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 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