Activities
Fase 1 performs the following main activities:
Technical-scientific and marketing potential assessment of new diagnostic and therapeutic agents
- review of the rationale for selecting drugs for clinical trials
- patent due diligence
- scenario and marketing potential analysis
- draft development plan, for preliminary time and cost assessment.
Preclinical development
Pharmacological and clinical testing of new drugs is conducted in several steps aimed at gradually collecting evidence on drug efficacy and tolerability.
Preclinical development can be of four different types, all or part of which may be carried out according to the project’s prior development and studies already performed: these activities – many of which will be carried out in parallel – are implemented after preparation of a detailed development programme. At this stage, Fase 1 performs the following activities:
- Preparation of chemical-pharmaceutical documentation (active principle and finished product): this involves selection of manufacturers of the active principle and finished product, able to supply the product for animal trials and for the first phases of clinical trials, in accordance with the principles of good manufacturing practices (GMP). A key phase is the passage from laboratory scale to semi-industrial scale manufacturing technology, and associated validation of manufacturing and testing methods
- Preparation of non-clinical documentation (pharmacology and toxicology): based on the therapeutic indications of the product under development, appropriate ‘in vitro’ and especially ‘in vivo’ studies must be carried out to demonstrate its efficacy and safety, in accordance with good laboratory practice (GLP) rules.
- Clinical Information (protocol drafting)
- Requests for Authorisation (National Health Institute and Ethics Committee): the request for authorisation includes a summary of the information provided in the previous sections, presented in a specific format.
Clinical development
Fase 1 has a Phase I Clinical research centre comprising two operating units. both based in Cagliari and with fully integrated functions:
- Clinical trial management unit, tasked with registration, validation, data analysis and presentation of the final medical report, based in the offices of Fase 1 srl in via Carbonazzi, 14
- Clinical research unit, located on the 11th floor of the G. Brotzu Hospital, ranked as a national-level, high specialisation hospital by a Decree of the Prime Minister dated 8/04/1993 and delivering first-rate healthcare to Sardinian citizens especially in specialised areas, such as heart surgery and organ transplant.
The Brotzu Hospital’s strong focus on advances in healthcare makes it an ideal partner for Fase 1. The G. Brotzu Hospital collaborates with Fase 1 srl in the implementation of clinical trials providing:
- a clinical facility fully integrated within the hospital, sized for the performance of phase 1 clinical trials on human subjects
- ward facilities for inpatients and associated services
- specialised lab and pharmacy services and other specialised services
- medical and nursing staff
- general medical services such as ICU, emergency room, stroke unit, coronary care unit and other on-demand services.
All the above services have the following characteristics:
- specific procedures (Standard Operating Procedures or SOPs) 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, etc.)
- specific non-standard procedures for each type of application as necessary (administering to human subjects, doses, different trial designs, etc.).
Scientific training and information
In order to complement its core activities with appropriate supporting initiatives, Fase 1 collaborates with the local universities to promote the development of scientific know-how and advanced knowledge in the field of clinical trial and drug development.
In this area, Fase 1 plans and implements several initiatives, such as:
- master course in clinical trials
- award of study grants to young doctors wishing to specialise in clinical trials
- career development within universities and the public health system
- science awareness events and activities.
Technical-scientific and marketing potential assessment of new diagnostic and therapeutic agents
- review of the rationale for selecting drugs for clinical trials
- patent due diligence
- scenario and marketing potential analysis
- draft development plan, for preliminary time and cost assessment.
Preclinical development
Pharmacological and clinical testing of new drugs is conducted in several steps aimed at gradually collecting evidence on drug efficacy and tolerability.
Preclinical development can be of four different types, all or part of which may be carried out according to the project’s prior development and studies already performed: these activities – many of which will be carried out in parallel – are implemented after preparation of a detailed development programme. At this stage, Fase 1 performs the following activities:
- Preparation of chemical-pharmaceutical documentation (active principle and finished product): this involves selection of manufacturers of the active principle and finished product, able to supply the product for animal trials and for the first phases of clinical trials, in accordance with the principles of good manufacturing practices (GMP). A key phase is the passage from laboratory scale to semi-industrial scale manufacturing technology, and associated validation of manufacturing and testing methods
- Preparation of non-clinical documentation (pharmacology and toxicology): based on the therapeutic indications of the product under development, appropriate ‘in vitro’ and especially ‘in vivo’ studies must be carried out to demonstrate its efficacy and safety, in accordance with good laboratory practice (GLP) rules.
- Clinical Information (protocol drafting)
- Requests for Authorisation (National Health Institute and Ethics Committee): the request for authorisation includes a summary of the information provided in the previous sections, presented in a specific format.
Clinical development
Fase 1 has a Phase I Clinical research centre comprising two operating units. both based in Cagliari and with fully integrated functions:
- Clinical trial management unit, tasked with registration, validation, data analysis and presentation of the final medical report, based in the offices of Fase 1 srl in via Carbonazzi, 14
- Clinical research unit, located on the 11th floor of the G. Brotzu Hospital, ranked as a national-level, high specialisation hospital by a Decree of the Prime Minister dated 8/04/1993 and delivering first-rate healthcare to Sardinian citizens especially in specialised areas, such as heart surgery and organ transplant.
The Brotzu Hospital’s strong focus on advances in healthcare makes it an ideal partner for Fase 1. The G. Brotzu Hospital collaborates with Fase 1 srl in the implementation of clinical trials providing:
- a clinical facility fully integrated within the hospital, sized for the performance of phase 1 clinical trials on human subjects
- ward facilities for inpatients and associated services
- specialised lab and pharmacy services and other specialised services
- medical and nursing staff
- general medical services such as ICU, emergency room, stroke unit, coronary care unit and other on-demand services.
All the above services have the following characteristics:
- specific procedures (Standard Operating Procedures or SOPs) 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, etc.)
- specific non-standard procedures for each type of application as necessary (administering to human subjects, doses, different trial designs, etc.).
Scientific training and information
In order to complement its core activities with appropriate supporting initiatives, Fase 1 collaborates with the local universities to promote the development of scientific know-how and advanced knowledge in the field of clinical trial and drug development.
In this area, Fase 1 plans and implements several initiatives, such as:
- master course in clinical trials
- award of study grants to young doctors wishing to specialise in clinical trials
- career development within universities and the public health system
- science awareness events and activities.
