< previous page	page_330	next page >
Page 330 CRO Evaluation Criteria Capabilities Needed range of services, facilities, and equipment Global capabilities Reliable record-keeping systems Adequate security measures Personnel Needed range and mix of expertise and experience Appropriate extent of expertise in therapeutic class Ability to participate in collaborative strategic planning Good training program in place Quality of Work History of experience in appropriate therapeutic area Record of on-time and accurate results and reports Regulatory History Results of FDA inspections Experience with regulatory submissions Financial Considerations Proven financial stability and resources Financial independence from other sponsor organizations Able to provide sponsor maximum value for cost proposed Standards and Ethics SOPs meet appropriate standards QA program in place Good business practices in place Confidentiality assurances Compatibility Corporate culture compatible with sponsor's Flexibility in business practices to meet sponsor needs Previous positive experience with sponsor At this stage, the information-gathering process should go beyond contact with the CRO to include discussions with CRO bankers or venture capitalists, scrutinization of financial statements, and the pursuit of other avenues of information. Only by gathering as much relevant data as possible can a company make the most informed choice. VI. Making it Work: How to Lay the Groundwork for a Successful Project Relationship What makes a relationship between a sponsor and a contracted-in CRO work to its fullest potential? It depends entirely on the willingness of both parties to let the following attributes define the relationship.
< previous page	page_330	next page >