Less rush means less risk

Clinical Supplies is about delivering drugs to patients who participate in clinical trials.  They are part of the critical stage in the development of a new drug that comes after the basic research and before product launch.

This phase involves the manufacture and supply to clinical trials of small quantities of pills - placebos as well as experimental drugs with differing active strengths.  These supplies have an absolute need for 100% control in order to ensure their validity.  The single most important task for Clinical Supplies is to make sure the right patient gets the right pills at the right time.

Since October 2000, a WCI team has been working with Bayer's Clinical Supplies (CS) department in Leverkusen in Germany.  The number of clinical trials Bayer conducts is growing and its CS workload has been growing rapidly - up 300% in three years - as a result of the increased demand from authorities such as the US Food and Drug Administration (FDA) for more clinical studies.  This has stretched the ability of the CS department to consistently deliver a reliable service to its customers.

Clinical supplies is not simply a manufacturing and warehousing operation.  It is a highly complex environment in which there are strict regulatory requirements - different for each country - data which are specific to individual patients, and an overall lack of standardisation.

Most clinical trials involve between five and ten study centres in eight to ten countries.  In total, Leverkusen supplies study sites in twenty five countries from Mexico to the Baltic states.  Each product/pack needs to be labeled in the local language according to local regulations following local approval procedures.

The complexity of the manufacturing operation has also increased and the relatively small CS team (of fifty five people) has been governed by more than 400 Standard Operating Procedures - which operators have found increasingly difficult to follow.

As pressure on them builds up, the risk of making mistakes increases, compromising customer service and endangering compliance.

The WCI project began with an initial audit of the operation, followed by a detailed process analysis and the design of recommended solutions.  The final implementation phase is scheduled to finish in late 2001.

The process redesign has included making far greater use of existing CS expertise.  Currently, it's the physicians and statisticians of the clinical trials teams who define everything allied to the trial - from hiring the participating doctors to data collection and analysis.  Their remit has also included - as a low priority - pill manufacture, packaging design and country specific labelling.

This has often meant that information was passed to CS at a late stage of trial development and that in the Clinical Supplies field, each trial saw a reinvention of the wheel.  However, earlier sharing of know-how would result in a more operational trial set up which will benefit the clinical trials teams and Clinical Supplies.

Standardisation is possible, even in such an exacting field, because the pills supplied will be the same whether the trial is in Lisbon or Warsaw.  Everything can be produced and packaged in advance and warehoused until the order comes.  Only at that late stage is it necessary to add the labels which customise the packs for specific physicians in specific study centres.  Less rush means less risk.  For Clinical Supplies there is an increased compliance due to better capacity planning and new operator-friendly documentation.  And, for the clinical trial teams, process standardisation has reduced to a minimum the effort required in setting up the trial supplies.