For a sponsor or investigator, selecting the right Clinical Research Organization (CRO) to help with the monitoring and management of a clinical trial can be crucial to a successful outcome.
So how does one go about selecting the best CRO for the job?
This article by Efraim Roe Kozorovitsky and Patrick Young drives home the most important considerations in the CRO selection process, focusing on the main criteria that should be considered to help guide the decision making process. We have modified this list slightly in order to include IMARC’s experience:
1 – Quality
Quality management and monitoring is directly linked to compliance with regulations. Be sure to ask about the quality certificates that the CRO holds and review their processes.
2 – Experience
Insist on seeing the credentials of the project team being proposed (do they have experience in the therapeutic area under investigation?). Confirm that they will be supported by involved executive management.
Ask for a client reference list, any CRO worth their salt will be happy to provide one.
3 – Capabilities
Assess the CRO’s capabilities throughout the regions the study will be performed. Will they be able to provide you with the services needed for the duration of the study?
All operating systems used by the CRO should be transparent and linked with each other, preventing duplicate activities.
4 – Cost
A determining factor in the current economic environment; when comparing different bids be aware of unit costs/line items and not just total cost. That low-cost proposal may not account for all study specifications and may lead to higher unexpected costs down the road.
… and we would like to add one further guideline to your decision making process…
5 – Relationships
We have recently met with several companies who have fired their CRO’s because their monitors upset staff at their sites. They were worried about their relationship with the sites being ruined, and were quite sensitive to the “types” of personalities we had on our staff.
A healthy relationship between the monitor and a site is critical to achieving compliance. This point is certainly something a sponsor should consider.
Always keep in mind that the CRO you select will be an extension of your team. Their actions at a site can either help or hurt your company.
Do you have any additional criteria you would add to the list? Let us know in the comments section below.
Photo Credit: Leo Reynolds