"Non-Traditional CROs" Find Solutions While Managing Costs

 In the 1970’s and 1980’s pharmaceutical and biotechnology companies started to outsource many of the clinical operations services to organizations that have come to be known as contract research organizations (CROs). “Traditional CROs” established themselves by hiring and training employees to manage and monitor clinical trials. The individuals selected included those preferably with a scientific background and were most often fresh out of college or nursing school. The training they received was essential as they lacked experience in a fledgling industry. Strict supervision was also required based on low levels of experience. CRAs with zero to two years of experience made up the majority of the workforce and it was difficult for Traditional CROs to find CRAs with the requisite experience to appoint to studies. Therefore, many organizations sought to have blended teams of the more experienced monitors (3 or more years), along with ‘green staff’ or very inexperienced monitors (0 to 2 years). Many of these organizations were financially successful using this approach, yet it was significantly inefficient in terms of time and client’s budget.

To compensate for the lack of experienced staff, organizations needed multiple reviews by accomplished managers before documents could be released, a series of routine basic trainings to address shortcomings in the staff knowledge base, and intensified relationship managers that could mediate when there were operational issues that needed addressing. To closely oversee these staffs, brick and mortar facilities were set-up to help facilitate such necessary close supervision. All of these requirements added significant overhead to the budgets put forth by traditional CROs as it was up to the sponsors to pay for this inefficient business model.