Pillars of Service

Specific Services Offered:

  • Training physician and medical staff on proper prep, set-up and use of novel medical devices
  • Conducting in-depth hands-on training and proctoring innovative procedures
  • Creation of study teams for the execution of clinical trial operations
  • Performing project management activities including management of study start-up timelines, budgets and tracking regulatory submissions and approvals
  • Managing support staff, contract personnel (CRAs) and core-lab personnel
  • Creating and negotiating study and site budgets
  • Conducting all aspects of clinical trial operations including: pre-qualification visits, site initiation visits, and interim/close-out monitoring visits
  • Conducting data management function and data review
  • Creating study protocol, informed consent template and CRFs including writing database completion guidelines
  • Assisting with identification of project goals and determination of study objectives and clinical endpoints
  • Implementing Quality System Program including creating and writing standard operating processes and procedures
  • Assisting with study recruitment and developing strategies to achieve enrollment milestones
  • Facilitating safety committee meetings including preparation of adverse event packets and documentation
  • Ensuring and documenting on-going and productive communication between study site and sponsor personnel
  • Assisting with site or sponsor inspections from regulatory agencies including the FDA
  • Facilitating/conducting investigator meetings and advisory board meetings