Stem Cell Transplant Programs
All Stem Cell Transplant Programs must comply with the requirements of the international FACT-JACIE standard.
ICMED S.r.l. supports centres for activities related to:
- Transplant program start-up
- Development of organizational and quality systems, including support in the design and implementation of the document system
- Staff training regarding accreditation requirements
- Preparation for FACT-JACIE inspection
- Execution of internal audits aimed at quality maintenance
- Quality system maintenance, through support in Management Review and periodic evaluation of indicators
ICMED S.r.l. supports centres for activities related to:
- Transplant program start-up
- Development of organizational and quality systems, including support in the design and implementation of the document system
- Staff training regarding accreditation requirements
- Preparation for FACT-JACIE inspection
- Execution of internal audits aimed at quality maintenance
- Quality system maintenance, through support in Management Review and periodic evaluation of indicators
CAR-T Unit, Cell and Gene Therapy
ICMED S.r.l. supports healthcare facilities in establishing cell and gene therapy centres, with the passing of qualification inspections.
In particular, the services offered include:
- Staff training
- Development of the organizational system
- Development of the document system
- Execution of internal verifications
- Support for centre qualification by GMP facilities
- Support for the construction of GMP-compliant infrastructure
In particular, the services offered include:
- Staff training
- Development of the organizational system
- Development of the document system
- Execution of internal verifications
- Support for centre qualification by GMP facilities
- Support for the construction of GMP-compliant infrastructure
Biobanks
ICMED S.r.l. offers for biobanks the following services:
- Implementation of quality management system in compliance with current regulations, particularly ISO/DIS 20387:2017
- Support for the development of SOPs and best practices for collection, processing, storage, distribution and use of biological material
- Privacy and data protection, in compliance with European Regulation 2016/679
- Support for compliance with regulations regarding financial management of research biobanks
- Implementation of quality management system in compliance with current regulations, particularly ISO/DIS 20387:2017
- Support for the development of SOPs and best practices for collection, processing, storage, distribution and use of biological material
- Privacy and data protection, in compliance with European Regulation 2016/679
- Support for compliance with regulations regarding financial management of research biobanks
NetCord - Cord Blood Banks
The FACT-NETCORD standard was born from the partnership between FACT and the NETCORD network. Through the FACT-NETCORD scientific guidelines, these institutions support cord blood banks and laboratories in achieving the highest quality standards. ICMED offers its expertise to cord blood banks to obtain accreditation in the shortest possible time.
EFI - HLA Laboratories
ICMED S.r.l. offers consulting to HLA typing centres for EFI (European Federation for Immunogenetics) accreditation. The EFI standard includes organizational, structural requirements, staff training requirements, patient management and laboratory protocol management. The EFI certificate is mandatory for all HLA typing laboratories.
GMP - Pharmaceutical Manufacturing
ICMED S.r.l. offers consulting services to public and private pharmaceutical facilities, pharmaceutical, biotechnology and medical device companies.
Services offered include:
- GMP risk assessment
- Design and development of the quality system
- Documentation development
- Registration dossier development
- MD dossier development
Services offered include:
- GMP risk assessment
- Design and development of the quality system
- Documentation development
- Registration dossier development
- MD dossier development
GCP - Clinical Trial Office
ICMED offers consulting services focused on GCP (Good Clinical Practice), international quality standards for the design and conduct of clinical trials.
Consulting includes:
- Implementation of a quality system for clinical studies
- Support in drafting the project plan
- Identification of applicable current regulations
- Development of documentation management systems
- Staff training on proper management of clinical studies
Consulting includes:
- Implementation of a quality system for clinical studies
- Support in drafting the project plan
- Identification of applicable current regulations
- Development of documentation management systems
- Staff training on proper management of clinical studies
Assisted Reproduction Centres (ART)
ART centres must comply with quality requirements of an organizational, technical-scientific, structural and training nature. ICMED has developed a methodology to implement the quality system at such centres, developing an organizational system capable of verifying the quality level from both a management and clinical perspective.
Transfusion Services
Transfusion services must implement quality systems in compliance with current regulations. ICMED S.r.l. offers its expertise and professionalism to design and develop organizational systems compliant with both national and international transfusion regulations.
Continuous Support to Facilities
ICMED has developed an online and in-person continuous support service for requesting facilities. Through subscribing to this service, you will have access to the following benefits:
- Online or in-person support for specific client needs
- Use of the ICMED scientific network
- Participation in international research projects
- Online or in-person support for specific client needs
- Use of the ICMED scientific network
- Participation in international research projects