Contract Research Organizations
WHAT SPECIFIC ADVICE DO YOU HAVE
FOR EXECUTIVES INVOLVED IN THE
INSOURCING VERSUS OUTSOURCING DECISION?
Burhop: The key to outsourcing preclinical studies is to conduct
solid and extensive up-front research on each CRO under consideration for a particular study. Go with the company that genuinely
cares about your product development and is willing to work with
you as a partner versus just another customer bringing in money.
Reputation and scientific expertise, combined with quality and
timely output, are key. In the end, much of this is about establishing a relationship with a CRO and, in particular, with the study
director assigned to your study. They have to be extensions of your
internal team. Consider all of the trade-offs of cost relative to lost
time, training of resources, ongoing need for special resources,
talent, and ultimately the quality of the work.
Hubbard: We are moving into an era where ���transactional��� insourcing of personnel to support projects, or outsourcing of full programs
to CROs needs to be part of a more integrated and overall drug development strategy. Fiscal pressure on both sponsors and CROs continues, while the need to improve quality and enhance delivery and
competitiveness cause opposing pressures. The solution is to apply a
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The CRO Leadership Awards 2013
more strategic approach. For example, specific technical, operational,
or regional capabilities can be accessed using CROs without building internal infrastructure. This is highly useful when new product
is acquired through licensing or via an acquisition, thus maintaining
a high degree of flexibility for noncore areas. A more long-term perspective allows organizations to learn and grow together, significantly
reducing the cost of sales and overhead within the sponsor organizations, improving staff utilization, and reducing operating expenses
overall. It also provides a foundation for joint innovation which
can be shared by both organizations. The solution needs to be fully
accepted throughout the sponsor and CRO organizations, since it
may create constraints on the number of providers to be utilized ���
virtually eliminating the traditional Request for Proposal, RFP, and
Request for Information, RFI, processes.
Williams: It is vital to determine early on the critical proprietary
aspects of the program and build those within your organization.
Outsource only noncritical or ���programmed��� aspects of your
program. Continually assess/reassess and determine what critical
initiatives may need parallel tracks.
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at www.clinicalleader.com.