MEDICAL DEVICES CONSULTING
Our professionals apply their therapeutic, regulatory, and operational expertise to consistently make sure that your clinical studies are conducted with ICH guidelines and other applicable regulatory requirements.
In an increasingly challenging environment, we have the experience and knowledge to find, recruit, and retain patients in clinical trials. We successfully deliver access to appropriate sites and patients, developing strategies that will minimize the risks inherent in patient recruitment.
Our clinical service for national and/or international multi-site trials includes:
- Protocol development
- Site and investigator identification and qualification
- Site initiation and training
- Clinical monitoring
- Medical monitoring
- DSMB coordination
- Statistical analysis
- Electronic data capture
- Electronic Trial Master File
- Full service data management
- ClinicalTrials.gov registration and management
- Central lab oversight and coordination
- Site quality assurance audits
- Integrated final Clinical Study Report
Contact us today to learn more about how we can assist your company with clinical services.