Keats Healthcare Ltd.

When an international clinical trials organisation approached Keats Healthcare Ltd to assist them in a massive global trial requiring a product that was unavailable in all the required criteria it was necessary for us to combine a number of our proficiencies to successfully deliver comparators to our client.

Our team worked to swiftly identify a number of potential problem areas:

• Securing a manufacturer with the capacity to produce the large number of comparator drugs required for the trial
• Regulatory issues regarding international quality assurance, labelling and legislative differences which would all need to be carefully considered and overcome
• Time constraints. The sooner the study could begin, the closer our client would be to getting their product to the market
• Co-ordinating the global, simultaneous delivery of a huge number of comparator drugs, ensuring they all arrive on time and in perfect condition

Following negotiations we were able to secure the services of a large, global manufacturer offering our customer value for money as well as capacity. Simultaneously our team was working to satisfy regulatory requirements, designing unique, integrated labelling appropriate for all trial countries and securing C of A and QP release services to streamline the transition from manufacture to distribution.

As a result, once the product was delivered to our warehouse and quality control was completed, we were able to re-distribute the product swiftly with the appropriate documentation and clearances. This ensured that the clinical trial was able to go ahead on time, in all locations; thus emphasising Keats' values of providing our clients with a fast, flexible and innovative service.