By Ray Tobey, Chief Medical Officer on Aug 16, 2017 11:10:54 AM
The trend of outsourcing in both small biotech and large pharmaceutical companies is moving upward. In fact, Contract Pharma’s 2016 Annual Outsourcing Survey showed that 80% of their 315 executive pharmaceutical respondents indicated an increase demand for outsourcing with the number one reason to focus more on core competencies (1).
Yet, the outsourcing selection process is not easy. With so many CROs to choose from, what kind of evaluation criteria should be used? In many ways, choosing a CRO is no different than choosing any other vendor; however, the relationship between a company and a CRO also has its own unique nuances since these organizations are essentially an extension of your team. Therefore, selecting the right CRO to outsource and/or manage a clinical trial can be a critical decision in the program’s successful outcome.
Here we suggest evaluating CROs based on the following five categories:
1. Determine what services you need
Once you determine the specific tasks that you need to outsource, you can investigate the various CROs to see what they offer. Once you have this list of applicable CROs, you will also need to determine that are able to support you for the duration of your study.
2. Investigate their experience relative to your therapeutic area
The extent of familiarity and experience with therapeutic areas you are working in will prove invaluable. With experience, comes the potential access to sites and patients. Take note, it is quite common to ask for a reference list.
3. Ensure proper regulatory and quality control is in place
In the US market, in-depth regulatory knowledge and appropriate quality control procedures and documentation is of utmost importance. This area is quite complex and having a qualified and experienced team handling these issues will prove invaluable.
4. Get a feel for their communication style and level of transparency
All systems used with your CRO partner should be transparent, linked with each other and accessible to you and your team. This will help teams to not duplicate activities and ensure promptness in problem resolution and cooperation. This level of open communication will help facilitate easier. As mentioned, proper selection of a CRO is as essential as selecting another member of your team. A healthy and communicative relationship between CRO and company can make or break the deal.
5. Carefully compare costs
It seems that no matter what the economic climate, cost is always a determining factor. Although lower cost may look attractive, it is important to ensure that the CRO proposal accounts for all study specifications. You want to eliminate higher unexpected costs down the road that were not initially included in the plan.
In summary, choosing a CRO is similar to choosing another member of your team. Do you have any additional criteria you would add to the list? Let us know in the comments section below.
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