Academic CTUs CROs

PtCRIN academic CTUs/CROs

PtCRIN academic CTUs/CROs 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. PtCRIN CTUs/CROs 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,replica uhren data management, etc.).

PtCRIN CTUs/CROs are non-profit organisations that collaborates with academy and industry, providing comprehensive consultancy and services to clinical research

2CA-Braga is an academic CTU/CRO that aims to promote, encourage and facilitate the development of academic-driven or investigator-driven clinical research though a multidisciplinary supporting infrastructure. 2CA-Braga provides support through all stages according to GCPs.

The services performed by 2CA-Braga include:

Design a review of protocol and methologies
Scientific and regulatory consulting
Support financial evaluation and cost estimates
Regulatory and ethics submissions
Coordination and monitoring
Monitoring of adverse events
Data management
Biostatistics

Location: Braga, Portugal

Please click here to see 2CA-Braga services or visit the website.

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.

The services performed by AIBILI CTU include:

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
Health Technology Assessment

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

CRU²C is an academic venture between Institute of Nuclear Sciences Applied to Health (ICNAS), ICNAS-Produção and Laboratory for Biostatistics and Medical Informatics of Faculty of Medicine of University of Coimbra. CRU²C offers non-for- profit rates expertise to support all stages of clinical research, complying with ethics and regulatory authorities, in order to successfully reach high quality, efficient and sustainable clinical research.

The services performed by CRU²C include:

Support on Funding Application
Assistance in the preparation of the study protocol
Budget estimation
Regulatory Affairs
Clinical Study Management & Monitoring
Biostatistics and Data analysis

Location: Coimbra, Portugal

Please click here to visit CRU²C website.

NOVA Clinical Research Unit (NOVA CRU) is a joint venture between NOVA Medical School (NMS) and NOVA Information and Management School (NOVA-IMS) from Universidade NOVA de Lisboa. NOVA CRU is a service provider unit offering at non-for-profit rates expertise and support for the design and management of multicenter randomized controlled trials, and other complex studies, according to the standards required by ethics and regulatory authorities.

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 include:

Study protocol development
Gaining ethical and regulatory authorities
Case Report Forms (CRFs) design
Biostatistics plan
Clinical Trial management
Study Coordination
Database design
Support Research Team in loco
Monitoring
Database Management
Quality Management
Data Management
Data Analysis

Location: Lisbon, Portugal

Please click here to see NOVA CRU services or visit the website.

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

CETERA support investigator-initiated research providing data management and electronic data capture solutions. The services performed by CETERA 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 CETERA services or visit the website

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