Project Management

As a full-service CRO, the GCP-Service Project Manager team is aware of the importance of being able to service a wide range of clinical phases and types of clinical studies. While Phase I studies provide important initial information for planning strategies within a drug development program, post-marketing studies are important in that they deliver real-life data on study populations which were often excluded from the clinical studies.

Regardless of whether you want to investigate a pharmaceutical product, a medical device or combination product, your clinical study and your project are in good hands at GCP-Service. This multinational expertise, derived from experience in a multitude of clinical studies, is an asset for clients needing support during the development process of their medical product.

GCP-Service offers two kinds of Project Management:

  • Lead CRA
  • Project Manager

Lead CRA

The Lead CRA is the primary sponsor contact during the Clinical Monitoring phase from site selection to site closure. The Lead CRA has similar responsibilities to the Project Manager, however is also responsible for study sites. This has the advantage that the Lead CRA is always aware of the ongoing site procedures. Responsibilities of a Lead CRA are:

  • Formulate plans for site initiation, site management, CRF retrieval, closeout
  • Define and communicate performance expectations
  • Assign sites on behalf of the sponsor
  • Develop project specific tools
  • Review and approve monitoring reports
  • Ensure quality and consistency
  • Team leadership and project-specific Training
  • Communicate with sponsor, Project Manager and internal departments

Project Manager

The Project Manager of GCP-Service is the sponsor contact for the whole project. He drives the clinical trial projects from beginning to end. The Project Manager is responsible for a detailed quality risk analysis, project start-up meetings, frequent client meetings and discussions, and internal project team meetings. The Project Management of GCP-service ensures all involved parties are fully informed of - and are adhering to - study requirements and therefore oversee timelines, scheduling, task assignments and financial tracking.

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Locations where GCP-Service managed clinical studies during the past 6 years