Contract research organizations expectations

Verifying the identity of cell lines chosen for use should also become a routine task in cell culture laboratories. The number of documented cases of misidentification and cross-contamination of cell lines is growing (Chatterjee 2007). The National Institutes of Health (NIH) issued a notice on November 28, 2007 (NOT-OD-08-017) recognizing the importance of this issue and suggesting that peer reviewers of grant applications and manuscripts submitted for publication should assure that scientists employ available authentication procedures. As the pressure to authenticate cell lines continues, we can expect core facilities and contract research organizations to expand their offerings of such services. 

In addition, a reality of the pharmaceutical industry at present is the outsourcing of some of all of the synthetic chemistry for a project. To the list of existing questions must be added several others. Which contract research organization(s) will you choose, and what can they be expected to accomplish How will you handle electronic lab notebooks, documenting intellectual property issues and other legal issues How do you handle the logistics of quality assurance, shipping, and customs To help you address each of these, it is prudent to reach out into your broader network to get opinions from others not only in your company but also across the industry. 

A multitude of external providers are used to deliver services in clinical trials, for example CROs, site management organizations (SMOs) and academic research organizations (AROs). To ensure that they are capable of providing the services in a reliable manner and to the standards expected in compliance with current regulatory requirements, capability audits are conducted at service providers prior to contracting. 

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