PROJECT MANAGEMENT

COMMUNICATION

With every study, we assign a qualified Project Manager with a broad background in clinical research development and whose skills best match the trial requirements. We understand that communication between the Project Manager and the client is the major factor for achieving a successful project.

Improved and continuous communication and increased accountability ensures that the project stays on track, on time and within budget. Our structure improves accountability of deliverables and allows for improved peer to peer communication - between the sponsor's and Amarex's PMs - ensuring more effective communication and successfully providing deliverables across the entire project team.

Our PMs are required to have the appropriate training and experience in clinical research.

Our PMs also receive additional training:

  1.  Project Plan Creation

  2. Project Management Systems

  3. GCP and HIPAA Guidelines and Requirements

Services include:

  • Development of a Project Plan

  • Creation of Study Operation Manual

  • Maintenance of Trial Master File

  • Initiation of  Pre-Clinical and Clinical Trial Setup

  • Coordination of Site Selection, Contracting and Management

  • Management of Institutional Review Board Submission Process and Approvals

  • Coordination of Study Vendors

  • Management of Site Payments

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