Clinical Research studies the effectiveness and safety of medications, medical devices and in-vitro diagnostics intended for human subjects. As such, it advances knowledge on the design and conduct of clinical trials and studies-related research methodologies.
The term "clinical research" refers to a drug/device/biologic biography, from any test article or prototype product to its inception in the lab to its introduction to the market and beyond.
The clinical research ecosystem involves a complex network of sites, pharmaceutical companies, medical device and in-vitro diagnostic manufacturers and academic research institutions. This has led to a growing field of technologies for managing clinical research data and operational factors.
Quality Control is the cornerstone of clinical research, ensuring the protection of human subjects and data integrity. Every step of a clinical study or trial, from the statistical calculation to the drafting of the final study report, must be embedded in a robust quality system, which ensures adherence to regulations and adequacy and consistency with company policies.
Courses within this category address Clinical Research on humans and Quality Assurance and guide participants on the design, conduct, analysis, synthesis and evaluation of critical methodologies.
These are interactive workshops, seminars, and discussions) and may be of interest to those who work in the life cycle of a pharma product or of a medical device or in-vitro diagnostic.
Training sessions remain on the cutting edge of the latest topics, including ethics, regulation, and policy impact.