Clinical Operations and Project Management Services

Clinical services are tailored to each client’s requirements and are staffed with only highly qualified professionals. Our clinical operations team ensures sites carefully follow the investigational plan and together we provide our clients with confidence about human and animal research protection. Throughout the project, our clinical research professionals use effective interactions with investigational site staff to increase efficiency and provide accurate and reliable data from which to build your clinical program.

With this model, our dynamic teams are well equipped to take your program from Phase I through NDA. Our project managers collaborate with your internal project team from the start to ensure that we understand your individual needs and priorities. By closely aligning our project management methodology with your team’s needs, we are able to provide a tailored plan that meets your requirements and ensures timely communication and goal completion.

The Clinical Operations team offers the following services:

  • Global clinical trial project management
  • Clinical monitoring
  • Site feasibility assessments
  • Investigator meeting preparation and presentations
  • Risk mitigation
  • Study startup support / Essential document review and processing
  • Site management and communication production
  • Vendor management (laboratories, clinical trial material supplies, and packaging)
  • IVRS vendor selection and oversight
  • Clinical Trials Management System (CTMS)
  • Functional outsourcing
  • Investigator grant and research budget preparation and administration