Die Studie beschreibt die neuesten Entwicklungen und Erfahrungen im Outsourcing von 18 deutschen Vfa-Mitgliedsunternehmen. Um diese Fragen zu beantworten, wurde eine Umfrage unter den deutschen vfa-Mitgliedsunternehmen durchgeführt. Darüber hinaus hat sich auch die Art des Outsourcings in dieser Zeit verändert.ĭies wirft die Frage auf, ob und wie die Sponsoren die Fähigkeit, geeignete CROs auszuwählen und zu überprüfen, beibehalten und welches Know-how noch in den Forschungs-, Entwicklungs- und anderen Abteilungen vorhanden sein muss, um eine angemessene Aufsicht zu gewährleisten, wie sie auch vom Gesetzgeber und den Überwachungsbehörden erwartet wird. In den letzten Jahren haben sich sowohl die Anzahl als auch der Umfang der ausgelagerten Tätigkeiten in der pharmazeutischen Industrie stark erhöht. This survey shows that the current implementation of oversight processes in the participating companies covers all relevant areas to ensure highest quality and integrity of the data produced by the outsourced clinical trial. For globally acting and outsourcing sponsors, oversight processes need to be aligned with regards to local and global perspectives. A large amount of guiding documents, processes and tools are used to ensure an adequate oversight of the services performed by the CRO(s).įinally the guiding principles for all oversight processes should be transparent communication, a clearly established expectation for quality, a precise definition of accountability and responsibility while avoiding silo mentality, and a comprehensive documentation of the oversight’s evidence.
Oversight process by like professionals trial#
This study shows that the majority of companies apply a full-outsourcing, preferred-provider model of clinical trial services, with the clinical research department playing the major role in this process.
Oversight process by like professionals how to#
It concentrates on measures how to implement Quality Assurance (QA) when performing outsourced clinical studies. The survey describes the latest developments and experiences in outsourcing by 18 German vfa member companies. In order to answer these questions, a survey was conducted among the German vfa member companies. This raises the question of whether and how sponsors retain the capability to select and to control the contract research organizations (CROs) involved and what expertise still has to be present in the development department as well as other relevant departments to ensure adequate oversight, also in line with the expectations of regulators and health authorities.
In addition, also the type of outsourcing has changed significantly in that time. In recent years, the number and scope of outsourced activities in the pharmaceutical industry have increased heavily.
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