Worldwide Clinical Trials

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations.

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Advarra

MARCH 6, 2025

Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinical research. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinical trials, which judiciously test and evaluate safety and efficacy.

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Pharmaceutical Technology

OCTOBER 25, 2022

Furthermore, data regulations around the world add another burden of compliance and need careful management. One solution that increasing numbers of pharmaceutical companies, healthcare providers, and clinical research organisations are turning to is Cassie by Syrenis, which is a Consent Management Platform (CMP).

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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. Do you lose revenue in research? Are you calculating fair market value correctly?

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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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Cloudbyz

AUGUST 30, 2024

The introduction of Clinical Trial Management Systems (CTMS) has revolutionized how trials are conducted by streamlining operations, enhancing regulatory compliance, and reducing the risk of errors. Managing these trials efficiently while ensuring compliance with stringent regulatory standards is paramount to their success.

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Advarra

AUGUST 8, 2024

The EU AI Act’s implications extend into clinical research, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms. Non-EU companies must comply with the AI Act if their AI systems are used in the EU market.

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Clinical Trial Podcast

FEBRUARY 23, 2021

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”.

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ACRP blog

MAY 6, 2024

Also sharing advice on breaking free of unproductive habits on Saturday was Suzanne Kincaid, CCRA, ACRP-PM, FACRP, Consultant and Owner of Responsibility Research, in her session on “The Intersection of Technology and People: Harnessing Technology to Increase Efficiency and Build Relationships.” On Day Two of ACRP 2024 in Anaheim, Calif.,

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VirTrial

AUGUST 21, 2021

Finally, any mention of HIPAA is usually in the context of “compliance” through a Business Associate Agreement (BAA), and supporting documentation is usually rife with ambiguities. Other important characteristics that make these solutions ideal for clinical research include: HIPAA, HITRUST, and/or SOC 2 certification (not just “compliance”).

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ACRP blog

FEBRUARY 2, 2023

Many clinical research professionals “fell into” this career pathway rather than choosing it deliberately from the outset. Multiple career trajectories can bring individuals into clinical research,” said Kristen Gurnea, MPH, CCRC, ACRP-PM, Manager of Clinical Research at Renown Health.

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ACRP blog

SEPTEMBER 12, 2024

ACRP reached out to experts from graduate programs in clinical research for a snapshot of how education in this field, especially at the master’s degree level, is holding up amidst rapidly evolving changes in the research enterprise itself. Some are recent undergraduates and others mid-career professionals or clinicians.

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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. Real-time Quality Assurance: Quality control and assurance are crucial aspects of clinical trial management.

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Worldwide Clinical Trials

JULY 9, 2024

Challenges in GLP-1 Medication Usage Despite the emerging therapeutic benefits of GLP-1 medications, these treatments also face several challenges, including: Patient Compliance Due to Side Effects One considerable challenge of GLP-1 treatments is their administration method, which is typically a daily injection.

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ACRP blog

OCTOBER 19, 2023

This fear of non-compliance can significantly affect a site’s bottom line. Allocating resources: Clinical research is resource-intensive in that it requires funding for staff salaries, equipment, supplies, participant recruitment, and administrative overhead.

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ACRP blog

OCTOBER 19, 2022

In the turbulent waters of the clinical research workforce, with high turnover and burnout circling like relentless sharks, several leading organizations have found ways to navigate their way through and around the worst of the storm. “It The post How to Weather the Clinical Research Talent Recruitment Storm appeared first on ACRP.

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pharmaphorum

NOVEMBER 15, 2022

A renaissance in vaccines research is just one example of something good to come out of the pandemic. For the clinical trials industry, the pandemic forced new ways of working and fresh ways of thinking about clinical research and how to conduct it remotely.

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Advarra

DECEMBER 17, 2024

2024 has been a year of growth and evolution in clinical research. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinical research, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.

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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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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

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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Advarra

NOVEMBER 14, 2024

Strengthened regulatory compliance: Different countries have varying regulatory requirements and expectations. This compliance is crucial for the successful regulatory approval and dissemination of trial results. A globally diverse DMC ensures the trial adheres to local regulations while maintaining high ethical standards.

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ACRP blog

JANUARY 17, 2025

The adoption of the ICH E6(R3) Guideline for Good Clinical Practice marks a defining moment in the evolution of clinical trial execution. As someone committed to advancing quality and innovation in clinical research, I see this milestone as an opportunity for our field to grow and adapt in meaningful ways.

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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. A missing data check ensures this field is not left blank.

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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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Clinical Trial Podcast

JULY 31, 2022

He is currently the Principal Attorney of Kulkarni Law Firm where he focuses his practice on providing healthcare companies with legal, compliance, and regulatory advice. He has led rare disease pharmaceutical companies in developing global programs to foster clinical trial transparency and enhance public health.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 8, 2023

Computational chemistry is today very much required for pharmaceutical compliance including prediction of toxic behaviour of nitrosamine for drug safety, according to experts. Identification and determination of toxic behaviour of a molecule is one of the most difficult challenges faced in ensuring drug safety.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 4, 2023

Indian pharma & healthcare faces numerous challenges in the supply chain, such as lack of visibility to the recipients and the shippers, maintaining the integrity and safety of temperature-sensitive products, meeting regulatory compliance requirements, and managing logistics costs while ensuring timely delivery.

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ACRP blog

FEBRUARY 19, 2025

A healthy relationship between sites and sponsors is critical to the success of clinical trials, including efficient and effective management, adaptability, innovation, problem-solving, and feedback mechanisms on the parts of those involved on both sides. Finally, we should provide training and resources to help sites maintain compliance.

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ACRP blog

AUGUST 7, 2024

Within the clinical research enterprise, as can be seen elsewhere in business and regulatory landscapes, the terms “quality” and “compliance” often intersect, creating what some feel is a symbiotic relationship crucial for organizational success.

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ACRP blog

JANUARY 8, 2024

Few industries have a need to understand the complexities of compliance more than clinical research. The importance of compliance in clinical research cannot be stressed enough. This year’s Compliance Institute features more than 100 educational sessions across 14 unique learning tracks.

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ACRP blog

FEBRUARY 4, 2025

Our team approach is central to success, involving expertise across clinical research disciplines. As a bridge between the sponsor/contract research organization (CRO) and sites, our use of proven quality improvement practices consistently reduces start-up timelines while maintaining quality and compliance.

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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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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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pharmaphorum

DECEMBER 22, 2022

For instance, at a recent presentation to the Society of Quality Assurance 2022 Annual Meeting , the FDA Office of Regulatory Affairs Bioresearch Monitoring Division Director Anne Johnson emphasised that DCTs are largely reliant on electronic data integrity and therefore subject to firmly established 21 CFR Part 11 compliance.

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ACRP blog

FEBRUARY 28, 2024

Department of Justice (DOJ) officials have made it clear in the last few years that investigation and enforcement of clinical research misconduct is an increasing priority. Mingqing Xiao ) Clearly, there are a multitude of regulations that impact clinical research, and it’s vital to stay up to date on the latest industry developments.

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Drug Patent Watch

DECEMBER 11, 2024

It is crucial to determine whether you will be working with a CDMO for discovery and drug development all the way through approvals and commercialization or if your work with a CDMO will begin with preclinical development or clinical research. Range of Services The range of services offered by a CDMO is another vital criterion.

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