Medical Device

ICON understands the unique requirements of medical devices, diagnostics, and combination drug/device and biologic/device products.

Clinical Operations

With a dedicated medical device team, including  project managers, data managers, clinical monitors, biostatisticians, and regulatory and QA experts, ICON is uniquely able to support you through all phases of clinical trial development and testing. We will help you to design, implement, and manage a clinical trial for your device, diagnostic, or combination device that meets your business needs, whether to support a pre-market regulatory submission, drive product adoption, support product reimbursement, or monitor postmarket product use. Services include:

  • Strategy / Study Design, including Adaptive Design Trials
  • Project Management
  • Data Management
  • Biostatistics
  • Clinical Monitoring
  • Clinical Report Preparation
  • Medical Monitoring

ICON offers a full range of support services for medical device trials, including:

Rescue Services
When a medical device clinical trial is not proceeding as planned, our experts can step in quickly to resolve the situation. With a depth of experience, resources, and expertise we will assess the situation, identify roadblocks, and implement a customized plan to restore your study, ensuring that you maintain clinical site compliance and data integrity.