Northwick Park Hospital, part of the North West London Hospitals NHS Trust is relying on the Ultimate labelling solution from Episys, the global information technology solutions and services company, to manage the labelling on all drugs used for clinical trials, and in so doing, cut management time and control errors.
Theo Emmanuel, Senior Clinical Trials Pharmacist at Northwick Park Hospital, said, "We have been a customer of Episys for a while now and are using the system to assist us with the printing of labels for all the clinical trials we run here at Northwick Park. We have also recently started using the system to print labels for work carried out under our MIA (IMP) Licence. The ability to design labels that meet the correct regulation requirements is key to us and any clinical trial service. The labels are easy to design and we have much more freedom in terms of what we want to include on the label. The system provides us with a blank canvas."
Theo continued, "What's great about the Episys system is that is allows us to ensure that labels comply with the high standards set by the MHRA. From a manufacturing perspective a trial can involve thousands of IMP doses so printing labels used to be costly and designing labels time consuming. Ultimate saves us time, helps us to keep errors down and helps save money on re-prints. The old system was not fully controlled and was open to mistakes. We are very happy with the system and in the future may look to add colour and barcodes to our labels, something the system can also manage."
The Ultimate software generates the clinical trial databases used to define the relationship between patients and treatments and includes a filter system that allows selected subsets of the clinical trial database to be copied to separate database tables. The system creates a new 'trial' based on a name supplied by the user. Information on the trial can be entered including the drug name and dosage for each drug, and the centre and number of patients for each trial centre. Additional information can then be inputted including the trial type, trial balancing, base patient number, number of visits per drug, whether to keep the patient sequence across centres and the blocking multiplier.
Derek Buchanan, Chief Executive Officer at Episys, said, "The success or otherwise of a drug trial depends heavily on accuracy of the labelling and distribution of component drugs and then the data that results from it. Ultimate is simply there to make the process accurate, quick and error-free."