Penn helps US biopharm company to conduct trials in Germany

Penn worked recently with a US-based biopharmaceutical company that specialises in the oral delivery of therapeutic macromolecules and other compounds that are not currently deliverable by oral means.

Recent advancements made by the company on an orally delivered treatment for diabetes had led to a number of clinical trials being set up across Europe. The majority of these trials were facilitated without any problems, although in the case of Germany, they were dealing with a country that had already adopted the regulations imposed by the new EU Clinical Trial Directive a full 12 months ahead of the target date of 1 May, 2004.

After appraising the situation, the client contacted Penn Pharmaceutical Services, and Margaret Beveridge, business development manager at Penn, remembers the initial enquiry: 'The call came through late on Thursday evening British time and it became apparent that the client was planning trials in Germany, which needed to comply with the new regulations on materials. As set down in the new Directive, they required the services of a Qualified Person to release the materials for trial as well as advice on the new labelling procedures.'

On Monday of the following week, Paul Thomas, one of three QPs at Penn and head of quality and analytical services, travelled to visit the client's facility in the US. He undertook a full review of the premises and procedures that had been followed in the preparation of the materials and completed the necessary paperwork to enable them to meet the requirements of the new Directive.

In order to comply with Annex 13 of the Directive, the clinical trials also needed to meet a number of labelling criteria. Penn Pharmaceuticals Services worked with the client to complete the documentation and relabelling process in a period of approximately two weeks, enabling the study to commence on time and with no disruption to the clinical programme timelines.