Contract research organizations (CROs) often have experience overseeing all aspects of a drug development program. ADDF recently shared their insights on navigating CRO selection 1. In Part 1 of this series, we discussed how the experience found in CROs can benefit a drug development program. Here, we highlight key factors to consider for CRO selection including program oversight issues. In the Part 3 next week, we will discuss evaluating CROs and their company structure.
Consulting and project management
Drug development programs run more smoothly when there is a designated project manager. A key factor in CRO selection is to determine if the project manager will be an internal or external person. Early drug discovery programs often select the principal investigator as the project manager. In this case, the investigator should create strong advisory relationships with consultants and key players at the CROs. Later in drug development, the experience of a dedicated project manager or management company is advisable.
Data management and handling
Another key factor in CRO selection is how data accuracy, confidentiality, and security will be addressed. Clear communication of the data management system that will be used is essential. Precedent of how data has been processed and stored should be available and include control data sets and possibly FDA audit records. Clear communication of data oversight with regularly scheduled reviews should be incorporated into the data management plan.
The structure of contracts can clearly support progress of the drug development program. CRO selection should include contacting several companies and investigating the different options and contract that are available. At Assay Depot, our services assist researchers in finding multiple providers to initiate contact. Contracts should include milestones, confidentiality agreements, and payment. Varied models for agreements based on the stage of program, risk involved, and key requirements and functions needed are a few things that can affect the structure of a contract. In some cases, the CRO can share some of the risk to assist the progress of the program in return for a portion of the returns.
CRO selection involves critical assessment of how program oversight will be managed. Importantly, the structure of the CRO should be clearly assessed as discussed in Part 3 next week.
1. Lane, R.F., Friedman, L.G., Keith, C., Braithwaite, S.P., Frearson, J.A., Lowe, D.A., Longo, F.M., Refolo, L.M., Watterson, D.M., Tsaioun, K., Shineman, D.W. and Fillit, H. M. Optimizing the use of CROs by academia and small companies. Nature Reviews Drug Discovery. 2013. 12:487-488.