ABOUT 4C
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, with special emphasis on Investigator-Initiated Research (IIR).
- Development and overall management of clinical research studies, including clinical trials and clinical investigation with medical devices
- Investigator-initiated clinical study (IDCTs) support, namely research applications
- Submission to the Regulatory Authorities
- Regulatory issues
- Data Management
- Monitoring
- Statistical and Reporting
- Pharmacovigilance
PRE-STUDY SERVICES
- Study Design
- Statistical Plan
- Protocol and Informed Consent Form Development
- Electronic Case Report Form (eCRF) Development (performed by Data Centre)
- Database Validations and Implementation (performed by Data Centre)
- 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
IN-STUDY SERVICES
- Overall Management and Coordination
- Investigational Medicinal Product and Medical Device Management
- Monitoring
- eCRF Management and Support (performed by Data Centre)
- Data Management and Validation (performed by Data Centre)
- Periodical Reports to the Sponsor and/or RA
- Pharmacovigilance and Risk Management
- Auditing
Post-Study Services
- Database Locking, Cleaning and Transferring (performed by Data Centre)
- Biostatistics
- Data Analysis
- Final Study Report
- Medical Writing
- Scientific Publication
- Archiving
DATA CENTRE SERVICES
AIBILI’s Data Centre services are provided by the Information Technology Unit (IT) and 4C. The IT / Data Centre is a structure to support Investigator Initiated Research providing Data Management and Electronic Data Capture Solutions compliant with ECRIN Data Centre Certification requirements. The services performed by AIBILI Data Centre are: design and development eCRF; design and development of CDMA; data entry; IT support; eCRF and CDMA training and data management. AIBILI has the ECRIN Data Centre Certification since April 2016, meeting the ECRIN requirements for IT and Data Management within clinical trials. AIBILI Data Centre services comply with EU Directive 2001/20/EC for the implementation of GCP, Good practice for computerised systems in regulated GXP environments, PIC/S Inspectors Guide, FDA Guidance for Industry, Computerized Systems Used in clinical trials and 21 CFR Part 11, GAMP 5, ISO27000, “Requirements for Certification of ECRIN Data Centres” and ISO 9001, among others.
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Director
Joana Tavares
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Scientific Coordinators
Conceição Lobo
José Cunha-Vaz
Rufino Silva
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Consultants
Alexandra Escada
Carlos Santos
Jorge Fortuna
Sebastião Silva
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Project Managers
Cecília Martinho
Cândida Dias
Daniel Fernandes
Inês Aires
Inês Tavares
Joana Tavares
Rita Fernandes
Rita Ribeiro
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Statisticians
Débora Ferreira
Rita Coimbra
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Investigator
Daniel Figueiredo
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Safety Managers
Inês Aires
Inês Tavares
Rita Ribeiro
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UFC Coordinator
M. Liseta Lemos
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UFC Research Assistants
Inês Tavares
Joana Abrantes
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Clinical Trial Assistants
Daniela Cravo
Liliana Carvalho
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Monitors
Cândida Dias
Inês Tavares
Rita Ribeiro
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Secretary
Liliana Carvalho
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Administrative Technician
Laura Seco
