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Clinical Outsourcing Costs Challenge Drug Companies, Says Cutting Edge Information
| Source: Cutting Edge Information
RESEARCH TRIANGLE PARK, NC--(Marketwire - August 31, 2009) - In the drug industry, clinical
trials carry price tags that run well into the tens of millions of dollars.
Managing such costs demands a sure hand, and trial sponsors go to great
lengths to monitor and manage funds allocated to vendors.
Outsourcing is a key part of drug development. The Association of Clinical
Research Organizations (ACRO) reports that industry analysts expect
biopharmaceutical companies to outsource 35% of their trials over the next
five years -- up from a quarter of trials today. Demand for vendor
services will grow, they predict, at a rate of 15% annually.
Trial monitors and managers are the most commonly outsourced positions,
according to Cutting Edge Information, publishers of "Strategic Clinical
Sourcing: Managing Costs and CROs." Depending on need, trial sponsors will
outsource other roles, such as biostatistics analysis, medical writing, and
even senior-level management of clinical tasks.
Outsourcing offers sponsors an opportunity to define and manage clinical
costs very closely. Thanks to clinical research organizations (CROs),
sponsors may pursue drug development without maintaining expensive
infrastructure or in-house specializations. On the other hand, poor
planning or execution can lead to cost overruns that strip outsourcing of
its financial benefits.
"Clinical planners determine what can be done in-house and what should be
outsourced," said Jason Richardson, president of Cutting Edge Information.
"Then the challenge becomes managing trial progress and associated costs."
Outsourcing budgets accommodate fees for different study roles and tasks.
According to survey data, trial managers and monitors average $154 and $113
per hour, respectively. Other positions fall between $100 and $200 per
unit hour, with some specialized roles reaching higher levels.
Outsourcing contracts can be straightforward or complicated, depending on
sponsor needs.
"Clinical outsourcing means different things to different companies,"
Richardson said. "Some companies use outsourcing as a last resort, others
as a major cog in the gears of development."
No matter what, managing clinical costs remains an issue for all of them.
The report, "Strategic Clinical Sourcing: Managing Costs and CROs,"
(http://www.clinicaloutsourcingstrategy.com) discusses the benefits and
drawbacks of clinical outsourcing. It examines costs and trends while
providing strategies for addressing common obstacles in CRO selection and
management. It also shows trial sponsors how to formulate a proactive
outsourcing strategy, establish criteria for selecting a vendor, and manage
day-to-day CRO relationships.