Safety reporting

Safety reporting

Safety reporting is the fundamental process of detecting safety issues related to investigational product in clinical trial participants and reporting to sponsor and relevant regulatory bodies. Our experienced staff works to evolve safety monitoring and safety reporting practices as regulatory needs change, allowing the evaluation and management of risk over a time period. RemediumOne is dedicated on ensuring management and reporting of adverse events which occur across all sites managed by us. Furthermore, we ensure that the implementation and the conduct of a clinical study occurs according to the required guidelines to provide subject safety and study integrity. Guidelines and policies of relevant ethics committees and regulatory authority are closely monitored to ensure conformance. In addition, our internal SOPs further ensures conformance to the guidelines stipulated by these bodies.