We have extensive hands-on experience managing the clinical study process.

The following activities are driven by regulatory and marketing strategy requirements:

Clinical study design
Protocol and Case Report Form (CRF) development
Informed Consent preparation
Custom database development
IDE Preparation and Submission
IRB and Ethics Committee submissions
Site evaluation / qualification
Trial initiation and monitoring
Accelerated enrollment
Study management and coordination
Electronic Data Capture (EDC) Systems
Data analysis
Interim and final study reporting
Study close-out
IDE approval