A while back, we wrote about the need to rethink the seat-of-the-pants school of managing drug supplies in this article. Since then, Tourtellotte Consulting has partnered to integrate its application with the interactive voice response system (IVRS) from the Perceptive Informatics division of Parexel.

The idea? To make sure the IVRS and drug supplies are not just in sync, but allow more accurate forecasting and the right level of drug over-supply.

Here’s a quote from the release: “Accurate supply chain predictions are essential in clinical trials as drug shortages or delays can have a significant impact on study outcomes. We believe clients will be able to gain more control over their supply chain while improving the quality, efficiency and cost-effectiveness of their clinical trials with this new solution,” said Todd Joron, corporate VP and general manager, Perceptive Informatics.

Learning From Others

Jean-Remy Behaeghel is the director of product management at Perceptive. He pointed out that most large industrial companies have IT systems to handle supply chains. The life sciences, he suspects, could do well to study what other industries have already accomplished. “WalMart and Home Depot have those issues on a daily basis,” he says.

Perceptive and Parexel, he said, are used to shipping drug supplies all over the world. But Latin America is a particularly complex arena of customs and logistics, and one in which his company has especially deep experience. Shipping drug from one country to another can be more complicated than you think in Latin America,” Behaeghel says.

Worst-case Scenario

Beyond the paper work associated with shipments, he notes that there are educational issues inside many companies. “One of the myths you have to fight with some clinical teams is that there is an infinite amount of supply and it can materialize anywhere in the world at any time,” he jokes.

Depending on the country, there could be delays of days or even weeks in the case of a shipment going from the UK to Russia.

Given the price of drug supplies, Behaeghel says it’s hardly a surprise that clinical teams focus on the overage, or excess. But that’s the wrong notion. Other costs associated with not having drug supply available (study interruptions, say, or patients turned away) could be far higher and more damaging in operational terms.

Look, Ma! No Spreadsheets

Obviously, the industry is well aware of such dramatic but rare events. “To avoid those dramatic incidents that we see once in a while, there is a tremendous amount of energy spent,” he says. Smart companies are trying to figure out if software can judiciously help sponsors minimize the overage to the lowest level that is prudent.

The real issue is how many assumptions and nuances and scenarios can be plugged into an Excel spreadsheet or a good manager’s brain. There’s no question that the shipping nuances of vaccines and biotechnology products, which may require refrigeration, add still another layer of complexity.

Expanding The Team

Incorporating drug supply experts into clinical trial planning is not yet standard throughout the industry, Behaeghel says.

But that is becoming more common, especially if a company has survived a painful lesson in a trial in which supplies were an issue. “Some people are starting to realize the value of considering value earlier in the process,” he says. Real dialogue between all the areas of domain expertise in a trial is a good thing, and should include drug supply experts.

Representatives from clinical, biostatistics, data management, manufacturing and other teams should offer a seat at the table for someone who can talk about supply in a rigorous, quantitative way.

Simulation Engines

Such discussions, in the years to come, will involve not only negotiation but also simulation. (That’s the forte of tcVisualize.)

Various proposed tweaks to a study (What if we change to a regional randomization? What if the expiration dates have just been moved up? What if we eliminate the sites in Venezuela?) will have effects on drug supplies that only a computer can estimate. Each scenario may have both advantages or unexpected consequences. “Some of them can have devastating impacts on the supply chain,” Behaeghel notes. “You can’t assess the questions without doing simulation.”

He doesn’t think that spreadsheets, as common and as beloved as they may be in some companies, are a suitable tool for tackling many of today’s global trials. “I’ve seen trials where the supply person shows up with a spreadsheet, but a spreadsheet is not enough,” he says.

Defining “Overage”?

What’s more, simply talking about overage, he says, “is not the right key performance indicator. How many patients did you lose? What is your total cost? People focus on the average and we believe this is not the right measure to use to measure the efficiency of the supply chain.”

Integrating an IVRS to drug supply simulations can help, obviously, because it can provide information about who’s already been enrolled in the trial. And the tcVisualize application from Tourtellotte Consulting, in turn, is a quantitative, Java-based crystal ball that allows study teams to simulate a variety of decisions about drug supply—and see the likely consequences of those decisions. 

Linking To Other Systems

In some ways, Behaeghel points out, a clinical trial management system can be another useful hub to help with real management of supplies. (He was too polite to mention it, but of course his company does sell a CTMS called Impact.) “The CTMS can give you visibility across more than one trial, across a therapeutic area, the whole company,” Behaeghel says. “That can be the source of the information to use to improve the planning of a trial.”

The industry’s generation of more electronic data from a variety of sources, Behaeghel says, is gradually enabling faster and more savvy decisions about drug supplies.

“People are getting better data to make those decisions. They get real time data of what the actual picture is. You are getting a better sense now with all the business intelligence and reporting. They get better pictures and earlier signals.” That, he says, can make the difference between a disastrous and abrupt halt to enrollment—or a far more benign slowing of recruitment until more supply is available.