Clinical Trial Budget Negotiation and Staffing within our New Technology World

Frustration over Clinical Trial budget negotiation and how to staff accordingly is not a new challenge for a Clinical Research site.   The challenge has increased significantly over the past several years with the multitude of technology innovations that have been infused into a protocol from what used to be simple data collection and source documentation.   Sites are concerned with the additional resources needed and the costs to finance these resources are making it more difficult for the site to be successful.  Most Sponsors do realize that there is a direct correlation between a properly funded site and their contribution to an efficacious trial.   Many sites however do not feel that Sponsor’s understand the cost burden these technologies have actually placed. Besides a well-documented and detailed cost analysis, sites now need to dig deeper into the multitude of different technology innovations used for a protocol, understand the different resources required, plan effectively, staff smartly, reflect this in the budget and be ready to negotiate fairly and effectively.  A site’s economic success in today’s Technology World depends on this.