C2ICB – Coordinating Center of Clinical Research of Beiras
Director: Miguel Castelo-Branco (email@example.com)
The mission of C2ICB consists of supporting the development of pharmaceuticals, medical devices and organizational aspects by providing a variety of innovative services to institutions and companies whose focus is developing and transferring their projects to the clinical practice.
C2ICB is prepared to coordinate research projects, management, processing and follow-up on ongoing trials involving:
- Support to the project promoter in defining the target profile of the product and in the development of the pre-clinical and regulatory plan;
- The execution of the complete service, from the development of the clinical trial protocol to the preparation of the final report:
- Development of the requests for scientific and regulatory advice by the competent authorities (INFARMED, FDA, EMA, and so on) if necessary;
- Preparation of the application for the approval of the clinical trial by INFARMED, CEIC and CNPD;
- Conduction of the clinical trial, according to the best ethical standards and Good Clinical Practices;
- Data management according to the most demanding regulatory requirements;
- Possibility of using gold-standard software for the analysis and organization of the trial data according to CDISC;
- Epidemiological advice, including sample size;
- Final Clinic Study Report ready for submitting to the most rigorous international regulatory authorities.
- Support to the research, namely: statistics, translations, dissemination, training, legal and management;
- Fostering partnerships with other hospitals, health care units and palliative care units, providing access to the target patients.