EXCLUSIVE: Un-CTMS tracks trials and reforecasts

When is a clinical trial management system not a CTMS? When it's clinical trial operations (CTO) software for planning, forecasting, outsourcing and project tracking. And it harmonizes operations across clinical planning, outsourcing, finance and outside stakeholders.

ClearTrial is unveiling such a system today, version 3.0 of its CTO software. This version includes new software called Track, the third component in what many consider a clinical trial management system despite the company's protestations.

"Don't categorize it as a CTMS," says Mike Soenen, ClearTrial CEO, during a pre-release product demo last week. "It works with a CTMS or it can stand alone. It alleviates the pains associated with CTMS systems." Among those pains: the costs to buy and implement such systems, the data entry required, and the subsequent outdated data.

Soenen contends now, as he did in a FierceBiotech IT Op-ed Corner last May, that the clinical trail battlefield has changed, given the prevalence of electronic data capture and interactive voice response systems, as well as the far greater use of outsourcing. Using existing CTMS technology, he says, is like fighting the last clinical trial war; the technology is insufficient for today's fight.

The Track software was preceded by Plan, the core software component of the product suite. Plan provides operations planning for business goals in addition to what-if scenario planning. It provides assumption-driven study budgets, key metric and milestone data forecasts, and fixed unit price schedules.

The Plan software feeds Source, which helps streamline the outsourcing process. Its emphasis is contracts--closure time, negotiation leverage and change orders. It also aids in the forecast of accruals for outsourced projects.

The new Track software encompasses project tracking, management of accrued liabilities, and re-forecasting for change orders and midstream study adjustments. It is accompanied in v3.0 with integration of the three software components. The result is what ClearTrial calls an integrated management platform for clinical trial planning, forecasting, outsourcing, and project and financial tracking. But not a CTMS.

Track also aids in earned value management, what Soenen calls "the science of knowing where I am on my project from both schedule and cost perspectives." He says that without automation, earned value management can be intimidating. But the advance visibility lets project managers see where they will end up if they don't make course corrections. "It lets them be more proactive and act more quickly," Soenen says.

- here's today's announcement