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4C // Coimbra Coordinating Centre for Clinical Research


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). 4C providing the following services:

 

Pre-Study Services

  • Study Design
  • Protocol Design
  • Inform Consent Form
  • Electronic Case Report Form (performed by the IT - Data Centre, in-house at AIBILI)
  • Clinical Sites Feasibility
  • Standard Operational Procedures Development
  • Submission to the Regulatory Authorities (RA)
  • Contracts Elaboration

In-Study Services

  • Study Management and Coordination
  • Monitoring / Auditing
  • Data Management
  • Periodical Reports to the Sponsor and/or RA
  • Data Validation
  • Pharmacovigilance (performed by CHAD, in-house at AIBILI)

Post-Study Services

  • Data Analysis
  • Final Study Report
  • Scientific Publication

4C is currently staffed by one Scientific Director and an Executive Director, four medical consultants, six project/clinical trial managers (CRA), one statistician and two administrative assistants.

4C is the coordinating infrastructure for clinical trials of the EVICR.net.

 

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.

Services

  • Investigator-driven clinical trials (IDCTs) support
  • Study documents elaboration
  • Submission to the regulatory authorities
  • Data Management
  • Education and Training
  • Regulatory issues
  • Statistical analysis
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