Clinical Trials
Solutions
CLINICAL TRIALS
Our company has experience in managing activities related to imaging clinical trials, thanks to the professionalism of a specialized and multidisciplinary team and the use of advanced technologies for measuring qualitative and quantitative indices of medical images. Our priority is to ensure prompt response, efficiency, and compliance with regulatory requirements to support the development of new drugs for our clients.
SPECIALIZED IMAGING SERVICES FOR STUDY PROTOCOL DESIGN
We advise our clients on the most suitable imaging metrics to include in the study protocol to highlight the drug’s effectiveness.
Start up phase
* Each phase is automatically managed by our validated Clinical Trial Management (CTM).
- Imaging Manual
Internal documentation developed in compliance with the applicable regulations
Maintenance Phase
* Each phase is automatically managed by our validated Clinical Trial Management (CTM).
- Site qualification
- Imaging Survey
- Database of the used imaging equipment
- Imaging protocol training e imaging questionnaire
- Site specific protocol setup
- Dummy run qualification
- Study images collection
- Quality control and safety
- Endpoints Analysis
- Study monitoring and reporting
CLOSE OUT PHASE
* Each phase is automatically managed by our validated Clinical Trial Management (CTM).
Data reconciliation
Study closure and data archiving
- Raw Images archiving, on request