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Insight Into Using Labs for Increasing Operational Efficiencies

Posted by Steve Morley, July 02, 2010, 2:35 AM

This past week, I had the opportunity to speak at the Partnering with Central Labs, ECG and Imaging Labs Conference in Brussels, Belgium. I was asked to discuss the above mentioned subject, and also to provide insight into how Sponsors can work with central labs to optimise operational efficiency, yet still deliver the cost savings demanded by the industry. I would like to share with you not only the main points presented at the conference, but also, a selection of the questions that were raised in the discussion afterwards.

In the first part of my presentation, I referenced the Logistics Task Force discussions that were held in San Francisco earlier this year at the Central Labs West meeting. Several themes were evident, which I discussed in more detail during my presentation in Brussels.

Firstly, in dealing with operational logistics, Sponsors require justification of the fees, and are frustrated at the lack of transparency, particularly when it comes to the breakdown of transportation costs which can comprise approximately 50% of the central lab budget. Sponsors also require confidence that the initial central lab proposal is accurate, which can cause challenges. The lab can find themselves in a ‘Catch 22’ scenario: they want to provide realistic and honest costings during the proposal stage so that Sponsors have an accurate assessment of the overall transport budget, yet can lose business to another lab who uses more aggressive and, potentially less realistic assumptions. I posed the question, whether honesty was always the best policy? There are, of course, difficulties with providing realistic costings at the proposal stage when detailed site locations may not yet be known. Variations in budget construction and how transport costs/management fees are broken down, can also make between-bid comparisons difficult. In regards to a possible solution to these challenges, I discussed the idea of creating a Scope of Work (SOW) document once a study has been awarded, to allow accurate budget management throughout the study. Such a SOW will allow a true “baseline” assessment of the sample transportation costs, and ensure that out of scope management and overall budget spend tracking can be monitored.

The second part of my presentation looked at the ‘added value’ central labs can, and do offer, and how Sponsors can tap-in to this expertise to bring operational and financial efficiencies. Central labs have staff employed to track and keep samples moving, and the relationships that these staff develop with couriers allows central labs to deal with the real-time issues that Sponsors don’t always have the in-house resources to manage. To illustrate this point, I used the example of the recent volcanic ash related closures seen across European airspace.

In addition to transportation management, central labs offer analytical expertise. Providing input into protocol design, shipping strategy, assay frequency and subcontractor management, can significantly impact study efficiency and overall cost. The management of investigators must also play a part in reducing costs. By scheduling patient clinics to allow for multiple sample collection and shipping on the same day, and within transport kit sample bundling, courier costs can be reduced. The use of country/region depots for the storage and distribution of blood collection kits can also decrease the number of international shipments, reducing costs and potentially minimising the amount of time to resupply sites.

After the presentation, I received several interesting questions from a very interactive audience. One of the questions raised, was whether sample transportation expertise is provided by the courier rather than the central lab. In response, I was keen to stress that couriers do provide invaluable expertise, as do central labs, and it is important that a 3-way relationship between the Sponsor, courier and central lab is encouraged. This can only enhance operational efficiencies and identify potential cost-savings.

A further question concerned the use of depots to store blood collection kits, and whether that would lead to increase wastage of expired kits. In response, I stated that the volume of kits shipped to depots does need to be managed and reviewed regularly to avoid unnecessary wastage. However, the reduced requirement for individual international shipment will offset this cost. The use of depots has been particularly useful during the recent change in custom regulations in Russia, which caused very significant delays importing kits into the country. Having a stock of kits already in Russia, allowed site distribution to continue without incurring the delays caused by the enhanced customs clearance process.

Do you have any additional enquiries in regards to using depots to store kits, sample transportation expertise and/or operational and logistical efficiencies in reducing transportation costs?

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Thanks and stay tuned.

Category: Logistics