Pharma Marketing Network

MARCH 6, 2025

This article explores effective social media advertising strategies tailored for pharmaceutical marketing executives , helping them navigate compliance and create impactful campaigns. Ensuring Compliance in Pharma Social Media Ads Navigating regulatory compliance in pharma social media advertising is one of the biggest challenges.

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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

MARCH 18, 2025

says David Vulcano, LCSW, MBA, CIP, RAC, FACRP , Vice President, Clinical Research Compliance and Integrity, at HCA Healthcare and author of a recent ACRP White Paper on Responsible Oversight of Artificial Intelligence for Clinical Research Professionals. in April.

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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. Given the critical nature of this data, ensuring its security and compliance with regulatory standards is paramount. Regulatory Penalties: Non-compliance with data protection regulations can lead to hefty fines and legal actions.

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Cloudbyz

AUGUST 30, 2024

Clinical trials are the backbone of medical advancements, but their complexity and the regulatory environment pose significant challenges to researchers, sponsors, and clinical trial managers. Managing these trials efficiently while ensuring compliance with stringent regulatory standards is paramount to their success.

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Advarra

MARCH 7, 2025

Clinical research is a vital driver of medical progress. Yet, many people are unaware of the essential role of institutional review boards (IRBs) in protecting clinical trial participants by ensuring compliance with human subject protection requirements. It is the foundation of medical innovation.

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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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ACRP blog

JANUARY 22, 2025

Independent investigators play a vital role in advancing translational “bench to bedside” research to improve human health. Setting up an investigator-initiated research program (IIRP) can encourage and support these investigators while fostering an institutions high-quality research and compliance.

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ACRP blog

MARCH 17, 2025

Regulatory costs: fees for institutional review board (IRB) approvals, data privacy compliance, and audits. Longer trials typically incur higher costs due to increased staffing needs, extended participant engagement, ongoing data management, and sustained regulatory compliance efforts. Learn more.

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ACRP blog

JANUARY 14, 2025

Change management is an overarching theme in innovation, with a need to mitigate and resolve barriers to change due to low institutional and personal risk tolerance, says David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, at the FDA Center for Drug Evaluation and Research (CDER).

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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. They generate a vast amount of valuable data, which needs to be securely archived for future reference and analysis.

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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. Pricing of biopharmaceutical medicines are influenced by various factors, and the cost of research and development (R&D) plays a significant role in determining drug prices, […]

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Drug Patent Watch

DECEMBER 10, 2024

The pharmaceutical industry has undergone significant changes over the past decade, with a growing trend towards outsourcing key aspects of research, development, and manufacturing to third-party vendors. The Rise of Integrated CDMOs The global biotechnology and pharmaceutical services outsourcing market size was valued at $70.48

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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. Food and Drug Administration (FDA).

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Pharma Marketing Network

FEBRUARY 19, 2025

This guide explores the best strategies for boosting engagement while ensuring compliance , helping pharma brands connect with their audiences more effectively. Why Pharma Needs Email Marketing Direct Access to HCPs : Doctors, pharmacists, and researchers check their emails frequently for industry updates and medical advancements.

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FDA Law Blog

JANUARY 10, 2023

20, 2022, FTC announced the publication of its Health Products Compliance Guidance (“new Guidance”). As an additional example, the 1998 Guidance stated that the FTC would accept epidemiologic evidence when supported by other evidence, such as research explaining the biological mechanism underlying the claimed effect.

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XTalks

MARCH 12, 2025

Following the success of Issue 3 , which focused on the critical importance of patient diversity in clinical research, Xtalks is thrilled to announce Xtalks Clinical Edge Issue 4. These prominent leaders will share their experiences, strategies and visions about whats next for clinical research.

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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. By discussing sophisticated use cases and best practices, we offer an in-depth perspective on how to implement effective edit checks for maximal data accuracy, compliance, and efficiency. Core Types of Edit Checks 1.

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XTalks

DECEMBER 9, 2024

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

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Bio Pharma Dive

DECEMBER 11, 2023

Research from Everest Group shows how life sciences leaders are investing in process mining to speed time-to-market, improve regulatory compliance and drive innovation.

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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

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. An example of limited and minimal risk systems include AI in benign gaming apps and language generators.

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Rethinking Clinical Trials

DECEMBER 18, 2024

The research team looked at the comparative effectiveness of HBPTM alone versus HBPTM plus telephone-based NCM when administered to Black and Hispanic stroke survivors with uncontrolled hypertension. The research team found that both groups experienced significant SBP reduction at both the six-month and 12-month mark.

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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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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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Advarra

MARCH 6, 2025

Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinical research. Without clinical research, these medical breakthroughs would remain out of reach for patients. Advarra draws members from leading academic institutions, government agencies, and clinical research organizations.

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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

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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Cloudbyz

NOVEMBER 22, 2024

This prestigious acknowledgment places Cloudbyz among the top-performing companies globally, known for delivering scalable and intuitive CTMS solutions that empower clinical research teams. Global Regulatory Compliance: Ensures compliance with 21 CFR Part 11 and other global regulations, reducing compliance risks.

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Drug Patent Watch

MARCH 13, 2025

From manufacturing and quality control to distribution and regulatory compliance, the stakes are high for pharmaceutical companies looking to bring these life-changing treatments to market. Ensuring the quality and integrity of biosimilars throughout the distribution process is crucial to maintaining patient trust and regulatory compliance.

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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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ACRP blog

FEBRUARY 4, 2025

In effort to reduce this average, HCA Healthcare Research Institute, a site management organization with around 40 sites and 275 open trials, has a centralized approach to reducing start-up timelines. Our team approach is central to success, involving expertise across clinical research disciplines.

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ACRP blog

OCTOBER 19, 2023

Research sites play a pivotal role in clinical trials in that they are responsible for participant recruitment, data collection, safety monitoring, regulatory management, overall trial conduct, and more. Financial management tools can help research sites secure the maximum allowable compensation for their services, thereby increasing revenue.

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Cloudbyz

DECEMBER 22, 2024

This achievement solidifies Cloudbyzs position as a trusted partner in advancing clinical research through cutting-edge, cloud-based technologies. Cloudbyzs dual recognition underscores its commitment to innovation , regulatory compliance, and enhanced trial efficiency. Enhance compliance and reduce audit risks.

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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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Advarra

JULY 26, 2022

As such, we are seeing an uptick in research examining the therapeutic effects of cannabis and its constituents. While there isn’t a significant amount of research on cannabidiol (CBD), it’s easily accessible in the U.S. This can make research challenging, but not insurmountable. Funding Research on Cannabis.

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