A Solution Based Approach to Solve the Challenge of Comparator Procurement
A leading pharmaceutical company approached Fisher Clinical Services to assist them with obtaining comparator study medication for a global Phase III program. The trial was focused on an infectious disease and would involve 25 countries across 130 investigator sites.
In a previous program, the Sponsor had sourced comparator medication directly from the manufacturer, but as all sourcing was done via a central office the price for the study medication in Europe was expensive.
The Challenge The challenge for the Fisher Clinical Services team was to investigate whether it would be possible to source the comparator via alternative countries for use in European sites. Additional challenges included the high price of the comparator drug and the agressive timelines of the study.
Center of Excellence The Fisher Clinical Services Comparator Center of Excellence, based in Basel, is dedicated to sourcing comparator medication globally. With a strong network of colleagues in Western and Eastern Europe, North America, Latin America and Asia, the Comparator Center of Excellence team is able to tap into the global distribution and regulatory expertise from our fully owned resource network around the world. These resources have become critical assets when helping explore the opportunity or need to support supplying comparator and other study medication through or in emerging regions.
The approach The Fisher Clinical Services team first investigated whether or not it was possible to obtain the drug from any of the lower cost EU markets. The team then researched the US market. Initial research revealed that the product was available in the US, and at a cheaper price, approximately 15% lower than the price at which it was currently offered in Europe. Further research was conducted to verify if the product could be purchased and imported into the EU for further blinding and packaging. However, subsequent research revealed that the US version differed slightly in terms of its dilution and preparation. In addition, there was an additional hurdle to overcome – the importation and the Qualified Person (QP) release within the EU as the US had no MRA with the EU at the time.
A parallel sourcing approach In an effort to adhere to optimistic timelines, the Fisher Clinical Services team also investigated the availability of the comparator medication in emerging markets, including India and Turkey. The product was available in both countries – the US formulation in Turkey and the EU formulation in India. The team proactively obtained pictures and supporting documentation including a Certificate of Authorization (CoA) that specified that the product was actually manufactured in the EU under GMP conditions. The resulting approval became a great benefit as it provided the ability to re-import the product for clinical trials within the EU. The team defined a set of detailed procedures which included analytical testing and which adhered to the Sponsors Quality Assurance (QA) procedures.
End-to-end solution This cold chain comparator medication put additional demands on the Fisher Clinical Services team. It was essential to manage the transportation and handling of the product carefully, including selecting the proper shipping containers and transportation method to avoid any product contamination or loss due to temperature excursions. The Fisher Clinical Services team was able to co-ordinate the entire procurement, transportation, receipt and packaging for the Sponsor from beginning to end, meeting the Sponsor’s deadlines and reducing the original estimated budget by 20%. Fisher Clinical Services continues to source comparator for this Sponsor.