From the “Doctor’s Corner”


Birth of a New Entity — The IRO or Independent Research Organization
(Sometimes called the Innovative Research Organization)

Clinical trials have been progressing quickly and rather quietly as they have moved rapidly beyond the boundaries of the time-honored model for conducting clinical research. These models have been dictated largely by “big pharma” and have worked remarkably well for at least fifty years, but they are becoming so unwieldy that a growing number of study failures is demanding this creative new approach to simplify the existing approach to conducting trials in clinical research so that it is unified and can still meet every existing regulatory requirement.

Traditionally, pharma has identified promising molecules or devices that, when refined, can either eliminate specific diseases or massively reduce their impact. The intended end-game for pharma has always been to accomplish two basic goals.
  1. Reduce the burden of disease on mankind, and
  2. To make a hefty profit.
Pharma has been remarkably successful in accomplishing both goals.

But as the pharma industry has evolved, so too have the regulatory requirements that must always be met. This evolution has created a body of standards and requirements that are behemoth and meeting them has become ever-more costly and complex. And so it is, that the IRO has arrived on the scene, and it has done so with immediate acceptance as an alternative for conducting high-quality research. Many reasons exist for the enthusiastic response to these IROs and I will mention only the most obvious features of their appeal. First, they are typically smaller and more agile. Additionally, they are often owned and led by accomplished scientists from multiple disciplines within the research domain. As a result, they tend toward being “infra-structure light” and heavy on savvy and experience.

The arrival of multiple IROs has proven to be a win-win situation for Circlebase and our IRO partners for several reasons. The best part of these newly forming partnerships between the IRO and Circlebase is that invariably, no company is positioned to provide every functionality required to do integrated research. In one instance, we have a partner with a very mature IRO model, but they requested our assistance with automating patient identification by using our ACTM (Automated Clinical Trial Management) solution. As a result, sustainment has been improved because patient selection for trials has eliminated many participants who were not a good fit for the study. This also represents a reduction in the number of “screen fails” after much time has already been spent in previously identifying such patients who were erringly thought to be “eligible”.

Another partner has been a pharma group who is seeking to automatically reduce the time required to translate essential protocol detail into a functioning eCRF.  It has been estimated that each day of delay in creating these eCRF’s from the parent study protocol represents a loss of $550K to $750K. One could easily expand the description of benefits that forming a partnership with Circlebase has created.

However, it is enough to say that the terms “win-win” and “beneficial” are extremely meaningful for both Circlebase and our partners as we all look to our future.