Trial Project Management (Phase I - IV)
of a drug is a lengthy, costly and complex process, which may
be referred to as project management.
is a project?
is a defined piece of work which has agreed timelines and requires
a team of people with diverse skills to work together to achieve
a common set of objectives.
of any project needs to be carefully defined from the outset and
this is especially important if any part is to be outsourced.
Definition of the project scope should clearly lay out the anticipated
deliverables, timelines and cost estimates. A critical success
factor in any project is having an appropriate “sponsor”
who is of sufficient seniority to be able to exert influence at
the cross-functional level. The sponsor needs to ensure that:
are those who will be affected by the project. They may benefit
as a customer or be required to contribute as a resource provider.
Stakeholders will be involved in key decision-making, e.g., stopping
the project or approving major changes in its scope. Sponsors
and stakeholders need to “own” the scope of the project,
i.e. the definition of its boundaries. With the scope defined
and stakeholder support in place, planning and scheduling can
begin and thus a project can be executed to successful completion.
We at Consortium Clinical
Research are experienced and understand the integrities
that are involved in the ideal project management scenarios that
are demanded from a clinical trial. With our technical
competence and speed of operations,
we ensure that each Sponsor is kept at peace and relaxed regarding
the status of progress of the clinical trials that are undertaken
by us to execute the functionalities of a Clinical Trial Project
has been resourced from Principles of Clinical Research, 2001.