Project Management - GCP-Service

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.

Study Oversight

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

Vendor 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

Investigator Meetings

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

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.

Study Oversight

Vendor Management

Quality Risk Management

Investigator Meetings

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.