Research Pharmacy

The CRF contains an onsite dispensing pharmacy and aseptic compounding unit which can prepare individually tailored medicinal products such as gene therapy agents for clinical trial patients. The unit is staffed by qualified and trained pharmacists.

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 Institution, 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:

1. Dispensing of oral and injectable Investigational Medicinal Products

We dispense oral and injectable investigational medicinal products (IMPs) and auxiliary medicinal products (AxMPs) 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 a -80oC freezer for storage of IMPs.

2. Advanced Therapeutics and Gene Therapies

We are experienced in the storage and preparation of gene therapy products and have developed a suite of procedures for handling ATMPs.

3. Aseptic Compounding Unit

We have a dedicated aseptic compounding unit and the ability to prepare a variety of different products including advanced therapy investigational medicinal products e.g gene therapy products.

The aseptic compounding unit is equipped with negatively pressurised pharmaceutical isolators including two hydrogen peroxide gassing isolators. The isolators are located in a Grade B cleanroom.

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.

4. Investigator-Led studies

We provide advice on pharmacy procedures for investigator led clinical trials and work closely with Sponsor and Investigator to facilitate start-up.