Clinical Trial Pharmacy
The Clinical Trial Pharmacy unit of the UMC Utrecht annually supports over 250 clinical trials that involve investigational medicinal products (IMPs). We have wide experience with various types of IMPs, such as classical ‘small molecule’ drugs, but also advanced therapeutics, such as biologicals and cellular therapy. Our dedicated team is fully GCP certified and our pharmacy is GMP licensed for the production of IMPs.
What we have to offer
IMP handling and storage, Randomisation and unblinding, Support monitor visits and audits, Preparation of IMPs, Therapeutic drug monitoring
IMP handling and storage
We store IMPs at standardised conditions in our Pharmacy according to GCP guidelines. Temperature monitoring is fully automised (24/7) and is periodically calibrated to ensure adequate monitoring.
Randomisation and unblinding
We can help researchers with randomisation (e.g. block randomisation and minimisation) and have a dedicated storage area for randomisation codes. In case of emergency, we have a 24/7 unblinding service available.
Support monitor visits and audits
We have a wide experience with supporting monitors and researchers during their visits and audits. Please contact our team to plan your monitor visit or audit.
Preparation of IMPs
Our pharmacy is GMP licensed for the preparation of IMPs (including ATMPs). We can therefore support your trial with the production of new IMPs and also have the ability to package and label your IMPs according to GCP / GMP Annex 13.
Therapeutic drug monitoring
We have a large and comprehensive laboratory
(CCKL accredited) at our Pharmacy to support your study with therapeutic drug monitoring. A large library of validated tests is already available at our site (Farmalab) and we also have experience in setting up novel drug tests for clinical trial purposes. We can help researchers with bioanalysis and have the skills and knowledge support with pharmacokinetic(-pharmacodynamic) analysis on request.