When an international CRO asked Keats to assist them in a landmark 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 quickly identified a number of potential problem areas and devised a strategy to resolve them:

• Securing a manufacturer with the capacity to produce the large number of comparator drugs required
• Regulatory issues regarding international quality assurance, labelling and legislative differences would all need to be carefully considered and overcome
• Time constraints could delay our client from getting their product into the market
• Coordinating the global, simultaneous delivery of a huge number of comparator drugs, ensuring they all arrived on time and in perfect condition

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