Clinical Trials

COMPREHENSIVE CLINICAL TRIAL SERVICES

Eminence Clinical Research, Inc. provides personalized services customized to the goals of medical device manufacturers. We establish partnerships with companies to ensure the development of optimal clinical-regulatory trial strategies and conduct of quality studies for all phases of research.

• Our clinical applications staff will provide custom-designed device training on-site.
• Our goal is to provide products and services of the highest quality in order to most efficiently meet your goals.
• Allow us to partner with you to provide clinical research strategy, design, and management of first-in-human trials to outcomes registries.

STRATEGY, DESIGN, AND EXECUTION THROUGHOUT THE PRODUCT LIFE-CYCLE

• First-in-Human Trials
• Feasibility and Safety Studies
• Pivotal (IDE) Studies
• Post Market Approval Studies
• Outcomes Registries
• Retrospective Studies

COMPREHENSIVE CLINICAL TRIAL PROJECT MANAGEMENT

• Protocol Design and Development
• Core Lab Qualification Visits and Reports
• Case Report Form Design and Development
• Informed Consents
• IRB Submissions
• Develop study-specific site-investigator qualification criteria
• Pre-study site-investigator qualification
• Site Initiation Visits Customized for Your Study:
  • Comprehensive Protocol Training
  • Comprehensive Device Training
  • Training to Promote Protocol Compliance
  • Good Clinical Practice Training
• Clinical Applications Staff To Proctor Your Procedures
  • Device Training Development
  • Clinical Site Proctoring
• Interim Monitoring
  • Customized monitoring plans
  • Data monitoring according to a monitoring plan
  • Efficient practices
• Site Close-out Visits
• Reports
  • Annual Reports
  • Interim Reports
  • Final Reports