Top Five Tips
How does a company evaluate a CRO?
Nowadays, both large pharmaceutical and small biotech companies are much more likely to outsource projects to CROs than they might have been in the past. In the 2016 outsourcing survey done by Contract Pharma, 80 percent of 315 pharmaceutical executives who responded said that they would increase their use of outsourcing in order to “focus more on core competencies,” among other reasons, according to an article by Ray Tobey in The ClinSmart Blog.
Still, according to the article, the selection process for outsourcing is difficult. There are many CROs, and companies who want to work with them need to determine appropriate evaluation criteria. While the selection of a CRO may not be different from selecting other types of vendors, the implications may be more far-reaching. Because the CRO can be regarded as an extension of the company’s own team, there are subtle nuances in the relationship. Choosing the appropriate CRO to outsource and/or manage a clinical trial is critically important in the successful outcome of the program.
Tobey recommends evaluating CROs on five criteria. The first is to determine what services are needed. After figuring out specific tasks to be outsourced, companies can investigate various CROs to determine that they have the capabilities needed and the bandwidth to provide support for the duration of the study. Secondly, a biotech or pharma should investigate a CRO’s experience relative to the client company’s therapeutic area and ask for references. If the CRO has experience with the client’s therapeutic areas, there is potential access to sites and patients.
Next, the biotech or pharma company should determine that there is proper regulatory and quality control at the CRO. If the research is being done in the US, it is especially critical for the CRO to have in-depth regulatory knowledge and appropriate quality control procedures and documentation, according to Tobey. He also recommended that prospective client companies “get a feel for [the CRO’s] communication style and level of transparency.” He added that “all systems used with a CRO partner should be transparent, linked with each other and accessible” to the client system. Such a system avoids duplication while assuring timely problem solving.
A biotech or pharma company seeking a CRO needs to do a detailed cost comparison. The CRO’s initial proposal must include all study specifications to eliminate unexpected costs at a later date. Choosing a CRO is tantamount to choosing a team member, and the appropriate amount of effort must be exercised, Tobey summarized.
One such CRO, DSCS Sweat Equity & Investments, was created in 2014 to reduce operational inefficiencies in clinical research. Whether that means helping research sites with business development or clinical operations; assisting a sponsor with patient recruitment efforts, CRA training or staffing issues; or connecting potential investigators to sponsors seeking qualified sites, DSCS Sweat Equity & Investments brings together its resources to speed up the drug development process. For more information, visit http://www.DSCSCRO.com.