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Alternative strategies for approaching drug discovery and development have emerged in response to tightening budgets.  An appealing trend is the shift toward the use of contract research organizations (CROs) to perform the range of experiments required to show safety and efficacy in drug development.   At Assay Depot, we provide a platform for finding the right CRO to meet your needs.   However, CRO selection requires navigating the logistics of quality and performance criteria necessary to ensure the program moves forward in a timely and productive manner.

What are the key factors to consider when selecting a CRO for your drug development program?   Alzheimer’s Drug Discovery Foundation (ADDF) recently summarized their suggestions for navigating CRO selection 1.  Here, we summarize their thoughts and add our insights from years helping support researchers establish and push forward drug development programs.  First, when should CRO use be considered and what are the benefits of CRO use?  Then, we share insights into evaluating CROs including program oversight and company structure recommendations.

The decision to outsource projects can be empowering and strengthen a growing research or development program.  Finding the right CRO to meet your needs requires evaluating your company’s strengths and weaknesses to determine where CRO use will complement your in-house expertise.  Outsourcing enables researchers to rely on the expertise and experience of others.  CROs often bring years of experience with overseeing and managing drug development programs which can be a great benefit if your company lacks that experience.  Additionally, CROs often specialize in specific therapeutic areas and the added expertise in specific therapeutic can be extremely important for timely progress.  In addition, CROs have established protocols and standards that meet regulatory requirements.

The reputation of a company and drug development program can be enhanced through the use of CROs.  Given the current pressure for timely and repeatable progress during drug development, validation by a well known CRO can build a stronger program that is more attractive to funding agencies and for partnering.

Outsourcing to a CRO can increase your drug development program’s success by increasing the quality of your program, adding experience and expertise to support timely progress, and consequently establishing a stronger reputation.  Give the extensive requirements necessary for successful regulatory compliance and attracting continued financial support, CROs add significant value to a research or development program.  To learn about recommendations on CRO selection, stay tuned for  next week to read about evaluating CROs – from program oversight to company structure.

 

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.