ACRP blog

JANUARY 6, 2025

Clearly, the role of compliance in clinical research is a critical area of focus, and one with the potential for significant consequences if overlooked or minimized. But how do you add compliance education to your already full plate? A Compliance Perspective Ashaben Sharma, Research Compliance Quality Auditor II, H.

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World of DTC Marketing

JUNE 6, 2025

Bringing this ethos into the corporate setting can enrich company culture and help bridge internal silos between marketing, R&D, and compliance. Stakeholder Communication Messaging in the public sector is often formal, cautious, and compliance-driven. Where the Gaps Often Lie 1.

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Pharma Marketing Network

MAY 23, 2025

From natural language generation to intelligent analytics and modular content systems, AI tools are giving brand teams a competitive edgewithout compromising trust or compliance. For pharma, the challenge lies in deploying AI within strict compliance frameworkswithout sacrificing creativity.

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ACRP blog

JANUARY 28, 2025

However, if the personal data relates to European Union (EU) or United Kingdom (UK) residents, this raises particular legal and compliance issues due to the General Data Protection Regulation (GDPR). Edited by Jill Dawson The post Research, Innovation, and Compliance in the EU and UK: A Data Privacy Roadmap appeared first on ACRP.

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Drug Patent Watch

MARCH 26, 2025

In our latest blog post, we delve into the compliance hurdles that generic drug developers face, and the valuable lessons learned from these experiences. This not only helps to ensure compliance, but also fosters a culture of trust and cooperation within the industry. Share your experiences with us in the comments below!

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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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Imperical Blog

MAY 14, 2025

1 Through diversity action plans,… The post Clinical Trial Diversity Action Plans: 6 Key Components for Compliance appeared first on Imperial Clinical Research Services Blog.

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Rethinking Clinical Trials

DECEMBER 18, 2024

The fidelity to the NCM intervention, measured by the participation in 20 NCM calls and the compliance with HBPTM, was around 68% – a decent figure given the challenges of conducting a trial in a real-world setting, Dr. Ogedegbe noted.

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Scienmag

JUNE 6, 2025

and their colleagues, recently published in the Journal of Perinatology , illuminates the complex interplay of maternal, neonatal, and hospital-related factors that dictate compliance rates with DCC protocols in infants born before 33 weeks of gestation. One of the notable findings revolves around maternal factors influencing DCC compliance.

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XTalks

MAY 12, 2025

Moreover, they discuss strategies to maintain compliance amid evolving regulatory challenges. Currently, many trials depend on a patchwork of digital tools for data collection, safety monitoring and compliance reporting. Mr. Villarreal emphasizes the importance of choosing technology platforms rooted in compliance.

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XTalks

NOVEMBER 6, 2024

XTALKS WEBINAR: Unlock Growth in Medical Device Manufacturing with an AI-Powered eQMS Live and On-Demand: Monday, December 9, 2024 , at 11am EST ( 4pm GMT / UK) Register for this free webinar to discover how AI integration can transform compliance, streamline operations and position medical device manufacturers for unprecedented growth.

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Rethinking Clinical Trials

NOVEMBER 21, 2024

However, these trials can pose risks related to: verifying participant identity delivering the investigational product to the participant minimizing lags between participants’ data entry and identification of the need for action to ensure safety and compliance, including adherence to treatment and outcome measurements “With these risks to integrity (..)

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World of DTC Marketing

JUNE 3, 2025

After all, Medical Affairs serves as the bridge between clinical research, regulatory compliance, marketing, and real-world evidence — all areas where deep medical knowledge is a valuable asset. In the pharma industry, it’s almost reflexive to tap an MD for the role of Vice President of Medical Affairs.

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ACRP blog

JUNE 13, 2025

With strict regulatory bodies, an ‘at no risk’ approach, and worries about safety, compliance, and being sued, the fears surrounding AI are clear,” he adds. Those who fail to enter the discussion will be left behind.” The slow pace of adaptation of AI in clinical research is understandable, he notes.

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World of DTC Marketing

JUNE 8, 2025

Loss of the Strategic Marketer As pharmaceutical companies became more compliance-driven, a cultural shift occurred. The strategic marketer—once an influential visionary—has gradually given way to a compliance-first mentality. Creative marketers found themselves overshadowed by regulatory and legal teams.

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Scienmag

JUNE 17, 2025

This reprogramming drives abnormal vascular remodeling, characterized by increased muscularization and reduced compliance, hallmark features of PPHN. These changes are not random but rather highly coordinated, suggesting a complex regulatory network that shifts pulmonary vascular cell behavior towards a pathological phenotype.

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Scienmag

JUNE 30, 2025

This fast, painless procedure stands in stark contrast to the discomfort and duration of mammograms or MRI sessions, potentially improving patient compliance and screening rates.

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Scienmag

JUNE 19, 2025

These adaptations could significantly improve patient compliance and clinical outcomes. Moreover, the platform’s ultrahigh colloidal stability could enable more flexible dosing schedules, patient-friendly administration routes, and the development of novel formulations such as injectable gels or inhalable aerosols.

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Scienmag

JUNE 23, 2025

Standard procedures only yield usable maps around two-thirds of the time, primarily due to issues associated with patient compliance and motion artifacts. As the software enters the marketplace, its advantages over traditional methods of task-based fMRI are significant.

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Scienmag

JULY 1, 2025

Traditional methods to assess fatigue typically rely on self-reporting questionnaires or physiological monitoring, both of which present significant limitations due to subjectivity, compliance challenges, or intrusiveness.

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Scienmag

JUNE 30, 2025

These validations, in turn, inform regulatory submissions and compliance with governing bodies such as the FDA or EMA. By identifying bottlenecks in scalability, reproducibility, and regulatory compliance, the work provides a valuable blueprint for stakeholders invested in sustainable biomaterial development.

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World of DTC Marketing

JUNE 26, 2025

Ethics and Compliance as Core, Not Cover Medical Affairs is uniquely positioned to build credibility—or lose it. What to look for: Examples of delivering major milestones under pressure—e.g., supporting an NDA/MAA filing, a global launch, or managing a product during a safety signal investigation. The best VPs don’t cut corners.

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XTalks

MAY 13, 2025

Clean Labels, Bold Colors: Industry Trends Driving Natural Pigments Manufacturers are steadily expanding their use of plant-derived pigments such as turmeric and beet extracts to meet growing interest in clean-label ingredients.

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XTalks

JANUARY 8, 2025

In manufacturing, an AI-based system assessing drug vial fill levels must be complemented by independent quality control measures to ensure compliance. Non-compliance can arise if training data is not representative or if development lacks transparency.

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World of DTC Marketing

JULY 14, 2025

Compliance Constraints Regulatory compliance (both internal and external) continues to limit how pharma communicates with physicians. Skepticism Toward Pharma Motives There’s a lingering distrust among some physicians, rooted in past promotional excesses or concerns about biased clinical data.

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Scienmag

JULY 2, 2025

Such innovations could revolutionize psychiatric treatment paradigms for schizophrenia, offering safer modalities that enhance patient compliance and improve overall outcomes.

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XTalks

OCTOBER 31, 2024

XTALKS WEBINAR: Unlock Growth in Medical Device Manufacturing with AI-Integrated eQMS Live and On-Demand: Monday, December 9, 2024 , at 11am EST (4pm GMT / UK) Register for this free webinar to discover how AI integration can transform compliance, streamline operations and position medical device manufacturers for unprecedented growth.

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XTalks

JANUARY 30, 2025

Benefits of Oral Liquid Dosage Forms Paediatric dosage forms (PDFs) provide considerable advantages over traditional oral solid dose (OSD) products, particularly in terms of improving patient compliance and ensuring therapeutic effectiveness. One of the most significant benefits of PDFs is their ease of administration.

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ACRP blog

APRIL 26, 2025

Missing his first ACRP conference in about 14 years, but supplementing the panelists thoughts via a recorded message, David Burrow, Director of the Office of Scientific Investigations in the Office of Compliance for the U.S. Talking about Demystifying Institutional Review Board [IRB] Structures and Processes , Mooso said U.S.

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Drug Patent Watch

DECEMBER 30, 2024

Manufacturing and Quality Control : The PMDA evaluates the manufacturing process and quality control measures of the generic drug to ensure compliance with Japanese regulatory standards.

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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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World of DTC Marketing

JULY 16, 2025

If Medical Affairs wants to be seen as a strategic pillar, not just a compliance necessity, its senior leaders must understand and participate in the commercial realities of launching a drug. The Future is Integrated, Not Isolated The future of pharma is not one where departments operate in silos. Don’t silo your talent.

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ACRP blog

OCTOBER 22, 2024

Ensure Quality and Compliance: Adopt a quality management system and identify best practices to ensure regulatory requirements are met and quality metrics are evaluated.

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FDA Law

FEBRUARY 18, 2025

The answers below are based on my experience as a reviewer and compliance officer at FDA during the 5-week 2018/2019 government shutdown. Most of FDAs reviewers are exempt, while compliance, policy, and administrative support are typically furloughed. What does it mean for FDA staff?

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XTalks

MAY 13, 2025

From arranging advisory boards to delivering compliance training via the Scout Academy, the companys Clinical arm handles all travel and payment logistics for patients and sites, aiming to reduce participation-related burdens.

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XTalks

NOVEMBER 15, 2024

MDS are a group of blood disorders caused by abnormal development of blood cells in the bone marrow. These disorders result in a shortage of healthy blood cells, leading to symptoms such as fatigue, weakness, infections and easy bruising or bleeding.

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