PMBoK, ISO 9001, and ICH GCP: Three Pillars of Quality in Clinical Research The quality of clinical research is fundamentally supported by strict adherence to international standards and guidelines. In this context, the Project Management Body of Knowledge (PMBoK), ISO 9001, and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) standards play a crucial role. These standards are interconnected Read more
Clinical Research Focus. 30th Edition Key Takeaways From The 2024 ASCO Annual Meeting The 2024 ASCO Annual Meeting has once again proven to be a cornerstone event in medical science, showcasing groundbreaking research and clinical advancements that are set to transform cancer treatment and patient care. While it is impossible to cover all the significant research presented at this esteemed Read more
Major Enhancements Set to Transform Clinical Trial Practices with ICH GCP E6 R3 As the anticipated adoption of ICH GCP E6 (R3) in October 2024 approaches, it’s essential to understand the transformative impact these changes will bring to clinical trials. The shift from the previous R2 to the enhanced R3 version introduces greater flexibility and increased rigor in clinical research, catering to contemporary needs and challenges. Key Messages: Read more
Digital Twins in Clinical Research: Revolutionizing Study Design The concept of digital twins, a staple in industries like manufacturing and aerospace, is now making its way into the realm of clinical research. This technology involves creating a virtual replica of a physical entity—in this case, a patient or a biological process—which can then be used to simulate and predict outcomes without direct experimentation. Read more
