CTUs in Portugal

Clinical Trial Units bring together experts needed to conduct a clinical trial, including physicians, statisticians and study managers. They operate as the interface between all the stakeholders in clinical trials. CTUs can provide either general or particular services in areas such as (e.g. oncology, ophthalmology, etc.) or even provide specific assistance (e.g. statistics, protocol design, monitoring, pharmacovigilance, data management, etc.).

Clinical Trial Units (CTUs) manage clinical trials, prognostic studies, diagnostic studies, and meta-analyses. They also deal with the design, organization, logistics of the study, participate in centre selection, data management, monitoring, data analysis, pharmacovigilance and reporting.


Association for Innovation and Biomedical Research on Light and Image  is a Research Technology Organisation in the health area dedicated to the development and clinical research of new products for medical therapy and diagnostic imaging. As a Clinical Research Center (CRC) & Clinical Trial Unit (CTU), AIBILI has dedicated facilities to perform clinical research according to ICH-GCP Guidelines. AIBILI has also an Ophthalmology Reading Centre and a Centre for Health Technology Assessment and Drug Research.

AIBILI Data Centre

AIBILI has a Data Centre Certification from ECRIN. The AIBILI Data Centre is a structure to support investigator-initiated research providing data management and electronic data capture solutions. The services performed by AIBILI ECRIN Data Centre include:

• design and development of electronic case report forms (eCRFs)
• design and development of clinical data management applications (CDMA)
• data entry
• IT support
• eCRF and CDMA training and data management

Certification period: 2016-2020 Certification Renewal: 2021-2024. AIBILI data centre continues to demonstrate its capacity to meet the ECRIN IT/DM standard (version 4.0 from April 2018), being the only Data Centre in the Iberian Peninsula with this certification.

Location: Coimbra, Portugal

Please click here to see AIBILI  services or visit the  website 


 

NOVA Clinical Research Unit (NOVA-CRU) is a joint venture between NOVA Medical School (NMS) and NOVA Information and Management School (IMS) and is the preferential point-of-contact for planning and set up of clinical trials. As a Clinical Trial Unit (CTU), NOVA-CRU is available to provide support to academic led trials and Industry-Sponsored Clinical Trials.

NOVA-CRU Data Centre

NOVA-CRU is an academic structure to support investigator-initiated research providing data management and electronic data capture solutions. The services performed by NOVA-CRU as Data Centre include:

•    Database design and data management 
•    To provide a range of data management services and to enable the creation of systems that provide a successful infrastructure for clinical trials 
•    Database design, development and validation
•    Web-based data entry systems
•    Central data entry 
•    Data query management
•    Provision of cleaned and locked datasets
•    Archiving of databases
•    Data cleaning
•    Data analysis – interim and final results

Location: Lisbon, Portugal

Please click here to see NOVA-CRU services.
 


AIDFM-CETERA is a Portuguese Academic CTU, founded in 2013 and based at the Lisbon Academic Medical Centre (CAML). A key strength of AIDFM-CETERA is the academic expertise and integrity of its scientific team which lies in a global coverage with different stakeholders. AIDFM-CETERA provides a wide range of services, from scientific consulting and regulatory expertise to the management of national and international clinical research trials

AIDFM-CETERA Data Centre

AIDFM-CETERA support investigator-initiated research providing data management and electronic data capture solutions. The services performed by AIDFM-CETERA as Data Centre include:
•   Feasibility: site assessment, selection and identification
•   Investigator Contract Negotiation
•   Study Full Regulatory Submission
•   Clinical Monitoring
•   Project Management
•   Medical Monitoring
•   Scientific Advisory and Consultancy
•   Translation
•   Medical Writing
•   Regulatory Affairs

Location: Lisbon, Portugal

Please click here to see AIDFM-CETERA