Imperical Blog

APRIL 11, 2023

This final installment explores clinical trial retention and compliance. Are you waiting too long to begin planning patient retention and… The post Hidden Causes of Clinical Trial Retention and Compliance Issues appeared first on Imperial Clinical Research Services Blog. Part one is here, and part two is here.

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Imperical Blog

APRIL 11, 2023

This final installment explores clinical trial retention and compliance. Are you waiting too long to begin planning patient retention and… The post Hidden Causes of Clinical Trial Retention and Compliance Issues appeared first on Imperial Clinical Research Services Blog. 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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WCG Clinical

SEPTEMBER 7, 2023

This investment supports efficient site activation; it also maintains compliance as new site staff are brought on board and allows existing staff the opportunity to refer to the training should questions arise. Supports compliance by ensuring documentation is consistently available.

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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. Montalvo Villa, et al. )

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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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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.

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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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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 91

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. GDPR, HIPAA) Adequate backup and disaster recovery procedures d.

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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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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 86

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 92

Advarra

DECEMBER 14, 2023

Sponsor study team members and research sites each play a critical role in clinical trial executions. Both inspection findings and inspection failures could reduce the quality of the trial data, with inspection failures being most disruptive. In addition, many research trials are conducted over the course of many years.

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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 81

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

Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

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Compliance Clinical Development Development Clinical Trials 52

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

XTalks

JANUARY 15, 2024

From the continuing trend of the rapid adoption of AI tools to the growing use of real-world evidence (RWE) in regulatory decision-making and a focus on enhancing data integrity, find out how clinical trials will evolve in 2024 to shape the future of medical research. percent from 2023 to 2033.

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Clinical Trials Clinical Trials Trials Clinical Research 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. 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 85

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 72

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

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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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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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 70

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

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 89

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. However, further improvements are needed , including: Refinement of trial designs that address specific factors (e.g.,

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Clinical Trials Clinical Trials Compliance Trials 130

Drug Discovery World

MAY 8, 2024

Fiona Maini , Senior Director Global Compliance & Strategy, at Medidata looks at the rise of artificial intelligence (AI) and machine learning (ML) within life sciences and the applications for the technology in clinical trials.

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Clinical Trials Clinical Trials Trials Regulation 64

Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. The first trial was decided in April 2020 (discussed here ).

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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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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

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 79

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. Historically, the management of budgets and payments in clinical trials has been a paper-based process.

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Clinical Trials Clinical Trials Trials Compliance 86

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. Computer systems used for clinical trials fall under Food and Drug Administration (FDA) 21 CFR Part 11.

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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 order to keep up with this fast-paced environment, sponsors and Contract Research Organizations (CROs) are now racing to implement unified clinical trial management platforms.

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Clinical Trials Clinical Trials Trials Compliance 78

Drug Discovery World

MAY 17, 2024

Deepika Khedekar , Associate Centralized Clinical Trial Lead at IQVIA Inc, looks at the challenges of utilising artificial intelligence (AI) in oncology clinical research. MIT research 4 tells us a hard truth: about 95% of these trials fall short, leaving behind a trail of broken hopes for cancer patients each year.

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