Clinical Trials Managed in “The Cloud?”

The fundamental concept of cloud computing dates back to the 1960s, when John McCarthy was quoted as saying “computation may someday be organized as public utility.”

The fundamental concept of cloud computing dates back to the 1960s, when John McCarthy was quoted as saying “computation may someday be organized as public utility.”

Today the concept of cloud computing has grown to the point of enticing even the FDA, Australian National Health and Medical Research Council (NHMRC)and other countries to look at cloud attributes or electronic source (“e-source”) for clinical trials processes. The FDA hopes to provide guidance to the clinical trials industry with the modest goal of simplifying and modernizing the mounting complexities of global clinical trials. Late last year the FDA released a draft guidance source, or “e-source” intended to augment its previous recommendations about software and clinical research. In short, the FDA is attempting to guide the pharmaceutical and research communities toward s a more modern, efficient, reliable, and systematic process.

Here is the link to the entire guidance: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM239052.pdf

But modernity won’t come easy for amazingly, there are still a large number of clinical trials professionals that belong to pagan groups that worship paper. It has been said that 40%+ of clinical trials are still managed on paper. The speedy growth of electronic systems has created a highly competitive “e-clinical” environment that now threatens the paper worshippers.

Earlier this Spring, the FDA partnered with The Drug Information Association (DIA) to host a 90-minute web seminar intended to discuss the new guidance draft. Leonard Sacks, the acting director of the Critical Path research agenda at the FDA was quoted as saying, “We think it will make trials easier for sponsors. We think it will reduce costs. We think it will make the performance of clinical trials more efficient and quick. We’re hoping that the rest of the medical community will join us in shepherding this ahead. We’re looking forward to a new realm of clinical trials.”

A simple definition of “e-clinical” used within the biopharmaceutical industry to refers to electronic solutions for automating the management and/or conduct of clinical trials with the aim of replacing manual, ad hoc or paper-driven methods.

Companies currently offering “e-clinical” solutions for sponsor companies and CRO’s:

• Medidata
• BioClinica
• KIKA Medical
• Omnicomm Systems
• eResearch Technology
• Prelude Dynamics
• Clinipace
• DATATRAK
• Phase Forward/Oracle
• Perceptive Informatics
• Clinplus

–Chelli Miller