Clinical Operation

Our Clinical Operation Team provides full support to late phase clinical trials and outcomes research and includes the following roles:

  • Clinical Operation Manager​
  • Project Manager
  • ​Quality Control and Assurance Manager
  • Training Manager
  • Medical Science Manager
  • Clinical Program Scientist
  • Clinical Trial Manager
  • Clinical Research Associate
  • Study Coordinator
  • Project Management Coordinator
  • Clinical Research Coordinator

Clinical Operation Functions

Study Planning and Design

  • ​Study concept and process design
  • ​Study protocol development
  • Principal investigator engagement
  • Advisory Board formation and management
  • Publication planning and management

Study Implementation and Initiation

  • Site selection and recruitment
  • ​IRB/EC submission and approval
  • Clinical service agreement
  • Advisory Board and Investigator Meeting
  • Site training and patient engagement

Study Execution and Management

  • On site study initiation
  • ​Interim on-site monitoring and management
  • ​Interim remote monitoring and management
  • Patient enrollment and tracking
  • Source document verification
  • ​Quality assurance and audit
  • ​Site close-out management
  • Budget management
  • Project management

Study Planning and Design

  • Prepare for regulatory submission
  • Regulatory authority meeting and negotiation
  • AE/SAE monitoring and reporting
  • Web-based study reporting tool
  • Executive study summary
  • ​Clinical study report
  • Abstract/Poster/Slide Presentation
  • Manuscript development and submission

Interested? Call us at +1 610 727 4550