Making a Commitment
A small but growing number of pharmas are pioneering more strategic, partner-based outsourcing. The process begins with an
in-depth assessment of the company's core competencies, determining which functions are best performed in-house, and which
should be handled by a CRO offering greater expertise and efficiency. "We're deliberately trying to establish alliances because
we believe vast [CRO] development experience [and expertise] can be accessed that way," one biotech exec told us. In fact,
on an annual basis, the top ten CROs have managed a much higher volume of work in many areas of clinical research than their
sponsor partners. The five largest CROs have succeeded in submitting more total INDs and NDAs than almost any pharma or biotech
in the industry. (For more on CRO vs. in-house performance, see "CRO Development Speed and Quality," page 65.)
In these partnerships, the goal is to build a team with complementary competencies to take full advantage of what each party
brings to the table. Sponsors look to retain senior level expertise (for project planning and concept sheet development),
while reducing the number of internal staff. As a result, sponsors can streamline operations by managing rather than doing
The selection of the right CRO provider—based on such criteria as expertise, capacity, positioning, and culture—is essential.
(See "A New Approach to Selecting a CRO Partner," page 65.) From the outset, there must be a shift from capacity- and project-based
to competency- and portfolio-based outsourcing. On the CRO side, this affords an opportunity to plan for upcoming activity,
and reduces the likelihood of cost overruns.
Governance is a shared responsibility. Once a sponsor has picked a partner and determined the scope of the work, the companies
together create a senior level governance committee. Members, chosen from both companies, meet once or twice a year to review
projects. Meanwhile, lower level committees implement the relationship on a day-to-day basis. The sponsor and the CRO rely
on a set of coordination operating procedures (COPs) to ensure that each party's SOPs are consistent, integrated, and compatible;
conflicts are resolved by the appropriate mid- or senior level committee. In this way, the CRO has greater autonomy to leverage
its expertise and efficiencies.
Sponsors tend to work with only a few full-service CROs in partnership relationships, and the responsibility of managing niche
service CROs is often transferred to the partner provider. The sponsor's time is focused instead on overall strategy and planning,
as well as high level management of the relationship's performance.
Nearly all of a drugmaker's functional tasks can be outsourced in partnership relationships. Companies are increasingly receptive
to using CROs for protocol development, site selection and management, study monitoring, data management, biostatistics, medical
writing, quality assurance, and routine regulatory affairs tasks.