Our international Project Management team at GCP-Service offers expert coordination of your study by offering oversight and transparency throughout the duration of the study.
The Project Management of GCP-Service ensures all involved parties are fully informed of and adhering study requirements by overseeing timelines, task assignments, and maintaining budgets.
Services GCP-Service Projects Managers offer:
- Serve as the sponsor’s main contact
- Liaison between sponsor, project teams, and vendors
- Organization of project plans (e.g. Communication Plan, Project Management Plan, Quality Risk Management Plan, Statistical Analysis Plan, etc.)
- Organization of set-up of electronic tools (CTMS, eTMF, eISF, EDC, IRT, ePRO, Safety Database, etc.)
- Team communication and coordination meet to study timelines
- Development of project specific processes
- Coordination and team members training on study specific tasks, protocol, SOPs, plans
- Study budget control and investigator fee invoice management
The increasing complexity of clinical studies and conduct of international trials requires a set of vendors like central lab, IMP deport, central evaluation center, translation agency and supplies (centrifuges, fridges, sterile labels, pregnancy tests), which is handled by the Project Manager.
- Identification of adequate vendor
- Sub-contracting, budget negotiation of vendors and budget control
- Process development and documentation to incorporate vendors into study conduct and team awareness
- Coordination of supply management
- Vendor oversight and training
Quality Risk Management
Development of a set of key risk factors within the team including sponsor, to ensure to remain the focus throughout the study on arising risks and risky study sites.
- Development of key risk factor regarding patient safety, patient rights, data integrity, data quality
- Risk oversight throughout the study, if key risk occur
- Initiation of corrective and preventive actions upon risk occurrence,
Regular Risk Mitigation Meetings to evaluate and re-evaluate defined risks
Ensures prior to site initiation, the training, scientific and organizational exchange between investigator site and sponsor/CRO teams to boost team bonding, study commitment and identify process gaps from the investigator team, which enhance quality if subsequent site initiation visits study training.
- Preparation of agenda topics, speakers and presentations
- Organizing hotel including shuttle service to hotel and/or meeting location for participants
- Organizing meeting location including equipment and evening event (for example restaurant, sightseeing etc.)
- Management of travel reimbursement of participants