Outsourcing in the clinical research sector has reached a critical juncture in its evolution. Pharmaceutical companies are
poised to gain major benefits from the scale, scope, and expertise of contract research organizations (CROs)—if they are willing
to relinquish control and let their CROs do what they do best.
That's the principal conclusion of a survey conducted by consulting firm Everest Partners L.P. (Dallas, TX) and presented at April's Partnerships with CROs conference sponsored by the Institute for International Research
(IIR). This was the third year that Everest and IIR conducted the survey. Everest is a consulting firm focused exclusively
on outsourcing in a wide array of industries.
According to Todd Hintze, Everest's industry principal for healthcare, the objective of the survey was to gauge whether research
and development (R&D) outsourcing in pharma is delivering the same level of market value that outsourcing has delivered in
other sectors such as information technology and business processes.
In Everest's view, true outsourcing requires the transfer of ownership of a business process from the client to the service
provider. In a true outsourcing relationship, the client's principal concern is for the results of the process rather than
its mechanics. The underlying rationale is that the service provider can do the job better, faster, and cheaper because it
has superior economies of scale, greater depth of experience, better technology, and access to lower-cost labor markets.
According to Hintze, pharmaceutical companies are missing out on the full advantages of clinical research outsourcing because
they are unwilling to relinquish control. Although some of this reluctance reflects the industry's regulatory environment
and prominence as a target for lawsuits, Hintze says that pharmaceutical companies primarily need to get their "blocking and
tackling" right. In particular, they need to be better at defining their outsourcing objectives, establishing governance mechanisms,
and training staff responsible for managing outsourcing relationships.
The understanding and alignment of objectives between clients and CROs was one of the biggest problems highlighted in the
Everest survey. Hintze says that companies are often inconsistent in following their stated objectives; for instance, stating
initially that innovation is a prime objective, then focusing on price when it comes time to negotiate the contract. He also
notes that agreements and relationships developed among operational people are often undone once the negotiations are handed
off to legal and procurement staff.
Metrics should measure progress toward objectives, so developing effective metrics can't be achieved unless the objectives
are aligned. Too often, metrics are defined after the project has started, rather being defined in the service agreement.
Furthermore, notes Hintze, both the client and the contractor should have incentives to work toward the common objectives,
and both should feel pain if they don't.
Pharmaceutical companies also fail to pay adequate attention to relationship governance, says Hintze. Too often, governance
is not dealt with until a problem arises after the project is launched. Without a proper structure for resolving problems,
including escalation to higher management levels, issues can remain unresolved for long periods, jeopardizing project objectives
The overwhelming majority of pharma company respondents to the Everest survey indicated that they prefer doing work in-house
when speed or cost is of paramount importance. Interestingly, though, executives and operational staff see things differently:
Executives are more favorably disposed to outsourcing, while the line-operations staff prefers keeping work in-house.
This suggests that there is a missing link between executives' strategic vision and the day-to-day realities of managing outsourcing
projects. The Everest research suggests that the disconnect may be in training: More than 60% of respondents indicated that
they received either no training or only on-the-job training for their outsourcing management responsibilities.
Although Hintze did not say so outright, the Everest survey suggests to me that pharmaceutical executives aren't providing
adequate leadership in moving their organizations toward a more strategic approach to outsourcing. Accepting the notion that
CROs are as competent as in-house staff, if not more so, is still a cultural challenge in most major pharmaceutical companies.
The reluctance results from a mix of arrogance bred during years of financial success and the fear of compounding already-high
risk arising from scientific and market factors with the additional risk posed by the loss of control over key processes.
There may also be reluctance on the part of some managers to adopt outsourcing because it means a reduction of their headcount.