Medical Device - Clinical Operations
ICON is uniquely able to support you through all phases of clinical trial development and testing
We have a dedicated medical device team, including project managers, data managers, clinical monitors, biostatisticians, and regulatory and QA experts. 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 post-market 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:
- Imaging and Adjudication Services
- Central Laboratory Services
- Strategic Resourcing
- Commercialisation and Outcomes (pricing and market access, reimbursement, health economics, patient reported outcomes)
- FDA BIMO Audits
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.
