ABOUT 4C

The Coimbra Coordinating Centre for Clinical Research 4C is a structure to support Investigator-Initiated and Industry-Sponsored Clinical Research complying with ICH GCP - Good Clinical Practice Guidelines and European regulations. 4C provides the necessary logistical support to perform multinational clinical research in Europe, with special emphasis on Investigator-Initiated Research (IIR).

SERVICES
  • Development and overall management of clinical research studies
  • Investigator-initiated clinical study (IDCTs) support, namely research applications
  • Submission to the Regulatory Authorities
  • Regulatory issues
  • Data Management
  • Monitoring
  • Statistical and Reporting
PRE-STUDY SERVICES
  • Study Design
  • Protocol Development
  • Informed Consent Form
  • Electronic Case Report Form (performed by Data Centre)
  • Clinical Sites Feasibility Assessment
  • Master File / Investigator File Development
  • Standard Operational Procedures Development
  • Recording in Clinical Research Platforms
  • Submission to the Regulatory Authorities (RA)
  • Contracts Elaboration

 

IN-STUDY SERVICES
  • Overall Management and Coordination
  • Monitoring
  • Data Management and Validation
  • Periodical Reports to the Sponsor and/or RA
  • Pharmacovigilance (performed by CHAD)
  • Auditing

 

Post-Study Services
  • Database Locking, Cleaning and Transferring
  • Data Analysis
  • Final Study Report
  • Scientific Publication
DATA CENTRE SERVICES

AIBILI’s Data Centre services are provided by the Information Technology Unit (IT) and 4C.
The IT / Data Centre is a structure to support Investigator Initiated Research providing Data Management and Electronic Data Capture Solutions compliant with ECRIN Data Centre Certification requirements.
The services performed by AIBILI Data Centre are: design and development eCRF; design and development of CDMA; data entry; IT support; eCRF and CDMA training and data management.
AIBILI has the ECRIN Data Centre Certification since April 2016, meeting the ECRIN requirements for IT and Data Management within clinical trials. AIBILI 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, “Requirements for Certification of ECRIN Data Centres” and ISO 9001, among others.

  • Clients

    ‣ Alimera

    ‣ Allergan

    ‣ Atral

    ‣ Bayer

    ‣ Novartis

    ‣ Pfizer

    ‣ Théa

  • Partners

    ‣ Champalimaud Foundation

    ‣ CHUC - Coimbra University Hospital

    ‣ ECRIN

    ‣ EVI

    ‣ EVICR.net

    ‣ Faculty of Medicine, UC

    ‣ ICBR, UC

    ‣ ICNAS, UC

    ‣ INFARMED

    ‣ PtCRIN

CONTACTS

Sandrina Nunes

Phone: +351 239 480137
Fax: +351 239 480117

mail: 4c@aibili.pt