Maintaining safety within clinical trials is important for any pharmaceutical company wishing to market new products. It is also important to harmonise the way to gather and, if necessary, to take action on important clinical safety information arising during clinical development.
It must be recognised that a medicinal product will be under various stages of development and/or marketing in different countries, and safety data from marketing experience will ordinarily be of interest to regulators in countries where the medicinal product is still under investigational-only (Phase 1, 2, or 3) status. For this reason, it is both practical and well-advised to regard pre-marketing and post-marketing clinical safety reporting concepts and practices as interdependent, while recognising that responsibility for clinical safety within regulatory bodies and companies may reside with different departments, depending on the status of the product (investigational vs. marketed).
Our Clinical Trial Safety Services recognizes the need to demonstrate your commitment to patient safety to regulators, your stakeholders and the general public on an ongoing basis. We look forward to helping you achieve your Clinical safety needs.
CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING ICH Harmonised Tripartite Guideline