Top Three Questions to Ask During CRO Selection
Poorly performing sites can cost sponsors millions of dollars. The success of a clinical trial will often depend on the sites’ abilities to conduct clinical trials in timely manners. Because of the costs involved, sponsors need to select sites they know can recruit the right patients, follow the study protocol, respect deadlines, report clinical results adequately and retain trial participants. This month, we present the third article in a series of three, on the top three questions to ask when conducting due diligence during CRO selection.
Can I clearly differentiate prices between CROs?
Although most respondents from the study are satisfied with the number of proposals they receive from CRO’s, one third of respondents are disappointed with the time the process takes. Many executives are dissatisfied with the process of comparing proposals, which generally takes several more days than they would like. The difficulty comes in that each CRO formats the quote in its own proprietary manner. Although the final figures are often easy enough to compare, change orders are common and frequent when outsourcing clinical trials. Determining how different changes in the trial will increase or decrease price is quite complicated when each change is calculated with a different formula for each CRO.
Several executives independently recommended improving the process by trying to maximize the similarity between proposals. Of these, two suggested attempting to convince CROs to fill out a cost template designed by the sponsor in addition to (or instead of) their own cost template. This would allow a more direct comparison between CROs, and flexibility in this area may point to flexibility in other necessary areas once the trial gets underway.
Once a company determines its strategy for sourcing, it begins the process CRO selection or vendors. It is important to recognize that each trial has unique pitfalls, and different CROs are positioned to deliver the best results depending on the trial constraints.
Figure A: Executives Involved In Selecting CROs
According to companies surveyed, a number of different people are involved in CRO selection. In about two thirds of companies, clinical trial managers or data operations executives are involved, as shown in Figure A (above). Clinical program directors or trial operations directors are involved in around one third of companies, and the biostatistics team provides input at 50% of all companies. Internal CRAs provide input at 25% of companies, but this number is much higher when companies that outsource the CRAs are excluded.
Cutting Edge Information’s research team has conducted a series of studies of clinical trial management trends and clinical outsourcing strategies in particular.
To learn more about the research findings in Cutting Edge Information’s Clinical Outsourcing report, download the summary here.