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Study Management and Conduct

Study Management and Conduct

Fundamental to the success in the conduct of clinical studies is a strong project team.  And this is what the staff at Plunkett Consulting Group provide.  From the Project Manager to the Clinical Research Associates (CRAs), our team is a collection of highly experience members whose primary ambition is to facilitate the conduct of a successful study that leads to safe and effective treatments for Australian patients.  Our project teams are built around our client’s needs, led by a Project Manager who becomes the primary point of contact  between our team and our client. Our policy is to remain transparent at all times on study status, issues encountered and successes achieved.

Plunkett Consulting Group’s full service activities may include:

  • Site identification and feasibility
  • Ethics Committee approvals and regulatory notification
  • Patient recruitment strategy development and implementation
  • Project management and monitoring for Phase I – IV studies
  • Site management activities
  • Essential document review, collection and processing
  • Ensuring compliance with study protocol and GCP requirements
  • Site training and staff education
  • Third party vendor management
  • Review of investigational product accountability and storage
  • Resolution of data queries
  • Study mail outs and newsletters
  • Database lock and study close out of sites

As a fully integrated service, this ensures your contact with Plunkett Consulting Group staff remains of the highest quality from start to finish.

Service:  

Clinical Development