This session will provide the participant with several real-world examples of the benefits and risks of conducting early-phased medical device clinical trials, and the strategies involved in optimizing this avenue for regulatory submissions.
This session will provide an overview on how to appropriately identify, document and address compliance issues noted at sites, from monitoring and Sponsor perspectives. The objective of this session will be to review site compliance from a CRO perspective, while also discussing practical and effective corrective actions from both the monitor’s and Sponsor’s view.
The key to a successful inspection is preparing at the start of the study. The session will also include common GCP violations that are evident in the TMF/ISF and can result in findings
Providing clear and effective project management can make a successful clinical trial. Project planning and management are a part of achieving quality clinical data. This session will provide new and current Project Managers with useful tools to streamline their workload and hopefully decrease some of the common stress of the role.
Learn to describe internationally accepted principles and practices for the conduct of clinical trials and overall development strategy, facilitate the evaluation and acceptance of international trial data, and present an overview of ICH E8 other ICH guidelines pertinent to clinical trials.