Search

Outsourcing of activities is common and increasing in the pharmaceutical industry, not only for clinical trial conduct, or other trial related aspects but also for biostatistics and data management. This raises the question of whether and how sponsors retain the capability to select and to control the CRO(s) involved and what biometrical expertise still has to be present in the sponsor company to ensure ad- equate oversight. Not only in the case of partial outsourcing but espe- cially in the case of complete outsourcing sponsors have to find the right balance between a complete "hands off" approach and a resource intensive in-house shadowing of activities to fulfil the requirements. In order to answer these questions, a survey was conducted among the German vfa member companies. This article discusses the specific oversight topics for the outsourcing of data management and biostatistics services, e.g. requirements for data quality, coding, and statistical analyses. This study shows that the majority of the companies use the same CRO for biometrical services as for rest of study services and that there is a preferred provider for these services in 65% of the companies. There are established, specific requirements for the main deliverables of biometrical services: For coding and data standards these are predom- inantly industry standards (MedDRA, CDISC). For statistic outputs and data quality mainly sponsor standards are used. The adherence to the requirements is mainly checked via spot-checks, and standardized checklists are mainly used for checking data standards. Generally, in all companies participating in the survey, there is an awareness of the necessity of biometrical oversight. Although not necessarily perfect yet, all companies took measures to ensure good biometrical oversight and there is a common understanding, that it is not an option to resign from biometrical oversight. [ABSTRACT FROM AUTHOR]

In recent years, the number and scope of outsourced activities in the pharmaceutical industry have increased heavily. In addition, also the type of outsourcing has changed significantly in that time. 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 order to answer these questions, a survey was conducted among the German vfa member companies. The survey describes the latest developments and experiences in outsourcing by 18 German vfa member companies. It concentrates on measures how to implement Quality Assurance (QA) when performing outsourced clinical studies. 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. A large amount of guiding documents, processes and tools are used to ensure an adequate oversight of the services performed by the CRO(s). Finally 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. For globally acting and outsourcing sponsors, oversight processes need to be aligned with regards to local and global perspectives. 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. [ABSTRACT FROM AUTHOR]