Privatsphäre-Einstellungen

Qualitätssichernde Maßnahmen beim Ausgliedern von Aufgaben aus dem Bereich der klinischen Forschung an ein Auftragsforschungsinstitut

Dr. Friedbert Theis¹ und Dr. Ferdinand Hundt²

Sanofi-Aventis Deutschland GmbH¹, Frankfurt/Main (Germany), und Sanofi-Aventis Deutschland GmbH², Berlin (Germany)

In many pharmaceutical companies outsourcing is a necessity to conduct additional duties or to develop projects outside the company. The expected quality of the job completion is an important criterion for the selection of a Contract Research Organisation (CRO).
A quality control / quality assurance is recommended after checking, if the CRO offers the duties needed by the orderer. This is done before the project / the study is outsourced, during it is conducted and after it is finished. The result is the following four-phase program.
1st Phase: Check of credit history and land tenure
2nd Phase: Qualification audit
3rd Phase: Audit during the study is conducted
4th Phase: Evaluation of the CRO during and after the study by the speciality departments of the orderer
The qualification audit should be repeated every 2 – 3 years (re-audit).