Service Centre category(ies)
Clinical Research / Clinical Trials
Description of the Service Centre
The Coimbra Coordinating Centre for Clinical Research 4C is a structure to support Investigator-Initiated and Industry-Sponsored Clinical Research complying with ICH GCP - Good Clinical Practice Guidelines and European regulations, namely Clinical Trials Regulation (Regulation (EU) No 536/2014), Medical Devices Regulation (Regulation (EU) No 2017/745) and ISO 14155. 4C provides the necessary logistical support to perform multinational clinical research in Europe.
Service Centre web address
https://www.aibili.pt/units-centres/4c/
Contact person's name
Joana Tavares
Contact person's e-mail
jftavares@aibili.pt
Contact person's telephone
35129480137
Last edited on
2022-12-16 14:39:21
Service
PRE-STUDY SERVICES
Available for external use?
Yes
Comments
Study Design Statistical Plan Protocol and Informed Consent Form Development Electronic Case Report Form Development (performed by Data Centre) Database Validations and Implementation Clinical Sites Feasibility Assessment Master File / Investigator File Development Standard Operational Procedures Development Recording in Clinical Research Platforms Submission to the Regulatory Authorities (RA) Contracts Elaboration
Service
IN-STUDY SERVICES
Available for external use?
Yes
Comments
Overall Management and Coordination Investigational Medicinal Product and Medical Device Management Monitoring Electronic Case Report Form Management and Support Data Management and Validation Periodical Reports to the Sponsor and/or RA Pharmacovigilance and Risk Management Services Auditing
Service
POST-STUDY SERVICES
Available for external use?
Yes
Comments
Database Locking, Cleaning and Transferring Biostatistics Data Analysis Final Study Report Medical Writing Scientific Publication Archiving
