RESEARCH TRIANGLE PARK, NC − Pharmaceutical business intelligence leader Cutting Edge Information announces the launch of a new industry report, “Managing Investigator Initiated Clinical Trials: Structure, Process and Strategy” (http://www.InvestigatorInitiatedTrials.com).

Analysts compiled the report using information gleaned from interviews and surveys with investigator sponsored studies (ISS) program managers, clinical development executives, and medical affairs experts in the pharmaceutical, biotech and medical device industries. The report analyzes the composition and resource allocations of drug companies’ internal departments responsible for managing investigator initiated clinical trials (IITs). The report also examines every aspect of pharma’s internal IIT management processes, including the receipt of study proposals, company evaluations and grant approvals, and study oversight and tracking.

“We published ‘Managing Investigator Initiated Clinical Trials’ after several of our clients and research partners expressed an interest in having an off-the-shelf guide that they could use to either establish their own internal IIT management processes or to benchmark their existing departments against industry standards and best practices,” said Eric Bolesh, research team leader at Cutting Edge Information and chief author of the report.

According to Hess, the report has been made available for sale through the company’s website. Industry executives and others interested in the topic can download a summary of “Managing Investigator Initiated Clinical Trials” or purchase the report at http://www.cuttingedgeinfo.com/investigatorinitiatedtrials/ .

Case studies, best practices and key challenges are the foundation of the report’s qualitative information. Scores of quantitative benchmarks and resource allocation data back up the report’s conclusions and provide the necessary framework for IIT and clinical program management executives to benchmark their performance. Among the 200-plus metrics included in the report are:

* 2006 IIT department staffing levels
* 2006 IIT department budgets
* 2005 and 2006 IIT spending by company
* Time from receipt of IIT proposal to decision response
* Investigator sponsored trial management performance measures

Hess also says that the report can be used by companies as a step-by-step guide to establish IIT departments and internal processes and controls. “We intended for it to be used as a manual for companies set up their own IIT management infrastructures,” Hess says.

To view a summary of “Managing Investigator Initiated Clinical Trials,” visit http://www.cuttingedgeinfo.com/investigatorinitiatedtrials/ or contact Jon Hess at eric_bolesh@cuttingedgeinfo.com or 919-433-0211.

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