Page 63 - SaxoCell Annual Report 2021

Summary of SaxoCell CLINICS tasks and services

Clinical trial support
Feasibility: Discussion of planned study projects involving relevant stakeholders, such as the
project team, advisory board and possibly regulatory authorities.
Assessment of regulatory framework: SaxoCell CLINICS supports with regulatory
classification of a planned study and with study Sponsor identification (according to AMG).
Start-up support for clinical studies: The SaxoCell CLINICS platform supports the project
network with advice on study management set-up, the development of essential trial
documents and the choice of an appropriate study management organization/CRO. SaxoCell
CLINICS accompanies clinical study projects during this transition. SaxoCell Platforms

Education and training
SaxoCell CLINICS organizes educational meetings on clinical trial management for the project
partners. The platform works with internal and external partners in order to offer comprehensive
training according to the project partners’ needs.

Consulting and network formation
Networking within the SaxoCell cluster and with regional and national authorities, patient
representatives and health insurance companies.

SaxoCell Bio
SaxoCell CLINICS supports the development and coordination of an ATMP-based patient registry
and its associated biobank, which derives samples from ATMP studies carried out in the cluster
framework.

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