Trials Trials 97

ACRP blog

JANUARY 28, 2025

Collection of sensitive personal data is a cornerstone of clinical research involving drugs and medical devices. 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). View complete schedule.

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Compliance Research Clinical Trials Clinical Trials 59

Drug Patent Watch

MARCH 26, 2025

In our latest blog post, we delve into the compliance hurdles that generic drug developers face, and the valuable lessons learned from these experiences. From navigating complex regulatory landscapes to ensuring the integrity of clinical trials, the stakes are high for generic drug manufacturers.

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Generic Drugs Compliance Development Drugs 52

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. Effectively managing and storing such large datasets presents logistical challenges.

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Clinical Trials Clinical Trials Compliance Trials 94

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

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

pharmaphorum

MARCH 2, 2021

Clinical trial software facilitates clinical trials from conception to finish. For example protocol management, CRF design , metadata management, and the collection, analysis, and submission of compliant clinical study data to regulatory authorities. The aim is to get quality clinical products to the market faster.

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Clinical Trials Clinical Trials Trials Compliance 116

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. At our bioanalytical facility, we stay atop by embracing current and emerging trends.

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Clinical Trials Clinical Trials Trials Genetics 130

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

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

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

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

SEPTEMBER 12, 2024

In clinical trials, ensuring data quality is crucial for both the success of the trial and regulatory compliance. Electronic Case Report Forms (eCRFs) have become an essential tool for capturing clinical data in a structured manner. Core Types of Edit Checks 1.

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Compliance Clinical Trials Clinical Trials Trials 96

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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Life Science Clinical Trials Clinical Trials Trials 102

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

NOVEMBER 17, 2020

Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. The post Increasing patient engagement with UK clinical trials appeared first on.

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Clinical Trials Clinical Trials Trials Life Science 116

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

XTalks

DECEMBER 9, 2024

Notably, the FDA can now mandate that confirmatory trials begin before approval, ensuring proactive validation of clinical benefits. The draft also formalizes withdrawal procedures for non-compliance, including delayed studies or failure to confirm benefits.

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Clinical Trials Clinical Trials Compliance Trials 105

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. Clinical trials generate vast amounts of data, ranging from patient records and laboratory results to adverse events and regulatory submissions.

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Clinical Trials Clinical Trials Trials Compliance 104

Pharmaceutical Technology

JUNE 30, 2022

In the wake of Russia’s invasion of Ukraine, sponsors are increasingly evaluating other European countries to conduct their clinical trials. Among them, the Eastern European nation of Georgia has emerged as a key rescue country for multinational clinical trials that were put on hold due to the war. Room to grow.

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Clinical Trials Clinical Trials Trials Licensing 130

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). Advarra convened a panel of experts to discuss practical solutions for balancing compliance with efficiency in clinical trial startups.

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Clinical Trials Clinical Trials Trials Compliance 52

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.

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Medicine DNA Compliance Clinical Trials 182

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

Cloudbyz

MARCH 1, 2023

Clinical trials are a critical component of drug development in the life sciences industry. Conducting clinical trials requires significant investments of time and resources, including the management of budgets and payments. Following are the benefits of digitizing clinical trials budgets and payments.

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Clinical Trials Clinical Trials Trials Compliance 98

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

pharmaphorum

JULY 26, 2021

A lack of racial diversity in clinical trials is a long-standing, well-documented problem that contributes to the stark health inequalities that have been brought into sharp focus by COVID-19. Tackling it, however, has not been easy, thanks in no small part to the reasons being as complex as they are multi-faceted. Pillars of change.

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Clinical Trials Clinical Trials Trials Production 116

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

Cloudbyz

NOVEMBER 14, 2023

Clinical trials play a pivotal role in bringing new medical devices to market, ensuring their safety, efficacy, and compliance with regulatory standards. This can hinder the adoption of innovative approaches, such as electronic data capture (EDC) or remote monitoring, which are becoming increasingly important in clinical trials.

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Clinical Trials Clinical Trials Trials Compliance 98

Cloudbyz

APRIL 27, 2023

Regulatory automation in clinical trial operations has the potential to dramatically improve the efficiency, accuracy, and compliance of clinical trials, leading to faster development and approval of new therapies. These can range from automating routine tasks to supporting more complex decision-making processes.

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Clinical Trials Clinical Trials Trials Compliance 98

Cloudbyz

MAY 8, 2023

The clinical trial industry has seen tremendous growth in recent years, fueled by the increasing demand for new treatments, therapies, and preventive measures. In this blog, we will discuss the main reasons behind this rapid adoption and how a unified platform can revolutionize the clinical trial landscape.

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Clinical Trials Clinical Trials Trials Compliance 97

XTalks

MAY 9, 2023

Clinical trial manager jobs are vital for the development and execution of clinical trials, which are essential for developing new treatments for diseases. In this article, we discuss the job duties, education and experience requirements, outlook and salary expectations for clinical trial managers.

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Clinical Trials Clinical Trials Trials Clinical Research 98

Cloudbyz

MAY 11, 2023

Clinical trials play a vital role in bringing new therapies and treatments to patients, but they can be expensive and resource-intensive endeavors. Understanding the factors driving clinical trial costs is essential for researchers, sponsors, and other stakeholders involved in the drug development process.

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Clinical Trials Clinical Trials Trials Compliance 98

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

Cloudbyz

OCTOBER 4, 2023

Electronic Data Capture (EDC) systems are widely used in clinical trials to collect, manage, and analyze data from clinical studies. While EDC systems primarily focus on data capture and management, integrating trial budget management software within the EDC system can offer several advantages: 1.

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Clinical Trials Clinical Trials Trials Compliance 105

Cloudbyz

APRIL 30, 2023

Clinical trials are complex and time-consuming endeavors, requiring efficient management and coordination between various stakeholders. Cloudbyz’s Unified Clinical Trial Management Solution, built on the Salesforce platform, offers a comprehensive, customizable, and secure platform for streamlining clinical trial operations.

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Clinical Trials Clinical Trials Trials Laboratory Information Management System 98

Cloudbyz

MARCH 31, 2024

The landscape of clinical trial management is undergoing a significant transformation, driven by the complex demands of modern medical research. As we delve into the challenges posed by point systems, it becomes clear that a platform approach is not just beneficial but essential for the future of clinical trials.

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Clinical Trials Clinical Trials Trials Compliance 103