The comments follow the publication of the firms’ survey of CROs, CMOs and pharmas, which revealed a significant level of dissatisfaction with current supplies forecasting and the technologies supporting the clinical trial process.
BioClinica spokesman Bob Troeller told Outsourcing-pharma.com that, according to the study, few contractors use forecasting and simulation systems and those that do use platforms that are ‘glorified Excel spreadsheets.’
“It also seems most pharma companies only use spreadsheets or just guess based on past performance expectations.”
This was echoed by Paragon’s director of life sciences clinical optimization James O’Keefe who told Outsourcing-pharma.com that: “Simulation is definitely a new area, and still not well established in the marketplace for Clinical Supplies.
“Forecasting, in one method or another, does occur, but with limited success for optimization of the clinical supply chain.”
Troeller and O’Keefe agreed on the root causes of the shortcoming, citing change management, evolving roles and job functions and a reluctance to embrace new software and technologies as the key factors.
“Clinical Supplies teams are charged with ensuring drug is available where and when it is needed, but not necessarily charged with doing that efficiently. Thus, so many respondents rely on over-supply as a primary approach,” said O’Keefe.
Troeller concurred, added that the approach is rife with inefficiency and suggesting that overproduction of trial supplies based on such estimates can add $1m to the cost of a Phase III study.
“It’s not just about wasted drug; in some instances a company might forecast a certain amount of supply at sites all over the world and after running multiple scenarios, they come to find out there wasn’t going to be enough packaged so they’d lose a bunch of patients who would show up at a site but there’d be no drug for them to randomize to.”