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​