International Project Management
A team of international project managers ensures efficient coordination of your multinational study.
We provide complete planning, coordination and control of resources, timelines, communication, costs, and quality as well a detailed risk management plans, through the following activities:
- Professional management of communication and client relationship
- Definition and control of timelines and budgets
- Efficient management and coordination of a study team
- Contribution to the content of key trial documents such as protocol, patient information and informed consent form, case report form.
- Development and execution of appropriate project-related plans: communication plan, recruitment plan, quality control plan and risk management plan to guarantee the smoother project conduction and completion
- Management of contractual issues with investigators and hospitals
- Organization of Investigator’s Meetings
- Management of day-to-day operational aspects in relation to management of Country Study Managers/CRAs, organization of trainings and presentations, subjects’ recruitment, tracking of drug supply , data flow and collection , safety reporting, trial supply logistics , preparation of newsletters
- Revision of project plans as appropriate to meet changing needs and requirements
- Preparation of weekly/monthly study status reports to the sponsor
- Crisis management
- Maintenance of a central TMF