Clinipace

We recently authored an article in Drug Discovery & Development entitled “A Better Way to Conduct Clinical Research” espousing the virtues of technology adoption in running an efficient and productive clinical trial.

This article really is an extension to our corporate manifesto which is that technology can and should be deployed to bring much needed visibility to a clinical trial and enhance the productivity of clinical operations activities. Here are a few excerpts if you don’t feel like reading the whole article.

The business of taking drugs, biologics, and devices from the bench to the patient is under significant commercial, governmental, and social pressures regardless of the size of the company. Choosing a digital approach makes sense because these solutions can enable development teams to run trials cheaper, faster, and more efficient than paper-based approaches.

Smart CROs take advantage of technology by integrating it in the way people are deployed, driving productivity and increasing customer value. In my experience, when technology replaces people as the backbone of clinical research, the costs of clinical trials can drop by 20-30% depending on the size and scope of the study. As impressive as these cost reductions are, the more important result of technological innovation is real-time visibility into the study.

But not all CROs are the same. Most CROs and sponsors, while technologically savvy, still fall prey to the fundamental mistake of simply layering technology on top of existing manual processes. Adding technology to a flawed process—especially one that depends heavily on people paid by the hour—doesn’t reduce costs. It simply creates a more expensive and complicated process that is just as flawed as the original.

Dr. William McCulloch, president, Alba BioPharm Advisors, Inc., has worked as a senior R&D executive for large and small companies and notes that in his experience a dCRO gives a better understanding of what causes adverse events during clinical trials and allows for a faster follow-up. According to McCulloch, the ability to investigate a side effect in the seven days before it has to be reported to regulators may save a clinical trial.

Digitization also allows for real-time remote monitoring of investigator sites, cutting down the number of on-site visits required to ensure data is generated and collected according to protocol. Reducing the number of on-site visits in turn reduces the need for site monitors, while still allowing problems at far-flung sites to be detected and fixed much more quickly. “The gun fire is faster,” McCulloch said.