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

Advarra

JANUARY 13, 2023

New privacy regulations seem to form every few months, especially with individual U.S. states adopting their own privacy regulations (e.g., Endpoint adjudication committees (EACs), also called clinical event committees (CECs), receive potentially identifiable research data from all over the world.

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Regulation Clinical Trials Clinical Trials Trials 52

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. From legal considerations to data privacy regulations, the challenges facing these teams can be daunting.

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Clinical Trials Clinical Trials Trials Regulation 59

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 113

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.

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Clinical Trials Clinical Trials Trials Compliance 59

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 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

APRIL 14, 2023

21 CFR Part 11 is a regulation set by the US Food and Drug Administration (FDA) that outlines the criteria for electronic records and electronic signatures to be considered as reliable, trustworthy, and equivalent to paper records. Address any identified issues promptly and maintain records of review findings and corrective actions taken.

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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

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

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 69

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 72

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: Requires informed consent directly from the human participants or their legal representatives.

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Clinical Trials Clinical Trials Trials Medicine 64

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

MARCH 13, 2023

Clinical trial data management involves collecting, processing, analyzing, and reporting data from clinical trials in a systematic and efficient manner. Effective data management is critical for ensuring the safety and efficacy of the tested intervention and maintaining the integrity of the trial results.

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Clinical Trials Clinical Trials Trials Compliance 52

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.

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Clinical Trials Clinical Trials Trials Compliance 83

Cloudbyz

APRIL 20, 2023

Clinical trials are an essential part of the drug development process. The success of a clinical trial depends on the efficient management of the study, which is the responsibility of the sponsor. In this blog post, we will discuss the roles and responsibilities of a sponsor in clinical trial management.

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Clinical Trials Clinical Trials Trials Compliance 52

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 68

CTTI (Clinical Trials Transformation Initiative)

JANUARY 10, 2024

Timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov allows access to current research and evidence for all partners in the clinical trials enterprise, including patients, providers, sponsors and investigators, regulators, payers, and health system leaders.

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Clinical Trials Clinical Trials Trials Compliance 65

pharmaphorum

MAY 27, 2022

This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. The same principles are increasingly being applied to clinical trials to improve diversity, mitigate bias, and reinforce inclusion in clinical trials.

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Clinical Trials Clinical Trials Trials Packaging 78

ACRP blog

FEBRUARY 26, 2024

My office manages all of the cancer clinical trials for all types of cancer. We owe all of it to clinical trials—to the people who volunteer to use their own bodies to further the science, and to the researchers who tirelessly work to find new ways to stop what once seemed unstoppable. They’re saving my life.

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Clinical Trials Clinical Trials Trials Nurses 59

Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. Like any complex and highly regulated industry, the existence of non-conformities and deviations is inevitable.

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Compliance Clinical Development Development Clinical Trials 52

Imperical Blog

SEPTEMBER 7, 2023

Avoiding “Customs Chaos” in Clinical Trials Means Working Closely with Your Importer of Record Many global clinical trial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Imperical Blog

SEPTEMBER 7, 2023

Avoiding “Customs Chaos” in Clinical Trials Means Working Closely with Your Importer of Record Many global clinical trial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

MAY 17, 2022

Until recently, clinical trials have been performed in a mostly paper-based processes. 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

Worldwide Clinical Trials

APRIL 3, 2024

By emphasizing transparency and patient autonomy, trials can maintain ethical standards while fostering trust and participation. Complying with Unique Radiopharmaceutical Regulations The regulatory landscape for radiopharmaceuticals is intricate, reflecting the drugs’ complexity.

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Trials Clinical Trials Clinical Trials Compliance 198

Cloudbyz

MARCH 17, 2023

Good Clinical Practice (GCP) is an international standard that outlines ethical and scientific quality requirements for designing, conducting, recording, and reporting clinical trials involving human subjects. Deviations from the protocol can impact the study’s integrity and raise ethical concerns.

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Clinical Trials Clinical Trials Trials Life Science 52

Advarra

SEPTEMBER 8, 2022

As electronic documentation usage increases in clinical trials, organizations must make sure they’re still protecting participants’ health and safety without sacrificing quality or efficacy. One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations.

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Compliance Regulation Packaging Packaging 52

Advarra

DECEMBER 14, 2023

Sponsor study team members and research sites each play a critical role in clinical trial executions. Despite the consequences, the FDA has reported a failure rate of 36% in clinical trial site inspections over the past five years. Inadequate and Inaccurate Records (21 CFR 312.62(b))

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Compliance Trials Clinical Trials Clinical Trials 52

Cloudbyz

MAY 24, 2023

This is where unified clinical trial management solutions come into the picture, enhancing efficiency, reducing time to market, and ensuring high-quality, scientifically validated consumer products. A delay in trials or approval can significantly impact the product’s success and the company’s bottom line.

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Clinical Trials Clinical Trials Production Trials 52

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. This report helps regulatory authorities monitor the safety of investigational drugs during clinical development.

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Compliance Clinical Trials Clinical Trials Manufacturing 73

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 113

XTalks

SEPTEMBER 25, 2023

Elon Musk’s Neuralink has begun its recruitment for human clinical trials, a move that has been met with significant debate. They embarked on a clinical study to map human brain signals this past June. They launched their clinical trial, COMMAND, in March of this year.

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Clinical Trials Clinical Trials Trials Compliance 69

Cloudbyz

MAY 17, 2022

Until recently, clinical trials have been performed in a mostly paper-based processes. 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.

Compliance 52

Compliance Clinical Research Regulation Clinical Trials 52

Cloudbyz

MAY 17, 2022

Until recently, clinical trials have been performed in a mostly paper-based processes. 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.

Compliance 52

Compliance Regulation Clinical Research Clinical Trials 52

XTalks

JANUARY 19, 2022

The way in which clinical trials are conducted is entering a new dimension as clinical trial operations are becoming more adaptable. The COVID-19 pandemic certainly has pushed to the forefront of clinical trials, the digital evolution in clinical research. MRI scan, endoscopy, etc.)

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Clinical Trials Clinical Trials Trials Clinical Research 98

Drug Discovery World

MARCH 21, 2023

New EU legislation designed to improve public health is delaying clinical trials and blocking access to new treatments for cancer and rare diseases, says the European Federation of Pharmaceutical Industries and Associations (EFPIA). The In Vitro Diagnostic Regulation (IVDR) came into effect in May 2022.

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