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Service Centre

4C – Coimbra Coordinating Centre for Clinical Research

AIBILI - Association for Innovation and Biomedical Research on Light and Image

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

Services

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

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