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International Clinical Trials
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Over the past few years, outsourcing clinical trials has become an
attractive option for sponsored pharmaceutical research. Therapeutic
expertise, resource management, technological advantages and cost
cutting are some of the primary reasons for any biopharmaceutical
sponsor to outsource clinical trials. This has led to tremendous growth
in the size and number of CROs in the past two decades. Most of them
position themselves as a fullservice CRO in the drug development market,
although – based on study-specific requirements – the majority of them
are ready to sub-source for their functional needs.
Collaborating
with a CRO is now an essential and significant step for sponsors during
the clinical development process. The dynamic shift in outsourcing
methodology and service fragmentation has left them with critical
decisions to be taken at the juncture of CRO sourcing. There are
variable sizes of companies on both the sponsor and the CRO side, and
the principle of ‘one size fits all’ is not pragmatic from an
operability perspective.
Different Options
Full-service
and functional outsourcing remain as two distinct but basic models of
collaboration. Traditionally, per-study outsourcing has been followed
until recently, when strategic partnerships between Big Pharma and
sizeable CROs began gaining popularity.
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Clinical Trials in Russia Orange Paper: 1st Quarter 2014
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2. Nearly 100% patient retention
3. GCP trained and certified Investigative Sites generating high quality data
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