The ICMED Srl Consulting Center is the international reference for consulting and support activities for healthcare facilities, research centers and pharmaceutical companies operating in the transplant and cell therapy sector.
To contact the Consulting Center:
STEM CELL TRANSPLANT PROGRAMS
All Stem Cell Transplant Programs must comply with the requirements of the FACT-JACIE international standard.
ICMED Srl supports the centers for activities related to:
- a) start-up of the transplant program
- b) development of organizational and quality systems, including support in the design and implementation of the document system
- c) training of personnel in relation to accreditation requirements
- d) preparation for the FACT-JACIE inspection
- e) execution of internal audits aimed at maintaining quality
- f) maintenance of the quality system, through support in the management of the Management Review and in the periodic evaluation of the indicators.
CAR-T UNIT, CELL AND GENE THERAPY ORGANIZATION
ICMED Srl supports health facilities in the construction of cell and gene therapy centers, with the passing of qualification inspections.
In particular, the services offered concern:
- staff training
- organizational system development
- development of the document system
- carrying out internal audits
- support to the qualification of the center by the GMP facilities
- support for the construction of infrastructures compliant with GMP regulations
ICMED Srl offers the following services for biobanks:
- implementation of the quality management system in compliance with current regulations, in particular in compliance with ISO / DIS 20387: 2017 (E)
- support for the development of standard operating procedures (SOPs) and best practices in the field of collection, processing, storage, distribution and use of human and non-human biological material (e.g., animals, environment) for clinical research purposes and protection of biodiversity
privacy and data protection, in implementation of the 2016/679 European Regulation
- support for compliance relating to the regulations relating to the financial management of research biobanks and related application tools (e.g., business plan, cost recovery plan) and to the regulations relating to disaster recovery, culling and legacy and related application tools (e.g., disaster recovery plan)
NETCORD - BANKS OF THE CORD
The FACT-NETCORD standard arises from the partnership between the FACT (International Society for Cellular Therapy and American Society for Blood and Marrow Transplantation) and the NETCORD network, which connects different cord banks. Through the scientific guidelines of the FACT-NETCORD, these institutions supported the cord banks and the laboratories to which they refer, in achieving the highest quality standards. Compliance with standards allows the design and implementation of a quality system for all areas involved: from the collection of placental blood to handling in individual laboratories. ICMED offers its experience to cordon banks to obtain accreditation in the shortest possible time.
EFI - HLA LABORATORIES
ICMED Srl offers advice to HLA typing centers for EFI accreditation.
The EFI - European Federation for Immunogenetics has developed a standard with the aim of improving the quality of the laboratories that perform histocompatibility tests.
The EFI standard includes the different requirements that characterize an HLA laboratory, in particular:
a) organizational requirements
b) structural requirements
c) requirements relating to personnel training
d) patient management methods
e) management of laboratory protocols
The EFI certificate is mandatory for all HLA typing laboratories that run their business for bone marrow and / or organ transplants.
GMP - PHARMACEUTICAL WORKSHOPS
CMED srl offers consultancy services addressed to public and private pharmaceutical workshops, companies in the pharmaceutical and biotechnological sectors, manufacturers of medical devices.
The goal of the consultancy is to ensure compliance with GMP. In particular, the services offered concern:
GMP risk assessment
design and development of the quality system
development of documentation
development of the registration dossier
development of the dossier for MD
GCP - CLINICAL TRIAL OFFICE
IICMED offers consultancy services focused on GCP (Good Clinical Practice).
GCPs are international quality standards for the design and implementation of clinical trials involving humans.
ICMED consultancy concerns:
a) implementation of a quality system for the clinical study
b) support in drafting the project plan
c) identification of the regulations in force applicable to the clinical trial
d) development of study documentation management systems
e) staff training on the correct management of clinical studies)
ASSISTED FERTILIZATION CENTERS (PMA)
PMA (Medically Assisted Procreation) centers in compliance with current legislation both nationally (Legislative Decree 191/2007 and Legislative Decree 16/2010) and internationally must comply with the organizational, technical-scientific quality requirements , structural and formative.
In this context, ICMED has developed a methodology aimed at implementing the quality system at these centers, developing an organizational system capable of verifying the level of quality both from a managerial and clinical point of view.
ICMED has developed a consultancy service aimed at realities that provide home care both in the general (ADI) and in the specialist field (eg hematology).
Thanks to the experience of its experts, the consultancy is articulated through targeted interventions aimed at:
a) verify compliance with current legislation in the field of home care
b) support the realities in the drafting of agreements with hospitals and / or ASL of r
c) develop specific quality systems for home care realities
d) prepare the centers for the SASDO home care certification specific for home care services.
Transfusion services must implement quality systems in compliance with current legislation. ICMED sr.l. offers its experience and professionalism to design and develop organizational systems compliant with both national and international transfusion regulations.