The Phase I
Unit has been operating since 1996. We
provide a full integrated service (clarity, capacity,
and commitment) in Phase I clinical research.
Volunteer screening, the experimental phase and
subject's follow up is carried out at Dos
de Maig Hospital in Barcelona.
The unit is certified (nº BPC06-128i) in
GCP (Good Clinical Practices) by the CA (Competent
Authority) Generalitat de Catalunya.
FIELDS OF ACTION
• Study design and
medical writting/review clinical protocols
• CRF (Case Report Form) design and production
• CTA (Clinical Trial Application): EudraCT,
IEC, CA
• Volunteer database (registered at the Data Protection Agency)
• Volunteer selection
• Experimental phases
• Bioanalysis/Kinetic analysis
• Data management and statistical analysis
• CSR (Clinical Study Report) medical writting
• Study File archive
• Scientific advice/Expert report
SERVICES AND FACILITIES
• 32 beds and leisure
/ rest areas
• IEC: Hospital General de L'Hospitalet CEIC (Clinical Research Ethics Committee)
• ICU next to the Unit
• Hospital Pharmacy Service
• Project management (from protocol design
to the CSR)
• Specialised medical team
• Specialised nurses
• Unit devices: Synchronised clocks / digital
ECGs (with files transformable into XML format (in
accordance with FDA criteria), pulse oximetry,
centrifuges, freezers (-80ºC), dry ice.
• SOPs (Standard Operating Procedures)
• Quality Assurance (GCP audits in accordance
with ICH, BPCs
 and
ISO 9001:2008)
• Equipment calibration and control
• Functional integration with the laboratory units (central and
hospital): |
