Service aids in trial ops management

A new service from a clinical trial operations software provider offers an assist to biotechs in getting on top of clinical trial processes and costs. It may also serve as a much-needed conversation-starter between life sciences solution vendors and a purchasing public still skeptical of them. ClearTrial's Study Costing & Optimization Service (SCOS) is a turn-key offering that provides small biotechs a window into clinical trial costs, resources, and timelines to aid in trial management.

According to ClearTrial VP Andrew Grygiel in a phone interview, "Smaller biopharma companies lack the visibility to accurately forecast clinical trials, leading to them not understanding how much clinical trials should really cost, as well as dealing with unforeseen shifts in trial timelines."

Pharmaceutical technology analyst Ruchi Mallya of Ovum Health Care Life Sciences, now a part of Datamonitor, sees the service offering as part of a trend among software makers. "Vendors in general are providing more services for generally helping biotech and pharma companies," she says in an interview. "They are becoming part service provider, part CRO, and part consultant," in addition to solutions provider.

Mallya writes in a recent column that "executives and end users remain hesitant to replace manual protocols that have taken years to develop with unfamiliar automation." So the onus is on IT vendors to educate the life sciences industry and help it overcome its skepticism of pharma-specific commercial IT solutions.

In the SCOS offering, clinical services managers from ClearTrial run its trial operations software on behalf of the biotech client. The clinical services managers--all of whom have clinical operations experience at CROs and biopharma companies, and some of whom have medical backgrounds--are experts in clinical development, outsourcing, and project management. They function as an extension of the biotech's internal clinical team, says Grygiel.

The initial goal is for the managers to understand the study's design, objectives, and assumptions. They then use the ClearTrial software and its activity-based planning methodology to generate cost, resource, and timeline reports for multiple study scenarios. The scenarios aid the study team in what-if analyses of cost and time tradeoffs. 

The software includes an inventory of clinical assumptions, says Grygiel, that back up the service's monthly budget estimates and "very quantitative" projections for unit costs, unit hours, timeline projections, cash flows and recommended resource staffing. The projections, in addition to helping the biotech manage trial operations, are also useful in negotiating deals with CROs.

In one of the eight SCOS pilot studies, the client realized "dramatic reductions in study costs and timelines, while ensuring that the studies were still achievable," Grygiel says. The study was a global Phase II trial run by a West Coast biotech. The biotech realized $7 million in savings, he says, based on optimization possibilities provided via SCOS.

- here's the announcement
- read Mallya's column