Always have a Plan B
A European pharmaceutical company that had been a customer for some time contacted ADAllen Pharma at the end of July to source comparators for a multi-country clinical trial. Initially the specification was for US and various European formulations of a marketed drug.
Problem importing an EU manufactured product
During August we worked with the customer to develop alternatives and agreed a “Plan B”, which was to find supplies of the drug meeting the specifications in three European countries and a Middle East country. Although we found some formulations that met the specification, no tablet existed that was suitable in all the markets. We had also encountered a potential problem with importing an EU manufactured product into two of the trial countries.
Obtaining import licences
Our project manager worked with the customer to provide information to the regulatory authorities in those countries, and eventually the customer was able to obtain import licences. We then clarified details about the tablet’s size and coating so that the planned over-encapsulation would not compromise its dissolution and hence its metabolism.
At the start of October, and after a considerable amount of detailed research, our customer was able to place an order for the full trial quantity.
Sourcing comparators for clinical trials
If your company needs assistance in sourcing comparators for clinical trial, contact ADAllen Pharma to discuss your requirements in more depth.