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Mar 15, 2010 (Vol. 30, No. 6)

Points to Consider in Choosing a CRO

Knowing When to Rely on In-House Capabilities and When to Outsource Is Critical to Success

  • Making the Right Decision

    Although there is no standard formula for outsourcing, there are certain steps companies can follow to help choose the right CRO for a specific study. Nancy Havrilla, senior director of clinical operations at Achaogen, said that key considerations vary depending on the study, the indication, and needs. These include the life cycle of the study (timing, study management strategy), RFP, protocol synthesis, vendor contract, study maintenance, site closing, and database lock.

    Havrilla stressed the importance of a good contract. She suggested starting with an accurate RFP to provide a more accurate cost assessment. “I always include a statement that assumes all documents go through a two-review cycle unless otherwise noted. This is to avoid each company working under different assumptions.”

    It’s also important to include timing of activities into the contract. The vendor-selection process should not be rushed. It should be determined what will be outsourced and selection criteria should be listed. As a sponsor, it’s important to know what can be managed within a specific budget. Scheduling periodic project review meetings helps to keep everything on track. “There’s a lot of pressure to do things faster without spending additional money. Managing expectations and planning helps to minimize the amount of pressure,” added Havrilla.

    It’s best not to end a relationship with a CRO prematurely; there are short- and long-term expenses associated with changing vendors. Havrilla suggested that the best way to prevent this is to act quickly as soon as any issues arise. Also, examining learned lessons and areas that need improvement helps the relationship. “I think finding the right CRO is not hit-or-miss. There are steps to take to find the right group for a particular project. Having selection criteria and looking long term to build relationships is a great way to save money and time.”

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