by Kimberly | May 30, 2024 | Subscriber Articles
FDA inspections, while critical for ensuring the safety and efficacy of clinical research, can be a significant source of stress for clinical site staff. The anticipation and the process itself can create anxiety, but with the right strategies, your team can navigate...
by Kimberly | Apr 30, 2024 | Subscriber Articles
FDA inspections are a critical aspect of clinical research, ensuring adherence to GCP standards and safeguarding participant well-being. Our comprehensive guide is designed to empower your clinical site to navigate these inspections successfully, transforming...
by Kimberly | May 31, 2023 | Subscriber Articles
A quality culture pertains to the shared beliefs, values, and attitudes that incorporates a quality mindset which also influences the actions taken by individuals within an organization. It is essential to establish a quality culture in the workplace in clinical...
by Kimberly | Mar 23, 2022 | Subscriber Articles
ICH E6 (R3) Guidelines for Good Clinical Practices (GCP) have been a work in progress to put forward changes to the previous R2 version. The overall purpose is to revise principles that account for ethical trial conduct, participant safety, and clinical trial...
