SOURCE: Cutting Edge Information

October 16, 2008 07:18 ET

According to Cutting Edge Information, Companies Now Outsource Less of Clinical Development Budget

RESEARCH TRIANGLE PARK, NC--(Marketwire - October 16, 2008) - Pharmaceutical companies across the industry have significantly cut outlays to outsourcing as a percentage of clinical development budgets, according to "Streamlining Clinical Trials," a new study by pharmaceutical business intelligence leader Cutting Edge Information. Comparison with earlier research by Cutting Edge Information in this arena reveals that reductions occur in every phase.

The new study shows that outsourcing as a percentage of the budget has reduced an average of 20% for every phase from 2006 research. In Phase 1, the percentage of the clinical development budget outsourced dropped from 65% in 2006 to 35% of the average 2008 budget. The percentage increases as companies proceed into later phases of a trial.

According to the study, in efforts to cut costs, companies are not allowing vendors the same free reign as in the past. A number of companies have instated increasingly more milestone based payments. Other companies have started outsourcing only when the necessary resources are not available in-house.

"Companies are now realizing that outsourcing does not necessarily make things easier, cheaper, or remove a burden from their plate," says lead author of the report David Richardson. "Research has appeared arguing against the cost-saving effects of outsourcing. Also, companies are being more frugal. Keeping things in-house grants easier oversight because of institutional proximity, ensuring efficient and competent work, instead of spending the same time managing a CRO."

"Streamlining Clinical Trials" (www.clinicaltrialbenchmarking.com) covers resource allocation, performance measurement, continuous process improvement, patient and investigator recruitment and adaptive trial designs. Data include clinical development budgets, clinical operations team structures and staffing levels, performance measurement and management, clinical operations hurdles and process improvement tools and tactics. The report focuses on three aspects:

Patient Recruitment: Patient recruitment continues to dominate clinical timelines and budgets. The report devotes an entire chapter to this challenge, providing the latest trends and tools in recruitment.

Budgeting and Performance Assessments: Clinical project managers must set clear performance expectations and measure and manage trials. The report provides clinical spending benchmarks to assist in trial budgeting and planning.

Clinical Operations Structure and Work Flow: Clinical trial management team members must know their roles and responsibilities, and communication with vendors and investigators must be seamless. The report outlines major obstacles clinical teams face and presents real-company, proven solutions.

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