June 17, 2025
Clinical research is undergoing a profound transformation, driven by technological innovation, globalization, evolving regulatory expectations, and a growing emphasis on data integrity and subject protection. At the center of this evolution is the need for robust oversight mechanisms, especially for clinical investigator site audits, which serve as a cornerstone of Good Clinical Practice (GCP) compliance. […]
June 16, 2025
Every FDA Warning Letter offers more than a glimpse into individual noncompliance; it reveals systemic risks that can impact the safety of clinical trial participants, the reliability of study data, and the integrity of an organization’s quality systems. Between 2024 and 2025, several Warning Letters were issued that highlight critical—and recurring—compliance failures in drug and […]
June 11, 2025
Informed consent is one of the most vital elements of ethical clinical research. It serves not only as a regulatory requirement but also as a profound moral commitment to the autonomy, dignity, and well-being of every participant. But its meaning has often been misunderstood, reduced to a formality—a signature on a document—rather than the process […]
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 […]
© 2009-2025 Compliance Architects Holdings LLC – used by permission. All copyrights, trademarks and other intellectual property are the property of Compliance Architects Holdings LLC and are used by permission.
