Cloud Computing in Clinical Trials

What is Cloud Computing?

From the National Institute of Standards and Technology, “Cloud computing is a model for enabling ubiquitous, convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction.”

Cloud computing is turning the use of servers as a service and not as a property. You do not need to own it, but order it as you need it, when you need it, and how much you need. It will ease the process of bringing stuff online and make it available for use globally. The following lists a few of the benefits of cloud computing in clinical research.

  1. Improved Study Control: As a result of enhanced clinical trials information, such as user views and permissions, and trial location requirements, decisions can be made faster by the clinical trial manager. You can proactively review and manage each trial location and data entry professional as well as monitor requirements in real-time; giving you the information you need to make decisions faster.
  2. Real-Time Reporting: Data is always available in real-time. Information is generated directly from the system itself; no need to supplement system reports due to data transfer lag time. That means the system automatically triggers inventory changes, provides immediate notification of Serious Adverse Events, and gives you the information you need to make decisions, faster. Real-time data lets you quickly make decisions and provides the highest quality data for risk-based monitoring.
  3. Access Data from Any Device: The ability to access data from any device, for example a mobile, laptop, tablet or workstation, means that the physical location of the study, those involved, and the data, do not have to be considered.
  4. Saves Money: With lower IT costs because you don’t need to purchase or rent storage space for the use of the product, you reduce your IT spend.
  5. Saves Time: Completely eliminate time requirements needed to install licensed software. You receive your logon access and you begin. There are no software updates to install or track. The software is always up-to-date, ready to respond.
  6. Keeping things secure: Technology can offer data security to personal information of patients. With data theft on the rise in hospitals the issue is of great concern to clinical professionals, and cloud services offer a comprehensive multi-layered portfolio of managed security services to keep patient information safe.

On the contrary, there could be an argument that clouds could be obvious targets for those who are wishing to steal data. This no longer involves ‘amateur’ hacking; it is a sophisticated criminal activity, with trial data being viewed as having a re-sale value. Hence, Data security must support compliance with the Food and Drug Administration’s (FDA) Title 21 Code of Federal Regulations (CFR), specifically Part 11, the Electronic Records; Electronic Signatures rule that requires computer systems and controls be available for FDA inspection. Stakeholders must therefore be rigorous with finding the right cloud technology provider, which is sensitive to the particular elements of life science and clinical trial data security and regulations.