BSDM & IT: eCT and Cloud Computing for CFR Part 11 Compliance
Thursday, July 12 2012
12:00 pm – 2:00 pm
Location: MassBio, 300 Tech Square, 8th Floor, Cambridge, MA 02139
Cloud computing architectures are becoming more common across many industries. They are a powerful and exciting innovation that has the potential to transform the systems we use in the clinical trial process. This presentation will explore some basic definitions of cloud computing, some of the variations of this type of architecture, and some possible applications to storing regulated clinical data in the Cloud. We will then discuss the risks and benefits to the key clinical applications listed below. We will end with a brief discussion of some of the obstacles that exist today that prevent the widespread use of cloud computing for clinical trials andsome ideas to overcome those obstacles.
- Kevin Ahonen, Associate Director, Clinical Technology at Biogen Idec
Some key clinical applications to be discussed are:
-Regulated document creation and approval systems
-Investigator relationship management
-Trial modeling system
-Secure document hubs/exchange
-Drug Supply Management system
-Analysis and reporting tools
Target audience: Quality Assurance, Quality Systems, Clinical Operations, Clinical Data Management, IT and any others who may be responsible for clinical trial systems.