| With the clinical trial market requiring sophisticated supply methods, Jonathan Gorman at Almac Group charts the complexity of moving a box from A to B
The fact that the clinical trials logistics market is changing is well- documented. It is crucial that clinical supplies are available at investigator sites when needed to ensure the success of any investigative trial. Increasing globalisation and the push into emerging markets offers pharma companies significant benefits but also present considerable logistical challenges. One of the basic tenets of modern supply chain management is to reduce the number of parties involved. To this end, pharma and biotech companies require vendors who can offer a complete approach to the challenges of modern global clinical trials logistical operations. In other words, they want to outsource to vendors who can offer a full suite of complementary services, ultimately reducing costs, timeframes and vendor management while improving the quality of the overall supply chain (1).
The obvious benefit of the reduction of the number of vendors is less sponsor company time dedicated to supplier management; a significant proportion of issues can be handled in-house by the vendor where, previously, intervention by the client would have been necessary. This has the effect of alleviating pressure on both the outsourcing and clinical teams of the client organisation, allowing them to focus resources on core activities such as protocol design, regulatory processes and patient recruitment.
Difficulty in patient recruitment in ‘traditional’ markets has resulted in the increasing use of emerging markets – CEE (Central and Eastern European) countries initially, but increasingly even more distant territories such as Asia and Latin America (2).
THE DISTRIBUTION PROVIDER
A clinical supply organisation’s operation in this environment must be truly ‘global’. They must have an established global strategy to facilitate the distribution of clinical trial materials. The importation of clinical supply materials is highly regulated and compliance with country-specific regulations is vital: a lack of compliance can lead to significant delays. |
