The Coimbra Coordinating Centre for Clinical Research (4C) is a qualified structure to support Investigator-Initiated and Industry-Sponsored Clinical Trials activities complying with ICH GCP (Good Clinical Practice Guidelines) and the EU Clinical Trials Directive.

Services provided:

Pre-Study Services
- Study Design
- Protocol Design
- Inform Consent Form
- Standard Operational Procedures Development
- Submission to the Regulatory Authorities (RA)
- Contracts Elaboration

In-Study Services
- Study Managment and Coordination
- Monitoring / Auditing
- Data Managment
- Periodical Reports to the Sponsor and/or RA
- Pharmacoviligance
- Data Validation

Post-Study Services
- Data Analysis
- Final Study Report
- Regulatory Reports
- Scientific Publication

These services are also provided by 4C to EVICR.net - a network of European Ophthalmological Clinical Research Sites, which AIBILI is the Coordinating Centre.

The 4C has the support of the Champalimaud Foundation as the core unit of AIBILI for C-TRACER activities. 

Services

• Investigator-driven clinical trials (IDCTs) support
• Study documents elaboration
• Submission to the regulatory authorities
• Data Management
• Education and Training
• Regulatory issues
• Statistical analysis