Clinical Trial line
Through its Clinical Research Centre, Fase 1 promotes, supports and coordinates drug trials, carrying out phase I and IIA clinical trials on behalf of third parties, against payment of a fee.
The Clinical Research Centre designs and implements phase I and IIA clinical trials, (on healthy volunteers or patients), to test new diagnostic and therapeutic agents or advanced, non-invasive medical devices.
The Clinical Research Centre of Fase 1 comprises two operating units, both based in Cagliari and with fully integrated functions:
- Clinical research unit, located at the Brotzu Hospital
- Clinical trial management unit, tasked with registration, validation, data analysis and issue of the final medical report, located at the main office of Fase 1
Goals and objectives
- for pharma companies (sponsors): offer top-rate services for phase I and II trials in terms of quality and productivity
- for trial participants (healthy volunteers and patients): guarantee competency, respect, courtesy and kindness
- for the Sardinian community: foster the creation of a local pool of expertise in the field of clinical research and drug production, professional development in the biomedical field, and generate high-level employment for medical and technical staff.
Resources
- Staff with extensive experience in the performance of clinical trials
- Continuing training and updating programmes
- Extensive database of healthy volunteers for phase I clinical trials
- Large number of patients for selecting participants in phase IIA trials and specific phase I trials
- Specific procedures (Standard Operating Procedures or SOPs) in compliance with international regulatory standards, for managing the standard processes of all trials (relations with the Ethics Committee, definition of protocols and operational processes, regulatory compliance, management of operational relations with labs, quality control)
- Specific non-standard procedures for each type of application as necessary (administering to human subjects, doses, different trial designs).
Facility
For a description of the facility, see section Clinical research unit.
The Clinical Research Centre designs and implements phase I and IIA clinical trials, (on healthy volunteers or patients), to test new diagnostic and therapeutic agents or advanced, non-invasive medical devices.
The Clinical Research Centre of Fase 1 comprises two operating units, both based in Cagliari and with fully integrated functions:
- Clinical research unit, located at the Brotzu Hospital
- Clinical trial management unit, tasked with registration, validation, data analysis and issue of the final medical report, located at the main office of Fase 1
Goals and objectives
- for pharma companies (sponsors): offer top-rate services for phase I and II trials in terms of quality and productivity
- for trial participants (healthy volunteers and patients): guarantee competency, respect, courtesy and kindness
- for the Sardinian community: foster the creation of a local pool of expertise in the field of clinical research and drug production, professional development in the biomedical field, and generate high-level employment for medical and technical staff.
Resources
- Staff with extensive experience in the performance of clinical trials
- Continuing training and updating programmes
- Extensive database of healthy volunteers for phase I clinical trials
- Large number of patients for selecting participants in phase IIA trials and specific phase I trials
- Specific procedures (Standard Operating Procedures or SOPs) in compliance with international regulatory standards, for managing the standard processes of all trials (relations with the Ethics Committee, definition of protocols and operational processes, regulatory compliance, management of operational relations with labs, quality control)
- Specific non-standard procedures for each type of application as necessary (administering to human subjects, doses, different trial designs).
Facility
For a description of the facility, see section Clinical research unit.
