Services

CRO & SMO

With the aim of satisfying best its customers, Qualissima offers a full range of clinical trials services.

Indeed, its leans on its staff with multiple skills to execute any clinical study from phase I to IV.

Project development :

•    Elaboration of a personalized project and a budgetary estimation
•    Requirement definition and contract negociation
•    Protocol and CRF development
•    Regulatory strategy : Ethic committee, Competent authority

Project management:

•    Dashboard implementation
•    Study progress follow-up
•    On-line progress status through the Professional Area
•    Meeting organization
•    Pharmacovigilance

Study execution:

•    Selection of investigator
•    Selection of sites
•    IMP management
•    Monitoring and audits
•    Data management/Statistical analysis
•    Writing of clinical report

Qualissima can also be in charge of clinical studies sponsoring, by leaning as well on its own SOPs as on those of its customers if necessary.

Qualissima executes all services within the framework of a Quality System intended to ensure customers an optimal results in fulfilling their needs.

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