CRO Woes: Are Companies Better Off Using In-house Resources?

This was originally published in The Pharma Letter.  Click here to read the full article.

A decade ago, experts were predicting further integration of contract research organizations (CROs) in clinical trials. And for the most part, they were right. What used to be a vertical, top-down, fixed reporting model industry swiftly shifted to a mixed model utilizing both internal and external resources to conduct clinical trials. But as companies steadily increased their dependence on outside resources, cracks in the system started to show. In recent years, companies have examined the amount of effort and resources it takes to oversee these external resources, as well as the quality of work and the cost associated with them, and the results were not pretty. This has led some of the most “innovative” companies to rethink their outsourcing models altogether. They are bringing certain functions back in-house to reduce the amount of work out-sourced throughout all phases of clinical trials, from conception to completion.

Is reverting to an insourcing model the right move? Is there truly no benefit to using CROs instead of in-house resources to plan and execute clinical trials?

In a perfect world, CROs provide benefit by being true operational and strategic partners to the sponsor – it is not just a transactional relationship but one that moves beyond the basic execution of a clinical trial. In this “perfect” case, the CRO’s efficient involvement alleviates the burden on internal resources. With the proper relationship in place and the appropriate team in-house to manage that relationship, a balance is struck between responsibilities that fall to the CRO and those that are taken on internally, with seamless coordination and little duplication of resources. This, along with the location-specific and indication-specific trial expertise the CRO provides, makes the conduct of the trial quicker, cheaper, and less cumbersome for the sponsor while providing better experiences and outcomes for all parties involved, including the sponsor, the clinical site personnel, and ultimately the patients.

Continue reading at The Pharma Letter.