Biokinetica pharmacy (area & equipment located within each site) is dedicated for drug preparation and storage as well as for repackaging, labelling and blinding of the IMP. All procedures within the pharmacy are covered by our qualified pharmacy team (three certified pharmacists).
- Secure pharmacy room with controlled access
- Centralized, alarmed system for temperature & humidity monitoring and control
- All required storage conditions available (room temperature, +4o, -20o and -80oC)
- Repackaging, labelling and randomization of the IMP
- Pharmacy premises with limited access & controlled conditions
- Computerized IMP management system
- Dedicated room & equipment for IMP preparation (laminar chamber)
- Procedures performed accordance with the GMP guidelines
Clinical supplies are handled and stored according to the Sponsor’s instructions, the clinical study protocol and local law. There are sample drug storage capabilities in the internal and hospital pharmacy.