The role of clinical compliance
within sponsor companies is relatively new,
and it will ultimately be a critical one.
loop so the sponsor is involved in
sanctioning changes to the frequency
and intensity of monitoring as it occurs.
WHAT TO WATCH OUT FOR
The process can be complicated by
several factors, the first of which is to
be mindful of how the CRO proposes
the budget and scope. Research sites
with infrastructure and highly skilled
staff are crucial to fully realize the
cost savings, but they are often not
identified as such when the project
budget is initially defined. The gulf
between many sponsors and CROs having an open dialogue built on trust
may prevent a collaborative approach
that is essential to defining the budget
because there are many variables that
can give the vendors concern about
scope issues once the project begins.
I recognize there are companies out
there trying a risk-based approach,
and I applaud them for their willing-
ness to update their procedures. But
there won���t be widespread adoption
until lessons learned by those who���ve
tried it can be shared publicly to demonstrate how well it works to appease
those who are too nervous to take
the plunge. Risk-based monitoring is
not a panacea and not a one-size-fitsall solution. However, CRAs can and
should be teachers, problem solvers,
and compliance managers, not data
point verifiers and box checkers.
INDUSTRY LEADER
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