Project Management

Our experienced, knowledgeable and dedicated Project Management teams have a broad range of scientific, clinical and industry backgrounds to ensure successful clinical trials. Our Project Managers oversee all project activities to ensure that all project deliverables are of the highest quality and are completed on-time, within budget, and in compliance with GCP and other regulations, with seamless integration throughout.

Project Management Services include:

  • Conduct Site Feasibility Assessments
  • Plan and Chair Kick-off Meeting(s)
  • Investigator Meeting Planning, Conducting and Presenting
  • Develop Detailed and Realistic Project Timeline with Clearly Assigned Responsibilities
  • Prepare Project Management Plan
  • Prepare Project Contact Lists
  • Project Specific Operating Procedures (SOPs) and Plans
  • Overall Set-up and Management of the Project Trial Master File (TMF)
  • Overall Management of Site Monitoring and Associated Documentation
  • Overall Management of Study from Study Initiation through Close-Out
  • Ensure compliance with Regulatory Requirements and Good Clinical Practices
  • Manage Subject Recruitment/Enrollment Timeline
  • Track and Report Study Execution Against Agreed Upon Timeline
  • Track the Status of Study Data, Milestones, Deliverables and Budgets
  • Oversight of the Scope of Work and Budget
  • Serve as a Liaison for Sponsor, Investigators and Project Team Members
  • Vendor Management and Support
  • Manage Processes Across Functional Groups
  • Provide Timely Project Status Reports
  • Review Monitoring Visit Reports and Communication
  • Communicate Trial Progress to Sponsor
  • Conduct and Provide Meeting Minutes of CRO/Sponsor Project Team Meetings
  • Prepare and Distribute Newsletters
  • Closure of Trials, including Quality Control
  • Archiving of Required Study Documentation and Distribution of TMF to Sponsor