SLB Pharma offers to manage your clinical project, either in its entirety or in part, and provides a full range of services on request.
Our team carries out each stage of your project in accordance with good clinical practice and the regulations in force:
Methodological expertise: assistance with the choice of research classification, calculation of the number of required subjects, writing of the statistical analysis plan.
Design and drafting of the study documents: protocol, investigator brochure, inform consent form, case report forms (paper or electronic format).
Regulatory submissions: ANSM (French National Agency for Medicines and Health Products Safety), CPP (French Ethics Committee), CCTIRS (Advisory Committee on Information Processing in Material Research in the Field of Health), CNIL (French Data Protection Authority).
Feasibility and targeted selection from among the centres most suited to your project in terms of scientific reputation, recruitment potential and structural capabilities.
Negotiation of additional clinical costs and drafting of financial agreements.
Coordination, monitoring and management of the trial: management of the centres, management and optimisation of recruitment, pharmacovigilance / medical device vigilance / nutrivigilance.
Monitoring of the centres: on-site and/ or remote monitoring, monitoring report.
Data management & statistics: data processing, statistical analysis, statistical report.
Medical writting
Assistance with the writing of your communications materials.
Would you like to receive a quote? Would you like some more information? Please get in touch with us by completing this form.
