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.
 
Contact person: José Cunha Vaz, MD, PhD; Cecília Martinho, BSc Econ
E-mail: cvm@aibili.pt
Phone:  +351 239 480 104
Center Website:  www.aibili.pt
 
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 is an infrastructure devoted to clinical research with specific equipment, medical and study-nurse staff, allowing enrolment and investigation of patients or volunteers both in the early phases of drug trials and in non-therapeutic studies and involved in full in the design, coordination, monitoring, analysis, reporting and dissemination of clinical trials and other well-designed studies.
The Research Centres are:
- EVICR.net Coordinating Centre
- Coimbra Coordinating Centre for Clinical Research (4C) – Clinical Trial Unit (CTU)
- Clinical Trial Centre (CEC) – Clinical Research Centre (CRC)
- Centre for New Technologies in Medicine (CNTM)
- Coimbra Ophthalmology Reading Centre (CORC)
- Centre for Health Technology Assessment and Drug Research (CHAD)
The Supporting Units are the Administrative Services (SA), the Quality Management Unit (UGQ), the Translational Research and Technology Transfer Unit (UTT), the Information Technology Unit (IT) and the Data Center (DC).
The Centre for Clinical Trials (CEC) is a CRC, has the necessary resources, facilities and procedures to perform clinical studies in any area of clinical research.
The Coimbra Coordinating Centre for Clinical Research (4C) is the CTU to support the development and coordination of Investigator-Driven and Industry-Sponsored Clinical Trials.
Data Centre services are provided by the Information technology Unit (IT) and 4C , namely GCP compliant data management that is necessary for clinical research. The services that are performed by the Data Centre for Investigator Driven Clinical Studies are: design and development eCRF; design and development of CDMA; data entry; IT support; eCRF and CDMA training and data management.
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.

Certification as ECRIN Data Centres and ISO 9001, among others.
It is a private non-profit organisation, founded in 1989, established to support translational research and technology transfer in the health area.
AIBILI is located at the Health Campus of Coimbra University since 1994 and has its own building with 1.454 m2 and state-of-the-art equipment.
AIBILI has a permanent staff of 37 including medical doctors, researchers, engineers, pharmacologists, technicians, trial and project managers, regulatory affairs, trial coordinators and administrative personnel dedicated to clinical trials activity and 8 dedicated to other research activities. 

Clinical trial staff trained on a regular basis in GCP
Communication with scientific community: Website, Mailing list, Internal Newsletter
AIBILI is ISO 9001 certified by the Société Générale de Surveillance (SGS) for the following activities:
Performance of clinical studies;
Planning, coordination, monitoring of clinical research activities;
Health technology assessment;
Grading of eye exams;
Research and development in new technologies for medicine in the areas of imaging, optics and photobiology;
Preclinical studies of new molecules with potential medical use and data centre activities.
Clinical trials are performed in accordance with ICH Guidelines for Good Clinical Practice (GCP).

AIBILI CRC Activities:

- Centralized submission & Implementation: Set-up, Conduct, Completion/ close-out

- Investigational medicinal product management (pharmacy department);

- Management of biological samples

- Quality Control

- Project Management

- Monitoring

- Statistics


AIBILI CTU Services:
- Study design

- Study protocol development

- Inform consent form development

- Case Report Form design

- Database design, validation and implementation

- Clinical sites feasibility

- Standard Operational Procedures development

- Regulatory affairs (submission and reports)

- Contracts negotiation

- Project management

- Monitoring

- Data management

- Pharmacovigilance

- Biostatistics

- Final study report

- Medical writing

- Quality assurance