The Coimbra Coordinating Centre for Clinical Research (4C) is a platform/structure qualified to support Investigator-Initiated and Industry-Sponsored Clinical Trials by providing the following services:

- Protocol design and statistical planning
- Elaboration of the necessary documents for the submission of the clinical trial
- Submission to the regulatory authorities
- Coordination and implementation of the clinical trial
- Monitoring
- Quality control
- Data management
- Statistical analysis
- Periodical reports to the sponsor and/or regulatory authorities
- Final clinical trial report
- Publication support

Within the EVICR.net Network the 4C is responsible for the:
- management of the Network
- certification of the Clinical Sites with SOP implementation
- planning and management of investigator-driven clinical trials (IDCT)
- education and training
- regulatory issues

The 4C had the support of Champalimaud Foundation as the core unit of AIBILI for C-TRACER activities. It has also received support from the Merck Sharp & Dohme Foundation.

EVICR.net - European Vision Institute Clinical Research Network
The 4C is also responsible for the coordination and management, at an international level, of the EVICR.net - European Vision Institute Clinical Research Network - a network of European Ophthalmology Clinical Research Sites, dedicated to perform clinical research in ophthalmology with the highest standards of quality.

This Network performs clinical trials efficiently and professionally, striving for excellence in clinical research following the European and International Directives for clinical trial research (Declaration of Helsinki, ICH GCP Guidelines, Clinical Directive EU and local legislations). This is accomplished by the certification of the Clinical Sites that fulfil Basic Requirements and have adopted common Standard Operating Procedures (SOPs) - EVICR.net organizational SOPs in order to perform clinical trials according to ICH GCP Guidelines. All Clinical Sites are subject to an independent Evaluation Visit.

This Network is a professional and attractive resource to the Pharmaceutical Industry when planning to perform multicentric clinical trials in ophthalmology in Europe.
It is an efficient way to identify experienced qualified professional Clinical Sites with expertise and well equipped to perform Clinical Trials in Ophthalmology according to ICH GCP Guidelines.

At the moment EVICR.net has 76 members from 16 European countries.

For more information about EVICR.net please visit: www.evicr.net

Services