Our dedicated clinical trials pharmacists are highly skilled and manage a diverse range of clinical trials from Phase I to Phase III. Our pharmacy works in close partnership with the main St James’s hospital pharmacy.
The role of our pharmacy in relation to clinical research is to safeguard subjects, healthcare professionals and the Healthcare Provider Organisation (HPO), by ensuring investigational medicines are appropriate for use and are procured, handled, stored and used safely and correctly.
Our CRF clinical trials pharmacy can provide the following services:
We dispense oral investigational medicinal products (IMPs) and injectables for Phase I to Phase IV clinical trials. Our pharmacy room is temperature mapped and alarmed to ensure all IMPs are stored correctly. We have temperature alarmed fridges and -80C freezers for storage of IMPs.
We have a dedicated on site Advanced Therapeutics room which has been used for the compounding of gene therapy products. We are the only site in Ireland that has the expertise and capacity to deliver highly complicated gene therapy clinical trials.
We have the ability to manufacture individually tailored gene therapies or advanced therapeutic preparations for St James’s Hospital clinical trial patients. The ATIMP room is equipped with modern isolator technology in a cleanroom environment. The cleanroom operates as a Grade C (European G.M.P.) environment whilst the aseptic filling and preparation are carried out within either negative or positive (Grade A environment) isolators. A comprehensive validation programme for staff and equipment is in place, according to international guidelines. The unit is staffed by qualified and trained pharmacists and technicians and works closely with the main St James’s hospital pharmacy.