In recent years there has been a dramatic change in the size and nature of clinical trials, it is now commonplace for companies to run massive global studies conducted in perhaps 30 countries having many thousands of patients and many hundreds of investigator sites.
It is also commonplace for the clinical supplies to be sent ajustin-time' to the various investigator sites, this in turn has caused a rapid re-engineering of how clinical supplies are produced both in-house and also by contract suppliers.
In the previous edition of Elab magazine Clinical Trial Services (CTS) wrote an article detailing our new automated system for the labelling, verification and compilation of clinical trial supplies. This new system is known as Transmark and was designed, built and validated within an eight month timeframe, this technology has enabled us to massively reduce the time to label and compile clinical supplies for global studies.
However, a further problem still exists with regard to just-in-time distribution to the various investigator sites. A large global phase III study can involve many thousands of just-in-time shipments to the various investigator sites throughout the world, with the vast majority of distribution requests being received electronically via interactive voice response systems (IVRS). This requires having a dedicated distribution department that is totally familiar with all global import requirements, it is also essential that the distribution department know the exact location of the supplies required for a particular shipment.
In order to speed up the picking of the correct supplies CTS has now developed a bar coding system used throughout our distribution process, the system will identify the exact location within the distribution warehouse of a particular clinical supply pack. Each pack will incorporate a unique barcode, by scanning both the barcode on the supplies and the barcode of the location in the distribution warehouse the exact location of each supply is thereby controlled on our central distribution system. This system in turn will eliminate many of the visual checks which have to be carried out in order to guarantee the integrity of each shipment and in turn will dramatically reduce the time taken to despatch clinical supplies. u
ENQUIRY No 16
Clinical Trial Services is based Craigavon, Co. Armagh, Northern Ireland. www.cts-global.com
