Clinical Trial Management Analysis and Integration of New Policies and Procedures Into a Research Department

The purpose of this practicum was to increase productivity and efficiency in the clinical research department. Using the guidelines set out by the FDA and ICH, the team set out to maintain compliance. The addition of an organizational system will assist the staff in the endeavor of clinical research. Over the course of this internship experience, the research department added new processes, forms, and databases, increased productivity and patient interaction, and decreased the amount of time doing tasks. The main goal of the practicum project was to implement a set of tools to increase organization in the research department. As these tools were developed, they were implemented. After the collection and analysis of the data, it was determined that overall there was a slight increase in the productivity and efficiency with the research personnel. With all of the information working together, it decreased the number of tasks, and the time it took to complete some tasks.