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What makes
good clinical project management? Clearly, the project must be delivered on
time, within budget and with quality which is acceptable.
Considered
that the largest part of the protocol execution time is consumed by enrolment
it is understandable that most of the key delivery factors are met if patient recruitment
is on-time. So how is this achieved? How the project will actually be carried
out starts at the protocol. Next, the regulatory and legal environment should
be identified since in the EU these differ per country.
So, if done
right, it starts with the identification & evaluation of specific protocol
and regional factors that affect enrolment. Combining in-house expertise with
the knowledge of the sites in each country will provide valuable information in
order to make clinical project management successful; it will determine how the
clinical project is offered and how it’s carried out.
As a result
CP managers must have strong communication skills as they are the crucial
intermediate between the sponsors of the clinical projects on the one hand and
the CRO, including the investigator network, on the other hand.
The ability
to build long term relations with team members within the company as well as
with investigator teams in the field is a key issue; this is not only vital at
start-up but also during the recruitment phase and during the follow-up period
of any clinical project.
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