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Complex Pack Assembly - Clinical Trials

The next 12 months are likely to see some fundamental development in the clinical trials process with the introduction of new EC legislation and a range of new pack innovations. But despite these changes, the fundamental key to success in any clinical trial will remain the strength of partnership between sponsor and packaging supplier.

In an ideal world, the date for a clinical trial would only be set when the schedule for pack production and distribution had been agreed between sponsor and packaging supplier. In reality however, the scope of a clinical trial can be vast, with some complex studies enrolling thousands of patients in several countries around the world. Therefore, it is understandable that in practice, patients are the priority for the sponsor and the packaging process has to fit in with pre-set targets and time scales. For this reason it is vital that the sponsor involves their packaging supplier as early as is possible within the trial process and that the two develop strong lines of communication and understanding. Clinical trials are by their nature unpredictable and having a reliable supplier on board early within the process will enable a flexible and effective solution to be found.


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By Pat Hobbs, Clinical Trials Technical Manager at Brecon Pharmaceuticals Ltd

Pat Hobbs is Clinical Trials Technical Manager at Brecon Pharmaceuticals Ltd. She has 26 years' experience in the pharmaceutical industry, and for the last 11 years has been involved in the quality assurance of investigational medicinal products.

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