January 15, 2014
OASIS eTMF Standard TC selects architecture and format for eTMF data

OASIS eTMF Standard TC selects architecture and format for eTMF data

On Monday Jan 6 the OASIS eTMF Standard Technical Committee approved a three-tier technical architecture for the representation and exchange of electronic trial master file data. The technical architecture includes a Content Classification Layer, a Vocabulary Layer, and a Web Standard Technology Layer. Further, the team approved the use of RDF/XML to describe, share and […]
January 7, 2014
China Suspends Imports of HIV-Drug on Regulatory Doc Glitch

China Suspends Imports of HIV-Drug on Regulatory Doc Glitch

Some of you might be asking, “Why do I need a collaboration tool that streamlines the regulatory document completion process? Is it really that important?”  On Dec. 31st, there was a short article published in BioSpace that shines a spotlight on the very reason why eliminating paper-based regulatory documents in clinical trials makes sense. According to the […]
January 6, 2014
Not all Clouds Have a Silver Lining

Not all Clouds Have a Silver Lining

With the proliferation of software solutions containing sensitive data, many individuals, technologists, and corporations are rightfully concerned about the pervasive threat of large-scale penetration of private and public clouds. The hacking of big-box retailer Target in early December 2013 is a prime example of how malicious hackers can penetrate a network and abscond with private data. […]
December 18, 2013
The Start of a New Era for Clinical Trials

The Start of a New Era for Clinical Trials

There’s an important new global standards initiative that quietly launched on December 16th  in the BioPharma regulatory area called the OASIS eTMF Standard.   For clinical trial practitioners, the OASIS eTMF Standard represents a new high-water mark for delivering on the vision of 100% paperless clinical trials and clinical trial process automation across organization boundaries.   For […]