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PHARMACEUTICAL INDUSTRY :
Clinical Trials Efficiency Improvement |
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| | Client: |
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A major pharmaceutical
company that supports a large number of clinical trials conducted
by third parties. While the pharmaceutical company normally supplies
the drug free of charge to these independent investigators, they are
not the sponsors of the studies.
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| | Problem: | |
Process inefficiencies
were causing excess cycle time in phase IV third party studies; problem
areas included contract negotiations, protocol development and drug
supply. Ambiguity in roles and responsibilities were also creating
unnecessary hand-offs and uncertain follow through. In some areas,
there weren't enough FTE resources available to effectively support
and track third party studies. Additionally, the IT system was not
user friendly or transparent enough to effectively track and communicate
third party study information.
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| | Approach: | |
A team-based
approach was used to define opportunities for improvement, and then
develop recommended solutions. The objective was to design an efficient
method for conducting the Third Party Studies (TPS) process, building
upon current internal procedures and Phase IV guidelines. Along the
way Tunnell confronted and overcame significant process and role clarification
hurdles.
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| | Results:
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Tunnell constructed
a series of recommended solutions, including:
Create clinical project teams with dedicated resources for TPS
Establish a triage process to identify priority TPS, and appoint a study shepherd for them
Begin routine TPS priority project review meetings
Establish approved contract limits to expedite negotiations
Create a steady state drug inventory and use bulk packaging and site labeling where possible
Appoint a dedicated drug demand manager(s)
Standardize proposal evaluation tools across brands
Support the initiative for an external vendor to package, label, and distribute the drug supply
Establish a regulatory SOP for TPS
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