Phase II-IV Clinical Trials:
Clinical Trial Management and Monitoring

Project Management
Through strong team structures, close communication, and detailed tracking and measurement, the Project Management group delivers consistent high quality services to customers.

Projects vary based on size, complexity, therapeutic area and specific customer requirements. All projects conducted by RCRS, whether with a single service scope of work or a full-service global program, follow a common project management methodology that provides sponsors with a standardized and disciplined approach to project management. This methodology provides each Project Manager with a set of standards and guidelines to manage projects in the most effective manner.

Project Managers work closely with the sponsor project team from project kick-off and start-up through completion of the final study report or contract closure to meet their objectives. This team approach to Project Management ensures that the project will be completed according to specific study requirements and timelines. RCRS provides detailed timely tracking of each project to make sure that sponsors consistently know the status of their project. RCRS tracks key metrics and milestones for every project, and by agreeing on these milestones ahead of time with the sponsors, it lays a foundation for effective communication, reporting, continual improvement, and demonstration of success.

Project Managers have the background and skills necessary to effectively manage the following important project management components:

Customer relationships and communication
Developing and executing customer-specific requirements
Effective Project planning and scheduling
Project Resource Planning and allocation
Project Risk Planning and Analysis
Project Budgeting
Project Communication
Project tracking and status reporting
Proactive issue identification and resolution

The Project Manager serves as a primary resource and central point of communication for the project team and provides leadership and direction, including identifying and assembling training opportunities, to build a performing project team. RCRS assigns the right staff for each project, assembling a highly motivated, integrated team that best suits the needs of the study and the sponsor, based on factors such as therapeutic experience, prior site performance and location. Project teams typically consist of a project director (who supervises the team and oversees quality and training), a project manager (who coordinates communication and study activities, and manages timelines and budgets), a team leader within each operational area (e.g. a clinical team leader provides tracking, support, consistency of monitoring and support for the regional monitoring team), site monitors (who coordinate the trial at site), clinical trial assistant to coordinate the documentation and communication in the study and other operational team members depending upon the scope of work.