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.

AIBILI

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

Location: Coimbra, Portugal    Certification period: 2016 - 2020

Please click here to see AIBILI  services or visit the  website 


 

NOVA-CRU

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.

 




DATA CENTER CERTIFICATION
ECRIN-ERIC has a certification program of Data Centers for Clinical Research Units as part of the ECRIN quality services.
ECRIN Data Centre Certification is a process that identifies data centres providing high-quality, efficient and compliant data and information technology (IT) management for multinational clinical research. ECRIN strongly recommends the use of certified data centres for the multinational trials it supports.

Read more about Data Center Certification and contact your European Correspondent.