- Services
- GMP services
- Submitting a new clinical trial
- Submitting documents for ongoing studies
- Make an appointment
- Video
Services
The Pharmacy clinical trials team of the hospital pharmacy offers all services for the management of medicines and implants in a clinical trial. This applies to all phases of research, both for academic and sponsored studies. In the brand-new cleanroom, our pharmacy staff prepare sterile medicines for clinical studies in accordance with the strictest quality requirements.
- Receipt: conformity check and receipt registration
- Storage: under correct storage conditions (room temperature: 15-25°C, cool: 2-8°C, -25°C, -80°C) and continuous temperature control
- Preparation:
- immunotherapy, cytostatics, GMO, sterile
- single and multiple dispensing
- Repackaging, randomisation, relabeling, labeling with Annex 6 label
- Distribution
- Return to sponsor or destruction of (un)used medicines
- Accountability
- Archiving of study files
GMP services
Our team also has a cleanroom for the production of non-sterile medicinal products in the research phase for which a GMP licence is required. Research institutions and pharmaceutical companies can call on our services in this context.
- Support in drawing up the study design
- Production of non-sterile hard capsules and liquids for internal and external use
- Import (batch certification) of non-sterile and sterile medicines for research
- Drawing up an IMPD
- Protocol for preparation, repackaging (including composition of patient-specific kits), randomisation, relabelling, labelling with Annex 6 label
- Temperature-controlled (15-25 °C, 2-8 °C and -20 °C) storage in GMP warehouse
- Temperature-controlled GDP transport from IMP to other sites in Belgium and abroad
- Return to sponsor or destruction of (un)used investigational drugs
- Archiving of study files, reference samples and production samples
Submitting a new clinical trial
As a pharmaceutical company, have you scheduled an appointment for an initiation? Then you must register the clinical study in advance using our registration form for new clinical studies.
Submitting documents for ongoing studies
Use the notification form for new study documents for:
- new or amended study documents
- permanent CRA transitions
- requests for additional access to the protocol site
Make an appointment
- Would you like to make an appointment as a pharmaceutical company for a selection, initiation, monitoring or close-out visit? You can do so via the online appointment portal.
- Appointments for audits or inspections can only be made via pharmacy.clinicaltrials@uzgent.be.
Patients cannot contact us to participate in a clinical study. It is best for them to discuss this with their treating physician.
Video
See how we are taking clinical trials to the next level in the video.