Study Initiation & Start-Up

Study initiation is one of the most demanding and time-critical components of trial management.  This is evident for our sponsor’s project team as well as ours. There are a number of key tasks that must be coordinated and performed simultaneously to ensure FPFV is attained on time. BioClinica has a dedicated Start-Up Team that assists the Project Manager to conduct and implement the tasks and functions for a smooth and effective study initiation. The Start-Up Team is another component of our quality process.

These tasks include, but are not limited to the following:

  • Identify expert readers and consultants
  • Assign project team
  • Engage Study Start-up Team
  • Design imaging protocol
  • Communication plans
  • Project specific work instructions
  • Develop Imaging Review Charter
  • Deploy site surveys
  • Attend investigator meetings
  • Provide imaging study kits
  • Perform site visits
  • Conduct web-based training