Standardizing CRO Costs and Expectations


With the ever-increasing costs associated with conducting clinical trials, many medical device and pharma companies continue outsourcing various operational pieces to contract research organizations (CROs) and other augmentation service groups. By doing so, they are often saving money and the trials are typically completed faster (up to 30%) than when kept in-house (American Pharmaceutical Review ).

As the number of CRO options increase, many of these organizations are raising their prices to meet the demands of the growing market. Inherently, there is currently no baseline standard to these prices and many major CROs choose not to publicly disclose the costs of their services.  These services typically include combinations/variations of site monitoring, project management, case proctoring, safety management and post-trial reporting. What is the upside to standardizing these costs?  Could it be advantageous for all to, at least, provide a framework of fair market values for the various trial “touches” identified within the average schedule of events?  Some feel that without establishing more clear parameters, the pricing for CRO services may continue to creep,  possibly getting out of hand.  However, the more realistic effect is the continued outsourcing trend, possibly leading (forcing?) CROs to hire less experienced work-forces.  How may this influence the timelines of your study?  This is the question begging an answer.

As most are aware, the Sunshine Act has helped to establish fair market value by requiring “manufacturers of drugs, medical devices, and biologicals that participate in U.S. Federal Health Care programs to track and then report certain payments and items of value given to U.S. physicians and U.S. teaching hospitals” (Celgene). Considering this type of governance is the future of our industry, why not be proactive and have the discussion?

Frankly, many organizations are operating “under the radar” with regard to these kinds of transparencies – particularly costs of services and how they pair with CRA’s level of experience. The good news is, there are some industry-related organizations that are providing their menu of services and detailed staff biographies without hesitancy. Even better, the associated costs are an email or call away. The result? Sponsors can move more quickly with their partnership decisions, istantly trimming timelines and and reducing the “fog” of negotiation. With this approach, true competition evolves in the areas that matter; quality of work and a cohesiveness born of mutual trust.

Safety in numbers can be a misleading statement. In the end, let the market leaders be determined by who has the best reputation and the best talent. Isn’t that what we’re all looking for in business?