Bioanalytical outsourcing strategy at Janssen Research and Development
Bioanalysis
|June 25, 2014
Summary
Bioanalytical workload is now split between in-house teams and external contract research organizations. Janssen
Area of Science:
- Bioanalytical chemistry
- Pharmaceutical research
- Contract research organizations
Background:
- Modern bioanalytical laboratories divide work between in-house and outsourced support.
- Outsourcing to contract research organizations is a common practice.
Purpose of the Study:
- To outline the outsourcing strategy of the Janssen-regulated bioanalytical group.
- To detail criteria for selecting contract laboratories.
Main Methods:
- Describing the outsourcing strategy of a specific bioanalytical group.
- Discussing criteria for selecting contract research organizations.
- Reviewing experiences with outsourcing clinical studies to China.
Main Results:
- A strategy is presented for balancing in-house and outsourced bioanalytical workload.
- Criteria for selecting and limiting the number of contract laboratories are discussed.
- Specific attention is given to outsourcing clinical studies to China.
Conclusions:
- Keeping assay and compound knowledge in-house is key to a successful outsourcing strategy.
- A selective approach to outsourcing partners is crucial.
- Experience with outsourcing to China is highlighted.
