The transparency trial

As the clinical trial process continues its reign under the microscope of scrutiny, companies are starting to realise the true power of transparency – a weapon that can

The pharmaceutical industry is under increasing pressure to improve the productivity of drug development and streamline the clinical trial process. From your perspective, how can this be achieved?

Leslie Morgan: The industry is under huge pressure to reduce costs. In my particular field of expertise the sourcing of comparators, ancillaries and standard-of-care medications we are continently innovating to reduce costs. Let me cite some examples - purchasing from one country for the entire global supply thus using the differential pricing between countries to deliver a real cost reduction for our client. We have also worked directly with the manufacturer to produce special batches just for our client. This ensured the reliability of the supply for the trial. 

By working in partnership with the trial sponsors and becoming part of the planning process, we can structure the sourcing and procurement of the comparators, standard of care drugs in a way that is most cost effective. In essence it's about working with experts and getting them involved as soon as possible so that you use their expertise to help you reduce costs.

How important is transparent pricing in clinical trial supply?

LM: Let me first define transparent pricing as it can mean many different things. We believe transparent pricing is being absolutely open about our procurement costs and our selling costs. We actually go as far as providing documentary proof of purchase price.

We believe this is vitally important for a number of reasons and offer it to all our clients. The procurement of comparator products can be a complex operation with possibly packing houses, CROs and specialist procurement companies all involved. Only with transparent pricing can the sponsor be assured that they are achieving the best possible value. However transparent pricing is not just about cost. It also ensures the pedigree of the product which is vitally important with the increase in fraudulent pharmaceuticals on the market. With transparent pricing the sponsor obtains full clarity of where the drugs have been purchased and what profit margins the supplier is making. It's really about true partnership between the sponsor and the service provider. Certainly our clients are welcoming this approach.

What should pharmaceutical companies look for when choosing a clinical trial supply partner?

LM: Overall it has to be one that the pharmaceutical company can trust and have confidence in to carry out the work to the required specification. In our field of comparator and standard-of-care medication supply this means they have to have a global reach for sourcing and procurement covering not just the USA and EU but also the emerging research areas such as Russia, the Far East and Latin America. I think it is important to choose a supplier who has a history and experience of dealing with these countries, which will generally mean that you need to choose a larger, more diverse supplier.

Also vital is the transport capability of the supplier - can they get the product to where you need it on time and in the right condition?

These however are the 'front office' capabilities.  They obviously need to be back up by the general infrastructure of the company with full Quality Management, appropriate technical and professional support including Pharmacovigalence, in-house pharmacists and Responsible Persons. A properly resourced and licensed warehouse with the capability to handle both ambient, cold chain and controlled drugs is also vital.  In summary it's about trust and as I have said before transparency in all dealings not just in pricing is the best way to demonstrate and build this.

About

Leslie Morgan is a qualified Pharmacist, owner and Managing Director of Durbin PLC, the leading specialist supplier of Pharmaceuticals. Durbin has divisions operating in clinical trials Supply, International Distribution, Family Planning Supply, Charity Supply, Unlicensed Medicines and Early Access Programmes. He has recently been appointed a Visiting Fellow at the Cass Business School, City University London.