Selection criteria rated "highly important" in the present survey are: therapeutic area expertise (50%); strong reputation
(50%); demonstrated ability to deliver patients (50%); responsive turnaround of proposal (44%); and significant cost advantage
(42%). These criteria are very consistent with past surveys conducted among sponsor companies by CenterWatch, with a couple
of notable exceptions. Whereas in 1996 nearly 20% of companies rated "size of CRO" as an important selection criteria, only
3% of respondents do so in the present survey. In 1996, 38% of companies rated "full range of services" as "highly important,"
compared with 29% of respondents who do so in the present survey. These latter two findings further support the notion that
sponsors are confident in, and favoring, their ability to flexibly select and manage CROs of varying sizes and service offerings.
Contracting with providers The time required to negotiate the terms of the service agreement often creates a significant delay in project initiation.
One suggested approach to saving time is to initiate work under a "letter of intent." This approach is usually discouraged
by sponsor attorneys, as evidenced by less than one-third of respondents (23%) reporting that they frequently (>50% of the
time last year) initiated projects under a letter of intent. Support for another approach, the "master service agreement,"
was only slightly better; 38% reported that they frequently used them. Project governance Project kick-off meetings between sponsors and providers are becoming more common. However, the survey results suggest that
the practice is not widespread. Only one-third of the respondents (36%) reported that they usually (more than 75% of the time)
initiate projects with a formal kick-off meeting. Kick-off meeting activities rated "highly important" by the respondents
were: review procedures (63%); clarify roles and responsibilities (62%); review protocol (60%); define communication pathways
(56%); and agree on how issues will be resolved (50%). Despite the fact that sponsors often complain about CRO staff turnover,
only 20% of the respondents rated "discuss how staff turnover will be managed" as a "highly important" item for the meeting
agenda. Techniques rated "highly important" to ensure that the CRO meets the sponsor's expectations were joint periodic review
of metrics (49%) and contract language (27%). Rewards and penalties were not rated highly (8% and 9%, respectively).
Figure 1. Quality of full-service CROs over the past two years (337 respondents).
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Quality of provider services Respondents' feedback on the quality of full-service CROs is shown in Figure 1. Nearly half of the respondents (48%) reported
that the overall quality of full-service CROs has stayed the same during the past two years. Improved performance was noted
by 39% of the respondents, while only 13% indicated that overall CRO performance has worsened. These results suggest an improvement
in the perception of CRO services, as compared with a 1998 survey by CenterWatch6 in which 40% of respondents reported that overall CRO performance had worsened.
Figure 2. Quality of niche-service CROs over the past two years (335 respondents).
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Equally good marks were reported for niche-service CROs (see Figure 2). Improved performance was noted by 47% of the respondents,
and an additional 47% reported that overall quality of niche-service CROs has stayed the same during the past two years. Only
6% indicated that niche-service CRO performance had worsened.
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