System speeds outsourcing-options analysis

For Massachusetts biopharma Cubist Pharmaceuticals, clinical outsourcing efficiency has become a priority. The maker of drugs for use in acute-care environments currently has two Phase I trials and one Phase II trial under way. Another drug candidate is at the lead-optimization stage.

"New clinical outsourcing models and alternatives have created much more complexity for our clinical trial planning," says Dr. Santosh Vetticaden, chief medical officer at Cubist. The company has adopted ClearTrial's Clinical Trial Operations (CTO) software.

Vetticaden's research-partner selection process involves a trial-strategy evaluation as the first step. Strategies include conducting a trial primarily with Cubist personnel, outsourcing one or more trial functions, or having the research partner take on most of the trial activities.

"We typically consider more than one vendor or CRO for a particular activity before we select a partner for any given trial," says Vetticaden, via email. Part of the process involves assessing available technologies "that would provide us the needed insights."

He says he looks to the ClearTrial system to help researchers quickly compare cost scenarios for the different outsourcing approaches. The CTO software is built on an activity-based architecture, according to a ClearTrial announcement. It supports "all outsourcing models and contract types, and calculates labor costs across 70 different countries."

- see the Cubist pipeline [1]
- here's the ClearTrial announcement [2]

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The fall of clinical trial software [4]