June 10, 2025
Informed consent in clinical research is often considered a regulatory checkbox, but it deserves far more attention. At its core, it’s an ongoing ethical commitment to transparency, respect, and protecting human participants. Yet too often, informed consent is reduced to paperwork. At Compliance Architects, we believe this critical process must evolve to meet the demands […]
June 10, 2025
Informed consent is not a checkbox. It’s not merely a form signed and filed. It is a living, ethical, and regulatory process rooted in the foundational values of autonomy, transparency, and respect for individuals. As clinical research grows more complex and diverse, with digital platforms, decentralized trials, and global recruitment, the principles of informed consent […]
June 4, 2025
Quality Assurance (QA) in Clinical Development has significantly changed over the past two decades. The US Code of Federal Regulations (CFR) initially did not explicitly mandate a system for managing quality throughout all stages of the clinical trial process. However, developing the FDA’s Bioresearch Monitoring (BIMO) Program and subsequent international standards has transformed the landscape […]
June 3, 2025
In May 2023, the International Council for Harmonization (ICH) released the Step 2 draft of ICH E6(R3) for public consultation. This transformative update marks a significant milestone in the evolution of Good Clinical Practice (GCP). On May 22, 2024, the ICH announced the final Step 5 version of ICH E6(R3), a transformational update to the […]
May 22, 2025
MedTech: A Growing Industry for Mergers and Acquisitions The MedTech industry creates life-changing products to improve patient care. Companies in this field often merge, buy, or sell to grow their businesses. But these deals do not always succeed. Problems can arise when companies do not plan well or fail to focus on quality. A strong […]
May 22, 2025
In today’s rapidly evolving regulatory landscape, ensuring a robust quality culture is essential for any organization in the biopharmaceutical industry. Our latest infographic below offers a clear visual guide on how Compliance Architects can help you map out your quality strategy over the next three years. See the infographic below. The Journey Begins: Check Your […]
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