General info for Apheresis Centres
Centres cooperating with our company must meet the following criteria:
- They must be certified by National Regulatory Authority as National Drug Authority or by National Regulatory Authority for Blood and Transfusion or National Authority for Human Cells and Tissues Regulation according to their national legislative.
- The certification must contain required scope of services (collection of Peripheral Blood Mononuclear Cells, Autologous Mononuclear Cells, Autologous Lymphocytes or a category related to the above mentioned kinds of cells)
- They work routinely on separators Spectra Optia or Amicus.
- They must be adequately trained and their personnel must be experiencedin the required field.
- They must be able to offer and keep sufficient time capacity.
The evaluation of centre’s suitability for clinical trial is based on SOTIO Apheresis Centre Questionnaire which is sent to the centrein the initial phase of negotiations.
Apheresis Centre Questionnaire serves as a basic document for further survey of regulatory, quality, service-related, technical and personnel conditions of the identified Apheresis Centre.
Apheresis Centre Questionnaire includes:
- Verification of Apheresis Centre’s scope of certification and state of their accreditation, information about the legislative frame for collection and release of Leukapheresis unit.
- Verification of previous experiences with cell collections.
- Verification of technical equipment and suitable collection and storage area.
- Verification of staff possibilities and experiences, Apheresis Centre’s capacity for SOTIO collections.
- Information whether the Apheresis Centre performs Leukapheresis evaluation visit and can provide central line/catheter insertion if needed
- Information about contact details and Apheresis Centre responsible person
- Verification whether general scope of SOTIO-required services is acceptable for the Apheresis Centre
Confidentiality Disclosure Agreement (CDA) should be also obtained.
When a completed Apheresis Centre Questionnaire is returned, SOTIO Apheresis Network Manager is responsible for its evaluation and decides whether contract negotiations are started. Initial visit at the Apheresis Centre and initial audit/observation of site is performed before a start of cooperation. The purpose of the audit is to confirm readiness for collaboration start and to identify any potential additional requirements that must be fulfilled before the first collection and to train staff in SOTIO-related processes.
Regular audits and monitoring visits are performed at active Apheresis Centres and represent a system of control of compliance to relevant SOTIO manuals and documentation handling.