We have an actual scoop. As an old magazine guy on a bimonthly schedule, we had almost forgotten how to handle the situation. We were forced to duck into our local public library and consult one of those dusty journalism texts.

It seems that at the ExL Clinical Supply Forecasting Summit, to be held next week in Philadelphia, there will be an announcement of an intriguing new partnership. It heralds even greater prominence for adaptive trials, with a new tool that addresses a big gap in the industry’s toolbox for taking advantage of the promise of adaptive approaches.

Cytel and Tourtellotte Consulting have integrated two pieces of software. This will allow sponsors to add drug supply forecasting to the statistical software that powers adaptive trials. In simple terms, the companies say they are forging a connection between the statistical and operational components of an adaptive trial, tying a protocol and the manufacturing process a bit more closely together than has been possible in the past.

Adaptive clinical trials, in which data from a trial are factored back into the execution of the trial itself, pose extreme logistical and technological challenges for a paper-addicted industry such as the life sciences. The prospect of a tighter linkage between advanced biostatistical software (the specialty of Cytel) and drug supply simulations (the specialty of Tourtellotte Consulting) could ease the minds of sponsors contemplating adaptive designs.

Randomization Engine

The Cytel software is a randomization engine that works in all phases of research. It’s called FlexRandomizer. The Tourtellotte product, tcVisualize, simulates drug supply needs according to a wide ranging number of variables, and is called tcVisualize.

“In merging clinical supply chain simulation with flexible randomization, this joint application finally allows drug and device development companies to gain the savings, both in time and cost, offered by adaptive trials. Companies will be confident that a large range of scenarios has been simulated to minimize the chance of unforeseen glitches,” said Ranganath Nayak, chief executive officer of Cytel.

‘Take That Barrier Away’

“Adaptive trials provide some serious efficiencies in Phase II and Phase III,” says Ed Tourtellotte, president of Tourtellotte consulting. “A major barrier for adopting adaptive trials is that the supply picture is so murky. No one can figure it out. We’re going to take that barrier away.”

The combined products are working together now and available to customers. The integration is so freshly completed that customers have not yet tested it. “We’ve really raced to get this done for the ExL Pharma Summit,” Tourtellotte says. “It’s the perfect summit for us.”

Both companies are trying to link their technology with prominent allies.

Tourtellotte Consulting recently joined the Oracle PartnerNetwork. This website recently wrote about Tourtellotte and Parexel partnering.

Last year, Cytel’s FlexRandomizer was added to the interactive voice response (IVR) system from the Brussels-based International Drug Development Institute. Cytel’s technology has also been combined with Medidata’s EDC package, Rave. Here’s a white paper explaining that effort.