Advisory services
1 Nov 2016
- translating pre-clinical findings into the development of therapeutic strategies for humans
- Strategic partnerships with several phase-I units, in particular with the 'Centre for Human Drug Research' (CHDR)
- Constitute 'Executive Committees' and/or 'DSMB'
- Transition of phase I, into II, III or IV:
- Protocol preparation and review
- Project planning
- Development and review of the eCRF
- Development and/or review of the 'Patient Information File' (PIF)
- Review of the 'Clinical Study Report' (CSR)
- Manuscript preparation