10
Of successful experience
Clinical trials Services
Services offered include:
01
Clinic study protocol
02
Investigational brochure (IB)
03
Clinical study Reports (CSR)
04
Patient Profiles for Different Phases
05
Clinical trial authorizations (Incl. IND applications, IMPD (Investigational Medicinal Product Dossier) production & EC/IRB approvals
06
Paediatric Medicines Development (PIP (Paediatric investigational plan) and PUMA (paediatric-use marketing authorisations)
07
Informed Consent Form (ICF) and participant information sheet development