We are able to provide full benefits for clinical research, ranging from the writting of development plan taking into account the budgetary and time constraints of our client, through the drafting of all documents of the studies, regulatory submissions (France and Europe), the selection of investigators, monitoring and data management, coordination of the project and its stakeholders as a whole.
We can promote clinical studies of our customers, building on our own SOPs (designed in collaboration with major pharmaceutical companies) or on the SOPs of our client.
It is thanks to a multi-skilled and experienced team that we are able to offer our customers full benefits in clinical research from phase I to IV.
Project development :
- Elaboration of clinical development plan and a budgetary estimation
- Selection of subcontractors (therapeutic units manufacturers, printers, central lab, insurance broker, shipment company...)
- Protocol, study documents (ICF, IB) and CRF development
- Regulatory submissions in France and Europe : Ethics committee, Competent authority...
- Selection of sites and investigators
- Site initiation visits
- Monitoring visits and data quality control
- Site close out visits
- Data management/Statistical analysis
- Clinical study report writing
Ensuring of timelines and critical points
Follow-up of study progression (regular update of tracking tools)
Communication: organization of meetings, newsletters, contact with investigators and sponsor
Management of IMP
Management of subcontractors (therapeutic units manufacturers, printers, central lab, broker, shipment...)
Management of SAE
Administrative management of sites: CDA, investigators contracts, biomedical research contracts, fees...
Preparation and regular update of TMF
Qualissima executes all services within the framework of a Quality System intended to ensure customers an optimal results in fulfilling their needs.