Imperical Blog

APRIL 11, 2023

This is the last in my three-part series revealing hidden causes behind delays in clinical studies. This final installment explores clinical trial retention and compliance. Part one is here, and part two is here.

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Compliance Clinical Trials Clinical Trials Trials 52

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 52

Cloudbyz

MARCH 22, 2024

However, traditional methods of data entry, particularly from diverse and unstructured documents, have long posed challenges for researchers, leading to inefficiencies, errors, and compliance risks. The Solution: Cloudbyz’s ClinExtract AI solution offers a transformative approach to data management in clinical trials.

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Clinical Trials Clinical Trials Trials Compliance 77

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 153

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

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 100

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 77

Cloudbyz

FEBRUARY 29, 2024

AI-enabled data extraction holds immense promise in expediting case processing within clinical trials, offering a transformative approach to streamline workflows and enhance efficiency. In this blog, we delve into the potential of AI in pharmacovigilance and its implications for clinical trial safety monitoring.

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Clinical Trials Clinical Trials Trials Compliance 59

Cloudbyz

MAY 24, 2023

Clinical trials play a crucial role in advancing medical research and developing new treatments and therapies. In order to ensure the reliability and validity of the data collected during these trials, rigorous data management practices and audits are necessary. Vendor Management: Verify the compliance of external vendors (e.g.,

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Compliance Clinical Trials Clinical Trials Trials 52

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

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

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 98

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 94

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 92

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 89

Cloudbyz

APRIL 14, 2023

To ensure that the implementation of ChatGPT in clinical trial operations management complies with 21 CFR Part 11 requirements, the following steps should be taken: Validation: Validate the ChatGPT system and any software that interacts with it to ensure its accuracy, reliability, and consistent intended performance.

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Compliance Clinical Trials Clinical Trials Trials 52

ACRP blog

FEBRUARY 28, 2024

Recent DOJ enforcement indictments and charges include: Three Florida medical clinic owners for fabricating clinical trial data by enrolling ineligible subjects in the trial, falsifying laboratory results and medical records, and falsely representing subjects were taking the study drug ( United States v.

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Compliance Research Clinical Research Clinical Trials 59

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 92

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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Compliance Clinical Trials Clinical Trials Trials 82

Cloudbyz

JULY 19, 2023

Clinical trials are vital in advancing medical knowledge and developing new treatments. However, ensuring participant safety is paramount throughout the trial process. It emphasizes the need for a comprehensive pharmacovigilance plan tailored to the specific trial objectives and participant population.

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Clinical Trials Clinical Trials Trials Compliance 85

Pharmaceutical Technology

APRIL 20, 2023

According to Daniel Tanner, chief commercial officer at Cerba Research, this patient centricity comes with exciting possibilities to improve trials for all stakeholders. Clinical trials were really not optimised from the perspective of the patient, site orthe sponsor; they are increasingly cost ineffective, and they take a lot of time.

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Clinical Trials Clinical Trials Trials Nurses 130

Cloudbyz

FEBRUARY 29, 2024

AI-enabled data extraction holds immense promise in expediting case processing within clinical trials, offering a transformative approach to streamline workflows and enhance efficiency. In this blog, we delve into the potential of AI in pharmacovigilance and its implications for clinical trial safety monitoring.

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Clinical Trials Clinical Trials Trials Compliance 52

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

JUNE 11, 2023

This transformation has permeated the domain of clinical trials, which is now embracing the concept of decentralized clinical trials (DCTs). This paper delves deep into the universe of DCTs, their distinctiveness from conventional trials, their inherent benefits, existing hurdles, and measures to bolster their adoption.

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Clinical Trials Clinical Trials Trials Compliance 79

Imperical Blog

DECEMBER 13, 2023

Trials, and the medical advances made through research, don’t happen without them. But here come the holidays – will your study participant compliance waver during these busy times?

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Compliance Clinical Research Trials Research 59

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 144

ACRP blog

MARCH 12, 2024

Global Disruptions, Health Equity, and Data Sharing International clinical trials are essential to evaluating the safety and efficacy of new treatments, but their success can be hampered by a variety of challenges. Pharma and biotech companies already face significant challenges in conducting international clinical trials.

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Clinical Trials Clinical Trials Trials Regulation 59

Cloudbyz

OCTOBER 19, 2023

Clinical trials are the backbone of drug development, and managing these trials efficiently is paramount. In recent years, the need for a unified clinical trial management platform has become increasingly evident. Document Management: Stores and manages trial-related documents in a centralized repository.

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Clinical Trials Clinical Trials Trials Compliance 93

Worldwide Clinical Trials

APRIL 25, 2024

However, the collection of accurate and reliable data in these pain studies presents a unique set of challenges, from the subjective nature of pain to the variability in patient compliance and assessment methodologies. Compliance Issues: Ensuring consistent patient participation in reporting pain levels post-surgery can be challenging.

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Clinical Trials Clinical Trials Compliance Trials 130

Cloudbyz

SEPTEMBER 16, 2023

Addressing data privacy and data protection concerns when implementing ChatGPT in clinical trial operations management is crucial to maintain compliance with regulations, safeguard sensitive patient information, and build trust among stakeholders. This may involve conducting regular audits and assessments to maintain compliance.

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Clinical Trials Clinical Trials Trials Compliance 59

Cloudbyz

MAY 5, 2023

Executive Summary Risk-Based Monitoring (RBM) is an approach to clinical trial monitoring that optimizes the use of resources by focusing on trial risks, with the goal of ensuring patient safety, data quality, and regulatory compliance. Introduction 2.1. Methodology of Risk-Based Monitoring 4.1.

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Clinical Trials Clinical Trials Trials Compliance 85

Imperical Blog

NOVEMBER 28, 2023

Clinical trial labeling is complex. Discover how Imperial CRS helped a client overcome some of the complexities of this critical clinical trial component. Did you know that product labels are big business?

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Clinical Trials Clinical Trials Trials Clinical Research 52

ACRP blog

JANUARY 3, 2023

During the COVID-19 pandemic, sponsors and research institutions adapted to new approaches to clinical trials, deploying technology and other tools such as remote monitoring, telemedicine, and home healthcare visits, which has helped to accelerate the evolution of decentralized clinical trials. and Canada.

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Clinical Trials Clinical Trials Trials Research 105

Cloudbyz

DECEMBER 15, 2023

Veterinary clinical trials and human clinical trials share some similarities, but there are key differences owing to the distinct nature of the subjects involved—animals versus humans. Human Trials: Human clinical trials primarily use coding systems that are specific to human medical conditions and interventions.

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Clinical Trials Clinical Trials Trials Medicine 64

FDA Law Blog

JANUARY 22, 2024

Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. Clinical Trials. By John W.M.

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Compliance Clinical Trials Clinical Trials Regulation 59

pharmaphorum

SEPTEMBER 9, 2022

The pandemic forced clinical trial sponsors to change their processes, with a more technology-driven approach and, according to a new study by Medidata, the sector is now “stronger than ever” as a result. ” The post COVID-19 has changed clinical trials for the better, says Medidata appeared first on. .

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Clinical Trials Clinical Trials Trials Compliance 98

Cloudbyz

MAY 15, 2023

Clinical trials play a critical role in medicine and healthcare, offering valuable insights that inform treatment options, drug development, and patient care. As such, the integrity of data collected during these trials is paramount. Below, we explore some practical strategies to improve data integrity in clinical trials.

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Clinical Trials Clinical Trials Trials Compliance 77